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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00800384
Other study ID # 11-2007
Secondary ID
Status Completed
Phase N/A
First received November 27, 2008
Last updated March 28, 2018
Start date January 2009
Est. completion date May 2014

Study information

Verified date March 2014
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 2500
Est. completion date May 2014
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age = 18 years

- Patients undergoing initial implant of an ICD or CRT-D device (can be upgrade from a pacemaker)

Exclusion Criteria:

- 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


Intervention

Device:
Implantable defibrillator
Implantable defibrillator to detect and terminate ventricular arrhythmias

Locations

Country Name City State
Australia The Royal Melbourne Hospital Melbourne
Austria Landesklinikum St. Poelten St. Poelten
Austria Allgemeines Krankenhaus Wien Vienna
Austria Wilhelminenspital Vienna
Austria Klinikum Wels - Grieskirchen Wels
Canada University of Alberta Hospital Edmonton Alberta
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 Institut de Cardiologie de Montreal Montreal Quebec
Canada Ottawa Heart Institute Ottawa Ontario
Canada Institut universitaire de Cardiologie et de Pneumologie de Quebec Québec Quebec
Canada Fleurimont Hospital Sherbrooke Quebec
Canada St. Michael's Hospital Toronto Ontario
Canada Sunnybrook & Women's College Health Sciences Centre Toronto Ontario
Canada Royal Jubilee Hospital Victoria British Columbia
Canada St. Boniface General Hospital Winnipeg Manitoba
Czechia IKEM - Institut klinicke a experimentalni mediciny Prague
Finland Tampere University Hospital Tampere
France CHU Grenoble - Hopital Michallon Grenoble
France CHRU de Lille Lille
France CHRU Nancy Brabois Nancy
France CHG de Pau Pau
France CHRU Hopital Pontchaillou Rennes
Germany Zentralklinik Bad Berka Bad Berka
Germany German Heart Center Berlin Berlin
Germany Heart Center Bernau
Germany Evangelisches Krankenhaus Bielefeld Bielefeld
Germany University Hospital Bochum Bergmannsheil Bochum
Germany Klinikum Coburg gGmbH Coburg
Germany Klinikum Lippe-Detmold Detmold
Germany Klinikum Dortmund gGmbH Dortmund
Germany University Hospital Frankfurt
Germany University Hospital Heidelberg Heidelberg
Germany Saarland University Hospital Homburg/Saar
Germany Klinikum Kassel Kassel
Germany Krankenhaus Landshut Achdorf Landshut
Germany Medizinische Klinik und Poliklinik I Leipzig
Germany Marienhospital Lünen Lünen
Germany University Hospital of Muenster Muenster
Germany Klinikum Nuernberg Sued Nuernberg
Germany Klinikum Oldenburg GmbH Oldenburg
Germany Klinikum Ernst von Bergmann gGmbH Potsdam
Germany Klinikum der Universitaet Regensburg Regensburg
Germany University of Rostock Rostock
Germany Herzkreislaufzentrum Rotenburg Rotenburg an der Fulda
Germany Krankenhaus der Barmherzigen Brüder Trier
Germany University Hospital Tübingen Tübingen
Germany University Hospital Ulm Ulm
Germany Heinrich Braun Krankenhaus Zwickau
Hong Kong Prince of Wales Hospital Shatin
Hungary Allami Egeszsegugyi Kozpont (AEK) Hospital Budapest
Hungary Hungarian Institute of Cardiology Budapest
Hungary Semmelweis University, Cardiovascular Center Budapest
Israel Soroka MC Beer Sheva
Israel Carmel Medical Center Haifa
Israel Hadassh University Hospital, Mount Scopus Jerusalem
Israel Beilinson Medical Center Petah-Tikva
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Israel Sheba Medical Center Tel Hashomer
Malaysia Institut Jantung Negara Kuala Lumpur
Netherlands 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
Norway Sorlandet Sykehus HF Kristiansand Kristiansand
Poland Gornoslaskie Centrum Medyczne Katowice
Poland Polsko-Amerykanske Kliniki Serca Tychy
Spain Hospital Clinico Y Provincial Barcelona
Spain Hospital De La Santa Creu I Sant Pau Barcelona
Spain Hospital 12 de Octubre Madrid Madrid
Spain Hospital Clinico San Carlos Madrid
Spain Hospital La Paz Madrid
Spain Hospital Universitario Gregorio Maranon Madrid
Spain Clinica Universitaria de Navarra Pamplona
Spain Hospital De Navarra Pamplona
Spain H. Clinico Universitario Valencia
Sweden Karolinska Hospital Stockholm
Thailand Ramathibodi Hospital Bangkok
United Kingdom St. Peters Hospital Chertsey
United Kingdom Cardiothoracic Centre Liverpool
United Kingdom Freeman Hospital Newcastle-upon-Tyne

Sponsors (2)

Lead Sponsor Collaborator
Boston Scientific Corporation Guidant Corporation

Countries where clinical trial is conducted

Australia,  Austria,  Canada,  Czechia,  Finland,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Malaysia,  Netherlands,  Norway,  Poland,  Spain,  Sweden,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death 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. Mean follow-up of 3.1 years
Secondary Perioperative Complication Rate A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups. 30 days
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