Shockless Implant Evaluation
SIMPLE
1 other identifier
interventional
2,500
17 countries
84
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2008
CompletedFirst Posted
Study publicly available on registry
December 2, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
December 22, 2015
CompletedMarch 30, 2018
March 1, 2014
4.8 years
November 27, 2008
October 13, 2015
March 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Perioperative Complication Rate
30 days
Study Arms (2)
1
EXPERIMENTALICD implant without defibrillation testing
2
ACTIVE COMPARATORICD implant with defibrillation testing
Interventions
Implantable defibrillator to detect and terminate ventricular arrhythmias
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Patients undergoing initial implant of an ICD or CRT-D device (can be upgrade from a pacemaker)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Scientific Corporationlead
- Guidant Corporationcollaborator
Study Sites (85)
The Royal Melbourne Hospital
Melbourne, 3050, Australia
Landesklinikum St. Poelten
Sankt Pölten, 3100, Austria
Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
Wilhelminenspital
Vienna, 1160, Austria
Klinikum Wels - Grieskirchen
Wels, 4600, Austria
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Royal Jubilee Hospital
Victoria, British Columbia, V8R 1J8, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 3A7, Canada
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
Kingston General Hospital
Kingston, Ontario, K7L2V7, Canada
London Health Sciences Centre
London, Ontario, N6A 4G5, Canada
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8, Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V 4G5, Canada
Fleurimont Hospital
Sherbrooke, Quebec, J1H 5N4, Canada
IKEM - Institut klinicke a experimentalni mediciny
Prague, 14021, Czechia
Tampere University Hospital
Tampere, 33521, Finland
CHU Grenoble - Hopital Michallon
Grenoble, 38043, France
CHRU de Lille
Lille, 59037, France
CHRU Nancy Brabois
Nancy, 54500, France
CHG de Pau
Pau, 64046, France
CHRU Hopital Pontchaillou
Rennes, 35033, France
Zentralklinik Bad Berka
Bad Berka, 99437, Germany
German Heart Center Berlin
Berlin, 13353, Germany
Heart Center
Bernau, 16321, Germany
Evangelisches Krankenhaus Bielefeld
Bielefeld, 33617, Germany
University Hospital Bochum Bergmannsheil
Bochum, 44789, Germany
Klinikum Coburg gGmbH
Coburg, 96450, Germany
Klinikum Lippe-Detmold
Detmold, 32756, Germany
Klinikum Dortmund gGmbH
Dortmund, 44137, Germany
University Hospital
Frankfurt, 60590, Germany
University Hospital Heidelberg
Heidelberg, 69120, Germany
Saarland University Hospital
Homburg/Saar, 66424, Germany
Klinikum Kassel
Kassel, 34125, Germany
Krankenhaus Landshut Achdorf
Landshut, 84036, Germany
Medizinische Klinik und Poliklinik I
Leipzig, 04103, Germany
Marienhospital Lünen
Lünen, 44534, Germany
University Hospital of Muenster
Münster, 48129, Germany
Klinikum Nuernberg Sued
Nuremberg, 90471, Germany
Klinikum Oldenburg GmbH
Oldenburg, 26133, Germany
Klinikum Ernst von Bergmann gGmbH
Potsdam, 14467, Germany
Klinikum der Universitaet Regensburg
Regensburg, 93053, Germany
University of Rostock
Rostock, 18057, Germany
Herzkreislaufzentrum Rotenburg
Rotenburg an der Fulda, 36199, Germany
Krankenhaus der Barmherzigen Brüder
Trier, 54292, Germany
University Hospital Tübingen
Tübingen, 72076, Germany
University Hospital Ulm
Ulm, 89081, Germany
Heinrich Braun Krankenhaus
Zwickau, 08060, Germany
Prince of Wales Hospital
Shatin, 999077, Hong Kong
