Atrial Fibrillation Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of Lovaza for the Prevention of Recurrent, Symptomatic Atrial Fibrillation
| Verified date | February 2012 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.
| Status | Completed |
| Enrollment | 663 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Men and women age 18 years or older - History of symptomatic atrial fibrillation (either paroxysmal or persistent) - Provide written informed consent and authorization for protected health information disclosure Exclusion Criteria: - Permanent (chronic) atrial fibrillation - Antiarrhythmic drug therapy which cannot be stopped - Use of amiodarone with prior 6 months - History of unsuccessful cardioversion - History of certain cardiovascular conditions or cardiac surgery within prior 6 months - History of stroke within prior 6 months - Implanted cardio-defibrillator - Certain circulatory, thyroid, pulmonary, liver, kidney, musculoskeletal or metabolic conditions, or cancer (except non-melanoma skin cancer) - Poorly controlled diabetes |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Investigational Site | Akron | Ohio |
| United States | GSK Investigational Site | Alamada | California |
| United States | GSK Investigational Site | Alpena | Michigan |
| United States | GSK Investigational Site | Anchorage | Alaska |
| United States | GSK Investigational Site | Annapolis | Maryland |
| United States | GSK Investigational Site | Arlington | Virginia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Auburn | Maine |
| United States | GSK Investigational Site | Aurora | Colorado |
| United States | GSK Investigational Site | Austin | Texas |
| United States | GSK Investigational Site | Aventura | Florida |
| United States | GSK Investigational Site | Ayer | Massachusetts |
| United States | GSK Investigational Site | Babylon | New York |
| United States | GSK Investigational Site | Bakersfield | California |
| United States | GSK Investigational Site | Bakersfield | California |
| United States | GSK Investigational Site | Bannockburn | Illinois |
| United States | GSK Investigational Site | Bay Pines | Florida |
| United States | GSK Investigational Site | Beaumont | Texas |
| United States | GSK Investigational Site | Beaver | Pennsylvania |
| United States | GSK Investigational Site | Beloit | Wisconsin |
| United States | GSK Investigational Site | Beverly Hills | California |
| United States | GSK Investigational Site | Biddeford | Maine |
| United States | GSK Investigational Site | Billings | Montana |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Bridgeport | Connecticut |
| United States | GSK Investigational Site | Brookline | Massachusetts |
| United States | GSK Investigational Site | Bryan | Ohio |
| United States | GSK Investigational Site | Buffalo | New York |
| United States | GSK Investigational Site | Buffalo | New York |
| United States | GSK Investigational Site | Burien | Washington |
| United States | GSK Investigational Site | Cadillac | Michigan |
| United States | GSK Investigational Site | Carmichael | California |
| United States | GSK Investigational Site | Charlotte | North Carolina |
| United States | GSK Investigational Site | Charlotte | North Carolina |
| United States | GSK Investigational Site | Chesapeake | Virginia |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Colorado Springs | Colorado |
| United States | GSK Investigational Site | Corpus Christi | Texas |
| United States | GSK Investigational Site | Corvalis | Oregon |
| United States | GSK Investigational Site | Cottonwood | Arizona |
| United States | GSK Investigational Site | Covington | Louisiana |
| United States | GSK Investigational Site | Cranston | Rhode Island |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Daytona Beach | Florida |
| United States | GSK Investigational Site | Decatur | Georgia |
| United States | GSK Investigational Site | Delray Beach | Florida |
| United States | GSK Investigational Site | Detroit | Michigan |
| United States | GSK Investigational Site | Elkhart | Indiana |
| United States | GSK Investigational Site | Fair Oaks | California |
| United States | GSK Investigational Site | Fairview Park | Ohio |
| United States | GSK Investigational Site | Farmington | Connecticut |
| United States | GSK Investigational Site | Fort Meyers | Florida |
| United States | GSK Investigational Site | Fort Smith | Arkansas |
| United States | GSK Investigational Site | Fountain Valley | California |
| United States | GSK Investigational Site | Gainesville | Florida |
| United States | GSK Investigational Site | Galax | Virginia |
| United States | GSK Investigational Site | Grand Forks | North Dakota |
| United States | GSK Investigational Site | Greensburg | Pennsylvania |
| United States | GSK Investigational Site | Greer | South Carolina |
| United States | GSK Investigational Site | Guilford | Connecticut |
| United States | GSK Investigational Site | Gulfport | Mississippi |
| United States | GSK Investigational Site | Gurnee | Illinois |
| United States | GSK Investigational Site | Hershey | Pennsylvania |
| United States | GSK Investigational Site | Hickory | North Carolina |
| United States | GSK Investigational Site | Hillsboro | Oregon |
| United States | GSK Investigational Site | Hot Springs | Arkansas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Hudson | Florida |
| United States | GSK Investigational Site | Humble | Texas |
| United States | GSK Investigational Site | Huntington | West Virginia |
| United States | GSK Investigational Site | Huntsville | Alabama |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Jackson | Tennessee |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | Jupiter | Florida |
| United States | GSK Investigational Site | Kalamazoo | Michigan |
| United States | GSK Investigational Site | Kalispell | Montana |
| United States | GSK Investigational Site | Kansas City | Kansas |
| United States | GSK Investigational Site | Kissimmee | Florida |
| United States | GSK Investigational Site | La Porte | Indiana |
| United States | GSK Investigational Site | Lacombe | Louisiana |
| United States | GSK Investigational Site | Langhorne | Pennsylvania |
| United States | GSK Investigational Site | Lansing | Michigan |
| United States | GSK Investigational Site | Largo | Florida |
| United States | GSK Investigational Site | Littleton | Colorado |
| United States | GSK Investigational Site | Loma Linda | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Lubbock | Texas |
| United States | GSK Investigational Site | Madison | Wisconsin |
| United States | GSK Investigational Site | Marshfield | Wisconsin |
| United States | GSK Investigational Site | McKinney | Texas |
| United States | GSK Investigational Site | Melbourne | Florida |
| United States | GSK Investigational Site | Memphis | Tennessee |
