Heart Failure Clinical Trial
Official title:
Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead
| Verified date | July 2018 |
| Source | Boston Scientific Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral Left Ventricular Lead.
| Status | Terminated |
| Enrollment | 1308 |
| Est. completion date | February 28, 2018 |
| Est. primary completion date | February 28, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Has been or will be implanted with the ACUITY Spiral Lead within 29 days - Plans to remain in the long-term care of his/her enrolling physician - Is willing and capable (or appropriate legal representative) of authorizing access to and use of health information as required by an institution's institutional review board (IRB) - Is willing and capable (or appropriate legal representative) of providing authorization for participation in the registry Exclusion Criteria: - Is unable or unwilling to comply with the protocol requirements |
| Country | Name | City | State |
|---|---|---|---|
| United States | Abington Memorial Hospital | Abington | Pennsylvania |
| United States | Capital Cardiology Associates | Albany | New York |
| United States | Phoebe Putney Memorial Hospital | Albany | Georgia |
| United States | Amarillo Heart Group | Amarillo | Texas |
| United States | Providence Alaska Medical Center | Anchorage | Alaska |
| United States | St. Joseph Mercy Hospital | Ann Arbor | Michigan |
| United States | Bethesda Memorial Hospital | Atlantis | Florida |
| United States | Medical College of Georgia Health | Augusta | Georgia |
| United States | Heart Hospital of Austin | Austin | Texas |
| United States | Texas Cardiac Arrhythmia Research | Austin | Texas |
| United States | Comprehensive Cardiovascular Medical Group | Bakersfield | California |
| United States | Overlake Medical Center | Bellevue | Washington |
| United States | St. Joseph Hospital | Bellingham | Washington |
| United States | Birmingham Heart Clinic | Birmingham | Alabama |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | St Lukes Idaho Cardiology Assoc. | Boise | Idaho |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Steward St. Elizabeth's Medical Center | Boston | Massachusetts |
| United States | Southern Kentucky Heart Institute | Bowling Green | Kentucky |
| United States | Mid-Carolina Cardiology | Charlotte | North Carolina |
| United States | Christ Hospital - Cincinnati | Cincinnati | Ohio |
| United States | Heart and Vascular Institute of Florida | Clearwater | Florida |
| United States | Columbia Cardiology | Columbia | South Carolina |
| United States | Missouri Heart Center | Columbia | Missouri |
| United States | Ohio State University Medical Center | Columbus | Ohio |
| United States | Riverside Methodist Hospital | Columbus | Ohio |
| United States | Heart Care | Detroit | Michigan |
| United States | St. Mary's Duluth Clinic | Duluth | Minnesota |
| United States | Belott Cardiology | El Cajon | California |
| United States | Cardiology Care Consultants | El Paso | Texas |
| United States | Alexian Brothers Medical Center | Elk Grove Village | Illinois |
| United States | Virginia Heart | Falls Church | Virginia |
| United States | Cardiology Consultants of East Michigan | Flint | Michigan |
| United States | PeeDee Cardiology Associates | Florence | South Carolina |
| United States | Northern Indiana Research Alliance | Fort Wayne | Indiana |
| United States | Fullerton Cardiovascular | Fullerton | California |
| United States | Northeast Georgia Heart Center | Gainesville | Georgia |
| United States | Island Cardiac Specialists | Garden City | New York |
| United States | West Michigan Heart | Grand Rapids | Michigan |
| United States | Associated Cardiologists | Harrisburg | Pennsylvania |
| United States | St. Mary Medical Center - Indiana | Hobart | Indiana |
| United States | Hall Garcia Cardiology | Houston | Texas |
| United States | Houston Electrophysiology Associates | Houston | Texas |
| United States | Willowbrook Cardiovascular Associates | Houston | Texas |
| United States | Cardiology Associates of Northeast Arkansas | Jonesboro | Arkansas |
| United States | Research Medical Center | Kansas City | Missouri |
| United States | Central Baptist Hospital | Lexington | Kentucky |
| United States | St. Joseph Hospital | Lexington | Kentucky |
| United States | Nebraska Heart Institute | Lincoln | Nebraska |
| United States | Heart Clinic Arkansas | Little Rock | Arkansas |
| United States | Cardiac Device Rhythm Specialists | Los Angeles | California |
| United States | Cedars - Sinai Medical Center | Los Angeles | California |
| United States | Commonwealth Cardiology | Louisville | Kentucky |
| United States | Georgia Arrhythmia Consultants | Macon | Georgia |
| United States | Richmond Cardiology Associates | Mechanicsville | Virginia |
| United States | Memphis Heart Clinic | Memphis | Tennessee |
| United States | Tri-City Cardiology | Mesa | Arizona |
| United States | Miami International Cardiology Consultants | Miami | Florida |
| United States | Memorial Hospital | Modesto | California |
| United States | Heart Care Research Foundation | Mokena | Illinois |
| United States | Intermountain Medical Center | Murray | Utah |
| United States | Complete Cardiology Care | New Smyrna Beach | Florida |
| United States | Columbia University Medical Center | New York | New York |
| United States | Cardiac Rhythm Specialists, Inc. | Northridge | California |
| United States | Cardiovascular Consultants | Oakland | California |
| United States | Orange County Heart Institute | Orange | California |
| United States | Orlando Regional Hospital | Orlando | Florida |
| United States | Albert Einstein Medical Center | Philadelphia | Pennsylvania |
| United States | Drexel University College of Medicine | Philadelphia | Pennsylvania |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Pinehurst Cardiology Consultants | Pinehurst | North Carolina |
| United States | Cardiovascular Associates of Rhode Island | Providence | Rhode Island |
| United States | Eisenhower Medical Center | Rancho Mirage | California |
| United States | Baltimore Heart Association | Randallstown | Maryland |
| United States | Heart Doctors | Rapid City | South Dakota |
| United States | Truong D Duong Cardiac Electrophysiology | Riverside | California |
| United States | Regional Cardiology Associates | Sacramento | California |
| United States | Dixie Regional Medical Center | Saint George | Utah |
| United States | Metro Heart Group South County | Saint Louis | Missouri |
| United States | Sansum Clinic | Santa Barbara | California |
| United States | Arizona Arrhythmia Research Center | Scottsdale | Arizona |
| United States | Swedish Medical Center | Seattle | Washington |
| United States | Providence Hospital | Southfield | Michigan |
| United States | Heart Clinics Northwest | Spokane | Washington |
| United States | Cox Health | Springfield | Missouri |
| United States | Regional Cardiovascular Medical Center | Steubenville | Ohio |
| United States | Tallahassee Memorial Hospital | Tallahassee | Florida |
| United States | EP Heart | The Woodlands | Texas |
| United States | West Coast Arrhythmia Center | Trinity | Florida |
| United States | Pima Heart Physicians | Tucson | Arizona |
| United States | Hillcrest Medical Center | Tulsa | Oklahoma |
| United States | Tyler Cardiovascular Consultants | Tyler | Texas |
| United States | Wheaton Franciscan Healthcare | Wauwatosa | Wisconsin |
| United States | New Jersey Cardiology Associates | West Orange | New Jersey |
| United States | Via-Christi Regional Medical Center | Wichita | Kansas |
| United States | Lankenau Hospital | Wynnewood | Pennsylvania |
| United States | Genesis Healthcare System | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Scientific Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Chronic Left Ventricular Lead-related Complication Free Rate | Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death). |
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