Ventricular Tachycardia Clinical Trial
— UNTOUCHEDOfficial title:
Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
NCT number | NCT02433379 |
Other study ID # | 91026550 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 9, 2015 |
Est. completion date | December 6, 2019 |
Verified date | November 2020 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study assesses the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp in order to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The incidence of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks observed in the MADIT RIT study.
Status | Completed |
Enrollment | 1173 |
Est. completion date | December 6, 2019 |
Est. primary completion date | December 6, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Patient with ischemic or non-ischemic heart disease who meets current guidelines for ICD therapy and intends to undergo a de novo implant procedure for an EMBLEM™ S-ICD (or newer generation BSC S-ICD) - Left ventricular ejection fraction = 35% - A passing EMBLEM™ S-ICD (or newer generation BSC S-ICD) screening ECG - Patient = 21 years of age willing and capable of giving informed consent - Patient willing and capable of complying with follow-up visits Exclusion Criteria: - Patient with a history of spontaneous sustained VT or VF - Patient with bradycardia pacing indication - Patient eligible and scheduled for cardiac resynchronization implant - Patient with a previous S-ICD or a previous transvenous pulse generator (pacemaker or defibrillator) - Patient in NYHA Class IV documented in the medical records within 90 days before enrollment - Patient with life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…) - Patient receiving hemodialysis within 180 days before to enrollment - Patients unable to give consent in person, including patients unable to read or write - Patient who is known to be pregnant or plans to become pregnant over the course of the trial - Patient unwilling or unable to cooperate with the protocol - Participation in concurrent clinical study without prior approval from Boston Scientific - Medical status (e.g., hemodynamic conditions ) of the patient doesn't allow programming devices with a conditional shock zone at 200 bpm and a shock zone at 250 bpm, in the judgment of the implanting physician and/or according to (inter) national guidelines |
Country | Name | City | State |
---|---|---|---|
Belgium | Clinique Saint-Jean | Brussels | |
Belgium | Universitair Ziekenhuis Gent | Gent | |
Canada | Institut universitaire de Cardiologie et de Pneumologie de Quebec | Ste-Foy | Quebec |
Denmark | University Hospital | Odense | |
France | CH Annecy | Annecy | |
France | CHU Dijon | Dijon | |
France | CHRU de Lille | Lille | |
France | CHU La Timone Hospital | Marseille | |
France | CHU Montpellier | Montpellier | |
France | Hospital de la Pitie-Salpetriere | Paris | |
France | CHRU Hopital Pontchaillou | Rennes | |
France | Nouvel Hôpital Civil De Strasbourg | Strasbourg | |
France | Clinique Pasteur | Toulouse | |
France | CHRU Nancy Brabois | Vandoeuvre Les Nancy | |
Germany | Deutsches Herzzentrum Berlin | Berlin | |
Germany | Unfallkrankenhaus Berlin Marzahn | Berlin | |
Germany | University Hospital Frankfurt | Frankfurt | |
Germany | Universitaetsmedizin Greifswald | Greifswald | |
Germany | Universitaetsklinik Eppendorf | Hamburg | |
Germany | Universitaetsklinikum Heidelberg | Heidelberg | |
Germany | University Hospital of Muenster | Muenster | |
Italy | Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | |
Italy | Azienda Ospedaliero Universitaria Pisana | Pisa | |
Italy | Azienda Ospedaliera Universitaria Integrata di Verona | Verona | |
Netherlands | Academisch Medisch Centrum | Amsterdam | |
Netherlands | St. Antonius Ziekenhuis | Nieuwegein | |
Netherlands | Erasmus MC - University Medical Center Rotterdam | Rotterdam | |
Poland | Centralny Szpital Kliniczny Uniwerytetu Medycznego | Lodz | |
Puerto Rico | Hospital San Lucas | Ponce | |
Spain | Hospital Clinico San Carlos | Madrid | |