| United States | GSK Investigational Site | Merced | California |
| United States | GSK Investigational Site | Mesa | Arizona |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | Mineappolis | Minnesota |
| United States | GSK Investigational Site | Mineola | New York |
| United States | GSK Investigational Site | Missoula | Montana |
| United States | GSK Investigational Site | Morristown | New Jersey |
| United States | GSK Investigational Site | Mount Sterling | Kentucky |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Normal | Illinois |
| United States | GSK Investigational Site | Ocala | Florida |
| United States | GSK Investigational Site | Odessa | Texas |
| United States | GSK Investigational Site | Odessa | Texas |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Orange | Texas |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Ormond Beach | Florida |
| United States | GSK Investigational Site | Palm Springs | California |
| United States | GSK Investigational Site | Pawtucket | Rhode Island |
| United States | GSK Investigational Site | Pensacola | Florida |
| United States | GSK Investigational Site | Peoria | Illinois |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Pinellas Park | Florida |
| United States | GSK Investigational Site | Portland | Maine |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Poway | California |
| United States | GSK Investigational Site | Redondo Beach | California |
| United States | GSK Investigational Site | Richlands | Virginia |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Ridley Park | Pennsylvania |
| United States | GSK Investigational Site | Rochester Hills | Minnesota |
| United States | GSK Investigational Site | Sacramento | California |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | Scarborough | Maine |
| United States | GSK Investigational Site | Sioux Falls | South Dakota |
| United States | GSK Investigational Site | South Bend | Indiana |
| United States | GSK Investigational Site | Spartanburg | South Carolina |
| United States | GSK Investigational Site | Springfield | Virginia |
| United States | GSK Investigational Site | St Paul | Minnesota |
| United States | GSK Investigational Site | Statesville | North Carolina |
| United States | GSK Investigational Site | Summit | New Jersey |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Troy | New York |
| United States | GSK Investigational Site | Tucker | Georgia |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Tyler | Texas |
| United States | GSK Investigational Site | Vista | California |
| United States | GSK Investigational Site | Waco | Texas |
| United States | GSK Investigational Site | Walnut Creek | California |
| United States | GSK Investigational Site | Washington | District of Columbia |
| United States | GSK Investigational Site | Washington | District of Columbia |
| United States | GSK Investigational Site | Wausau | Wisconsin |
| United States | GSK Investigational Site | Wayne | New Jersey |
| United States | GSK Investigational Site | West Chester | Pennsylvania |
| United States | GSK Investigational Site | West Islip | New York |
| United States | GSK Investigational Site | Westerly | Rhode Island |
| United States | GSK Investigational Site | Worcester | Massachusetts |
| United States | GSK Investigational Site | Wynnewood | Pennsylvania |
| United States | GSK Investigational Site | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
Kowey PR, Reiffel JA, Ellenbogen KA, Naccarelli GV, Pratt CM. Efficacy and safety of prescription omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: a randomized controlled trial. JAMA. 2010 Dec 1;304(21):2363-72. doi: 10 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter | A documented episode of symptomatic AF /Flutter was defined as AF/Flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter. | From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24) | No |
| Secondary | Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter | A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter. | From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24) | No |
| Secondary | Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF. | From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24) | No |
| Secondary | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF. | From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24) | No |
| Secondary | Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter. | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24) | No |
| Secondary | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter. | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24) | No |
| Secondary | Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter. | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24) | No |
| Secondary | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter. | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24) | No |
| Secondary | Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter. | From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24) | No |
| Secondary | Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter. | From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24) | No |
| Secondary | Number of Participants With Paroxysmal or Persistent AF With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter) | A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF. | From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24) | No |
| Secondary | Number of Participants in the Combined AF Subgroups With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter) | A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF. | From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24) | No |
| Secondary | Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period | Rescue was defined as any pharmacological/electrical/surgical intervention for the termination/prevention of AF/flutter with a maximum of one rescue episode counted per day. Note: all annualized values were calculated by counting the number of rescue episodes, dividing by the number of days on treatment, then multiplying that number by 365.25. | From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) | No |
| Secondary | Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period | Values were annualized by counting the number of episodes of symptomatic AF/flutter recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25. | From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) | No |
| Secondary | Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period | Values were annualized by counting the number of episodes of symptomatic AF recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25. | From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) | No |
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