Hungarian Institute of Cardiology
Budapest, 1096, Hungary
Semmelweis University, Cardiovascular Center
Budapest, 1122, Hungary
Allami Egeszsegugyi Kozpont (AEK) Hospital
Budapest, 1134, Hungary
Soroka MC
Beersheba, 84101, Israel
Carmel Medical Center
Haifa, 34362, Israel
Hadassh University Hospital, Mount Scopus
Jerusalem, 91240, Israel
Beilinson Medical Center
Petah Tikva, 49100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Sheba Medical Center
Tel Litwinsky, 52621, Israel
Institut Jantung Negara
Kuala Lumpur, 50400, Malaysia
Amphia Ziekenhuis
Breda, 4818 CK, Netherlands
Catharina Ziekenhuis
Eindhoven, 5623 EJ, Netherlands
Leiden University Medical Center
Leiden, 2333 ZA, Netherlands
Medisch Centrum Haaglanden (MCH) - locatie Westeinde
The Hague, 2512 VA, Netherlands
Universitair Medisch Centrum
Utrecht, 3584 CX, Netherlands
Isala Klinieken
Zwolle, 8000 GM, Netherlands
Sorlandet Sykehus HF Kristiansand
Kristiansand, 4004, Norway
Gornoslaskie Centrum Medyczne
Katowice, 40 635, Poland
Polsko-Amerykańske Kliniki Serca
Tychy, 43-100, Poland
Hospital De La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hospital Clinico Y Provincial
Barcelona, 08036, Spain
Hospital Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital 12 de Octubre Madrid
Madrid, 28041, Spain
Hospital La Paz
Madrid, 28046, Spain
Clinica Universitaria de Navarra
Pamplona, 31008, Spain
Hospital De Navarra
Pamplona, 31008, Spain
H. Clinico Universitario
Valencia, 46010, Spain
Karolinska Hospital
Stockholm, 17176, Sweden
Ramathibodi Hospital
Bangkok, 10400, Thailand
St. Peters Hospital
Chertsey, KT16 0PZ, United Kingdom
Cardiothoracic Centre
Liverpool, L14 3PE, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Publications (3)
Vamos M, Healey JS, Wang J, Connolly SJ, Mabo P, Van Erven L, Kautzner J, Glikson M, Neuzner J, O'Hara G, Vinolas X, Gadler F, Hohnloser SH. Implantable cardioverter-defibrillator therapy in hypertrophic cardiomyopathy: A SIMPLE substudy. Heart Rhythm. 2018 Mar;15(3):386-392. doi: 10.1016/j.hrthm.2017.11.020. Epub 2017 Nov 20.
PMID: 29157723DERIVEDVamos M, Healey JS, Wang J, Duray GZ, Connolly SJ, van Erven L, Vinolas X, Neuzner J, Glikson M, Hohnloser SH. Troponin levels after ICD implantation with and without defibrillation testing and their predictive value for outcomes: Insights from the SIMPLE trial. Heart Rhythm. 2016 Feb;13(2):504-10. doi: 10.1016/j.hrthm.2015.11.009. Epub 2015 Nov 11.
PMID: 26569461DERIVEDHealey JS, Hohnloser SH, Glikson M, Neuzner J, Mabo P, Vinolas X, Kautzner J, O'Hara G, VanErven L, Gadler F, Pogue J, Appl U, Gilkerson J, Pochet T, Stein KM, Merkely B, Chrolavicius S, Meeks B, Foldesi C, Thibault B, Connolly SJ; Shockless IMPLant Evaluation [SIMPLE] investigators. Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE). Lancet. 2015 Feb 28;385(9970):785-91. doi: 10.1016/S0140-6736(14)61903-6. Epub 2015 Feb 23.
PMID: 25715991DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jeff Healey
- Organization
- Population Health Research Institute, McMaster University
Study Officials
- PRINCIPAL INVESTIGATOR
Jeff Healey, MD
Population Health Research Institute Canada
- STUDY CHAIR
Stuart Connolly, MD
Population Health Research Institute Canada
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2008
First Posted
December 2, 2008
Study Start
January 1, 2009
Primary Completion
October 1, 2013
Study Completion
May 1, 2014
Last Updated
March 30, 2018
Results First Posted
December 22, 2015
Record last verified: 2014-03