Spain | Hospital Virgen De La Salud | Toledo | |
Spain | Hospital Miguel Servet | Zaragoza | |
Switzerland | Cardiocentro Ticino | Lugano | |
Switzerland | University Hospital Zurich | Zuerich | |
United Kingdom | Blackpool Victoria NHS Trust Direct | Blackpool | |
United Kingdom | Russels Hall Hospital | Dudley | |
United Kingdom | Glenfield Hospital | Leicester | |
United Kingdom | Cardiothoracic Centre | Liverpool | |
United Kingdom | St. Bartholomews Hospital | London | |
United Kingdom | Northern General Hospital | Sheffield | |
United Kingdom | Southampton University Hospital | Southampton | |
United States | Abington Memorial Hospital | Abington | Pennsylvania |
United States | Albany Medical Center | Albany | New York |
United States | AnMed Health | Anderson | South Carolina |
United States | St. Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | Memorial Mission Hospital | Asheville | North Carolina |
United States | Emory University Hospital | Atlanta | Georgia |
United States | University Hospital | Augusta | Georgia |
United States | Alabama Cardiovascular Group | Birmingham | Alabama |
United States | Deborah Heart and Lung Center | Browns Mills | New Jersey |
United States | Cooper Hospital - University Medical Center | Camden | New Jersey |
United States | Aultman Hospital | Canton | Ohio |
United States | University of North Carolina Hospital | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | CorVita Science Foundation | Chicago | Illinois |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | Ohio State University Medical Center | Columbus | Ohio |
United States | Durham VA Medical Center | Durham | North Carolina |
United States | Northern Indiana Research Alliance - Lutheran Hospital | Fort Wayne | Indiana |
United States | Mercy Gilbert Medical Center | Gilbert | Arizona |
United States | Glendale Adventist Medical Center | Glendale | California |
United States | Huntsville Hospital - The Heart Center, PC | Huntsville | Alabama |
United States | Methodist Hospital of Indianapolis | Indianapolis | Indiana |
United States | St. Vincent's Hospital | Indianapolis | Indiana |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | Baptist Medical Center | Jacksonville | Florida |
United States | Evergreen Hospital Medical Center | Kirkland | Washington |
United States | Sharp Grossmont Hospital | La Mesa | California |
United States | HealthCare Partners Cardiology | Las Vegas | Nevada |
United States | University of Southern California Hospital | Los Angeles | California |
United States | Centra Stroobants Cardiovascular Center | Lynchburg | Virginia |
United States | St. Mary's Madison | Madison | Wisconsin |
United States | Yale University School of Medicine | New Haven | Connecticut |
United States | Northwell Health | New Hyde Park | New York |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | Beth Israel Medical Center | New York | New York |
United States | Cardiology Physicians PA | Newark | Delaware |
United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
United States | Alta Bates Medical Center | Oakland | California |
United States | The Nebraska Medical Center | Omaha | Nebraska |
United States | St. Joseph Hospital | Orange | California |
United States | Florida Hospital | Orlando | Florida |
United States | Mayo Clinic Phoenix | Phoenix | Arizona |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Rex Hospital | Raleigh | North Carolina |
United States | Virginia Commonwealth University Health System | Richmond | Virginia |
United States | Strong Memorial Hospital of the University of Rochester | Rochester | New York |
United States | CardioVascular Institute of Michigan P.C. | Roseville | Michigan |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | Centracare Heart and Vascular Center | Saint Cloud | Minnesota |
United States | HealthEast St. Joseph's Hospital | Saint Paul | Minnesota |
United States | Salem Hospital | Salem | Oregon |
United States | Peninsula Cardiology Associates | Salisbury | Maryland |
