Shockless Implant Evaluation (SIMPLE)

March 28, 2018 updated by: Boston Scientific Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia, 3050
        • The Royal Melbourne Hospital
  • Austria
      • St. Poelten, Austria, 3100
        • Landesklinikum St. Poelten
      • Vienna, Austria, 1090
        • Allgemeines Krankenhaus Wien
      • Vienna, Austria, 1160
        • Wilhelminenspital
      • Wels, Austria, 4600
        • Klinikum Wels - Grieskirchen
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Royal Jubilee Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Queen Elizabeth II Health Sciences Center
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
      • Kingston, Ontario, Canada, K7L2V7
        • Kingston General Hospital
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Ottawa Heart Institute
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook & Women's College Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Institut de Cardiologie de Montreal
      • Québec, Quebec, Canada, G1V 4G5
        • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Fleurimont Hospital
  • Czechia
      • Prague, Czechia, 14021
        • IKEM - Institut klinicke a experimentalni mediciny
  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital
  • France
      • Grenoble, France, 38043
        • CHU Grenoble - Hôpital MICHALLON
      • Lille, France, 59037
        • CHRU de Lille
      • Nancy, France, 54500
        • Chru Nancy Brabois
      • Pau, France, 64046
        • CHG de Pau
      • Rennes, France, 35033
        • CHRU Hopital Pontchaillou
  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka
      • Berlin, Germany, 13353
        • German Heart Center Berlin
      • Bernau, Germany, 16321
        • Heart Center
      • Bielefeld, Germany, 33617
        • Evangelisches Krankenhaus Bielefeld
      • Bochum, Germany, 44789
        • University Hospital Bochum Bergmannsheil
      • Coburg, Germany, 96450
        • Klinikum Coburg gGmbH
      • Detmold, Germany, 32756
        • Klinikum Lippe-Detmold
      • Dortmund, Germany, 44137
        • Klinikum Dortmund gGmbH
      • Frankfurt, Germany, 60590
        • University Hospital
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg
      • Homburg/Saar, Germany, 66424
        • Saarland University Hospital
      • Kassel, Germany, 34125
        • Klinikum Kassel
      • Landshut, Germany, 84036
        • Krankenhaus Landshut Achdorf
      • Leipzig, Germany, 04103
        • Medizinische Klinik und Poliklinik I
      • Lünen, Germany, 44534
        • Marienhospital Lünen
      • Muenster, Germany, 48129
        • University Hospital of Muenster
      • Nuernberg, Germany, 90471
        • Klinikum Nuernberg Sued
      • Oldenburg, Germany, 26133
        • Klinikum Oldenburg GmbH
      • Potsdam, Germany, 14467
        • Klinikum Ernst von Bergmann gGmbH
      • Regensburg, Germany, 93053
        • Klinikum der Universitaet Regensburg
      • Rostock, Germany, 18057
        • University of Rostock
      • Rotenburg an der Fulda, Germany, 36199
        • Herzkreislaufzentrum Rotenburg
      • Trier, Germany, 54292
        • Krankenhaus der Barmherzigen Brüder
      • Tübingen, Germany, 72076
        • University Hospital Tübingen
      • Ulm, Germany, 89081
        • University Hospital Ulm
      • Zwickau, Germany, 08060
        • Heinrich Braun Krankenhaus
  • Hong Kong
      • Shatin, Hong Kong, 999077
        • Prince of Wales Hospital
  • Hungary
      • Budapest, Hungary, 1096
        • Hungarian Institute of Cardiology
      • Budapest, Hungary, 1122
        • Semmelweis University, Cardiovascular Center
      • Budapest, Hungary, 1134
        • Allami Egeszsegugyi Kozpont (AEK) Hospital
  • Israel
      • Beer Sheva, Israel, 84101
        • Soroka MC
      • Haifa, Israel, 34362
        • Carmel Medical Center
      • Jerusalem, Israel, 91240
        • Hadassh University Hospital, Mount Scopus
      • Petah-Tikva, Israel, 49100
        • Beilinson medical center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
      • Tel Hashomer, Israel, 52621
        • Sheba Medical Center
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Institut Jantung Negara
  • Netherlands
      • Breda, Netherlands, 4818 CK
        • Amphia Ziekenhuis
      • Den Haag, Netherlands, 2512 VA
        • Medisch Centrum Haaglanden (MCH) - locatie Westeinde
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Ziekenhuis
      • Leiden, Netherlands, 2333 ZA
        • Leiden University Medical Center
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum
      • Zwolle, Netherlands, 8000 GM
        • Isala Klinieken
  • Norway
      • Kristiansand, Norway, 4004
        • Sorlandet Sykehus HF Kristiansand
  • Poland
      • Katowice, Poland, 40 635
        • Gornoslaskie Centrum Medyczne
      • Tychy, Poland, 43-100
        • Polsko-Amerykańske Kliniki Serca
  • Spain
      • Barcelona, Spain, 08025
        • Hospital de La Santa Creu I Sant Pau
      • Barcelona, Spain, 08036
        • Hospital Clinico Y Provincial
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Marañón
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre Madrid
      • Pamplona, Spain, 31008
        • Hospital de Navarra
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra
      • Valencia, Spain, 46010
        • H. Clinico Universitario
  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska Hospital
  • Thailand
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
  • United Kingdom
      • Chertsey, United Kingdom, KT16 0PZ
        • St. Peters Hospital
      • Liverpool, United Kingdom, L14 3PE
        • Cardiothoracic Centre
      • Newcastle-upon-Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
ICD implant without defibrillation testing
Device: Implantable defibrillator
Implantable defibrillator to detect and terminate ventricular arrhythmias
Other Names:
  • Study is not device specific.
  • Any market released ICD including cardiac resynchromization therapy (CRT)-Ds can be included.
Active Comparator: 2
ICD implant with defibrillation testing
Device: Implantable defibrillator
Implantable defibrillator to detect and terminate ventricular arrhythmias
Other Names:
  • Study is not device specific.
  • Any market released ICD including cardiac resynchromization therapy (CRT)-Ds can be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death
Time Frame: 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.
Mean follow-up of 3.1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Complication Rate
Time Frame: 30 days
A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

Guidant Corporation

Investigators

  • Principal Investigator: Jeff Healey, MD, Population Health Research Institute Canada
  • Study Chair: Stuart Connolly, MD, Population Health Research Institute Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

November 27, 2008

First Submitted That Met QC Criteria

December 1, 2008

First Posted (Estimate)

December 2, 2008

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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