Ventricular Tachycardia Clinical Trial
— SIMPLEOfficial title:
Shockless Implant Evaluation
Verified date | March 2014 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation | Guidant Corporation |
Australia, Austria, Canada, Czechia, Finland, France, Germany, Hong Kong, Hungary, Israel, Malaysia, Netherlands, Norway, Poland, Spain, Sweden, Thailand, United Kingdom,
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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