Shockless Implant Evaluation

Ventricular Tachycardia Clinical Trial

— SIMPLE  

Official title:

Shockless Implant Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800384
• Other study ID #: 11-2007
• 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
• 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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

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