Shockless Implant Evaluation
- Conditions
- Ventricular TachycardiaVentricular Fibrillation
- Interventions
- Device: Implantable defibrillator
- Registration Number
- NCT00800384
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks.
The trial will test the hypothesis that implantable cardioverter defibrillator (ICD) implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death.
It will also test the hypothesis, that defibrillation testing increases the peri-operative (30 days) complication rate of ICD implantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2500
- Age ≥ 18 years
- Patients undergoing initial implant of an ICD or CRT-D device (can be upgrade from a pacemaker)
- Patients, who in the opinion of their treating physicians are ineligible for either strategy (DT or no DT)
- Patients on active transplant list
- Patients unwilling to provide informed consent
- Patients not available for follow-up
- Pregnancy or women of child bearing potential not following an effective method of contraception
- Anticipated right sided implantation of the ICD generator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Implantable defibrillator ICD implant with defibrillation testing 1 Implantable defibrillator ICD implant without defibrillation testing
- Primary Outcome Measures
Name Time Method First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death Mean follow-up of 3.1 years The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.
- Secondary Outcome Measures
Name Time Method Perioperative Complication Rate 30 days A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.
Trial Locations
- Locations (85)
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Sunnybrook & Women's College Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
IKEM - Institut klinicke a experimentalni mediciny
🇨🇿Prague, Czechia
CHU Grenoble - Hopital Michallon
🇫🇷Grenoble, France
CHRU de Lille
🇫🇷Lille, France
CHG de Pau
🇫🇷Pau, France
CHRU Nancy Brabois
🇫🇷Nancy, France
Zentralklinik Bad Berka
🇩🇪Bad Berka, Germany
CHRU Hopital Pontchaillou
🇫🇷Rennes, France
German Heart Center Berlin
🇩🇪Berlin, Germany
Evangelisches Krankenhaus Bielefeld
🇩🇪Bielefeld, Germany
Klinikum Coburg gGmbH
🇩🇪Coburg, Germany
University Hospital Bochum Bergmannsheil
🇩🇪Bochum, Germany
Klinikum Lippe-Detmold
🇩🇪Detmold, Germany
Klinikum Dortmund gGmbH
🇩🇪Dortmund, Germany
University Hospital
🇩🇪Frankfurt, Germany
Klinikum Kassel
🇩🇪Kassel, Germany
University Hospital Heidelberg
🇩🇪Heidelberg, Germany
Krankenhaus Landshut Achdorf
🇩🇪Landshut, Germany
Medizinische Klinik und Poliklinik I
🇩🇪Leipzig, Germany
Marienhospital Lünen
🇩🇪Lünen, Germany
Klinikum Ernst von Bergmann gGmbH
🇩🇪Potsdam, Germany
University of Rostock
🇩🇪Rostock, Germany
University Hospital of Muenster
🇩🇪Muenster, Germany
Klinikum Nuernberg Sued
🇩🇪Nuernberg, Germany
Klinikum Oldenburg GmbH
🇩🇪Oldenburg, Germany
Krankenhaus der Barmherzigen Brüder
🇩🇪Trier, Germany
Klinikum der Universitaet Regensburg
🇩🇪Regensburg, Germany
University Hospital Tübingen
🇩🇪Tübingen, Germany
Herzkreislaufzentrum Rotenburg
🇩🇪Rotenburg an der Fulda, Germany
University Hospital Ulm
🇩🇪Ulm, Germany
Heinrich Braun Krankenhaus
🇩🇪Zwickau, Germany
Hungarian Institute of Cardiology
🇭🇺Budapest, Hungary
Beilinson Medical Center
🇮🇱Petah-Tikva, Israel
Hospital Clinico Y Provincial
🇪🇸Barcelona, Spain
Hospital Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital De La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital 12 de Octubre Madrid
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital De Navarra
🇪🇸Pamplona, Spain
H. Clinico Universitario
🇪🇸Valencia, Spain
Karolinska Hospital
🇸🇪Stockholm, Sweden
St. Peters Hospital
🇬🇧Chertsey, United Kingdom
Ramathibodi Hospital
🇹🇭Bangkok, Thailand
Cardiothoracic Centre
🇬🇧Liverpool, United Kingdom
Freeman Hospital
🇬🇧Newcastle-upon-Tyne, United Kingdom
Landesklinikum St. Poelten
🇦🇹St. Poelten, Austria
Allgemeines Krankenhaus Wien
🇦🇹Vienna, Austria
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Wilhelminenspital
🇦🇹Vienna, Austria
Klinikum Wels - Grieskirchen
🇦🇹Wels, Austria
Royal Jubilee Hospital
🇨🇦Victoria, British Columbia, Canada
The Royal Melbourne Hospital
🇦🇺Melbourne, Australia
Institut de Cardiologie de Montreal
🇨🇦Montreal, Quebec, Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec
🇨🇦Québec, Quebec, Canada
Fleurimont Hospital
🇨🇦Sherbrooke, Quebec, Canada
Tampere University Hospital
🇫🇮Tampere, Finland
Prince of Wales Hospital
🇭🇰Shatin, Hong Kong
Semmelweis University, Cardiovascular Center
🇭🇺Budapest, Hungary
Allami Egeszsegugyi Kozpont (AEK) Hospital
🇭🇺Budapest, Hungary
Soroka MC
🇮🇱Beer Sheva, Israel
Carmel Medical Center
🇮🇱Haifa, Israel
Hadassh University Hospital, Mount Scopus
🇮🇱Jerusalem, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Institut Jantung Negara
🇲🇾Kuala Lumpur, Malaysia
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Medisch Centrum Haaglanden (MCH) - locatie Westeinde
🇳🇱Den Haag, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Universitair Medisch Centrum
🇳🇱Utrecht, Netherlands
Isala Klinieken
🇳🇱Zwolle, Netherlands
Sorlandet Sykehus HF Kristiansand
🇳🇴Kristiansand, Norway
Gornoslaskie Centrum Medyczne
🇵🇱Katowice, Poland
Polsko-Amerykańske Kliniki Serca
🇵🇱Tychy, Poland
Clinica Universitaria de Navarra
🇪🇸Pamplona, Spain
Saarland University Hospital
🇩🇪Homburg/Saar, Germany
Heart Center
🇩🇪Bernau, Germany