United States | University of Utah Hospital and Clinics | Salt Lake City | Utah |
United States | South Texas Veterans Health Care System | San Antonio | Texas |
United States | Good Samaritan Hospital - San Jose | San Jose | California |
United States | Cardiovascular Associates of the Delaware Valley | Sewell | New Jersey |
United States | Advanced Cardiovascular Specialists | Shreveport | Louisiana |
United States | Cox Health | Springfield | Missouri |
United States | Mercy Research | Springfield | Missouri |
United States | Sacred Heart Medical Center at Riverbend | Springfield | Oregon |
United States | CHI Franciscan Health System | Tacoma | Washington |
United States | Tallahassee Memorial Hospital | Tallahassee | Florida |
United States | The Toledo Hospital | Toledo | Ohio |
United States | Harbor UCLA Medical Center | Torrance | California |
United States | North Mississippi Medical Center | Tupelo | Mississippi |
United States | Trinity Mother Frances Health System | Tyler | Texas |
United States | Heartland Cardiology | Wichita | Kansas |
United States | Genesis Healthcare System | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
United States, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Puerto Rico, Spain, Switzerland, United Kingdom,
Boersma LV, El-Chami MF, Bongiorni MG, Burke MC, Knops RE, Aasbo JD, Lambiase PD, Deharo JC, Russo AM, Dinerman J, Shaik N, Barr CS, Carter N, Appl U, Brisben AJ, Stein KM, Gold MR. Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patien — View Citation
Gold MR, Knops R, Burke MC, Lambiase PD, Russo AM, Bongiorni MG, Deharo JC, Aasbo J, El Chami MF, Husby M, Carter N, Boersma L. The Design of the Understanding Outcomes with the S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED). Pacing Clin Electrophysiol. 2017 Jan;40(1):1-8. doi: 10.1111/pace.12994. Epub 2017 Jan 15. — View Citation
Gold MR, Lambiase PD, El-Chami MF, Knops RE, Aasbo JD, Bongiorni MG, Russo AM, Deharo JC, Burke MC, Dinerman J, Barr CS, Shaik N, Carter N, Stoltz T, Stein KM, Brisben AJ, Boersma LVA; UNTOUCHED Investigators*. Primary Results From the Understanding Outco — View Citation
Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, Estes NA 3rd, Greenberg H, Hall WJ, Huang DT, Kautzner J, Klein H, McNitt S, Olshansky B, Shoda M, Wilber D, Zareba W; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012 Dec 13;367(24):2275-83. doi: 10.1056/NEJMoa1211107. Epub 2012 Nov 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Percentage of Patients Not Experiencing a System or Procedure Related Complication From 0 to 180 Days (6 Months). | Post-Market Clinical Follow-up (PMCF) Endpoint: Freedom from System and Procedure Related Complications at 180 days (6 months) compared to a performance goal of 85%. This analysis was conducted for two sub-groups of UNTOUCHED Study subjects: 1.) the first 200 subjects implanted with an EMBLEM model A209 device; 2.) the first 200 subjects implanted with an EMBLEM model A219 device. The PMCF analysis prespecified in the study protocol only required a sub-set of the implanted UNTOUCHED Study subjects (i.e., 200 subjects for the EMBLEM A209 analysis and 200 for the EMBLEM A219 analysis; the full study cohort was not required for these two analyses). | 6 months | |
Primary | Percentage of Patients Who Did Not Experience an Inappropriate Shock From Their EMBLEM S-ICD | Primary endpoint: Inappropriate shock free rate from 0 to 540 Days (18-Months) compared to a performance goal of 91.6%. | 18 months | |
Secondary | Percentage of Participants Not Experiencing a System or Procedure Related Complication From 0 to 30 Days | Secondary safety endpoint: Freedom from System and Procedure Related Complications at 30 days compared to a performance goal of 93.8%. | 30 days | |
Secondary | Percentage of Subjects Free From All-cause Shock From Their EMBLEM S-ICD | Secondary efficacy endpoint: All-Cause Shock Free Rate at 540 days (18-months) compared to a performance goal of 85.8%. | 18 months |
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