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Shockless Implant Evaluation (SIMPLE)

Primary Purpose

Ventricular Fibrillation, Ventricular Tachycardia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implantable defibrillator
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ventricular Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Royal Melbourne Hospital
  • Landesklinikum St. Poelten
  • Allgemeines Krankenhaus Wien
  • Wilhelminenspital
  • Klinikum Wels - Grieskirchen
  • University of Alberta Hospital
  • Royal Jubilee Hospital
  • St. Boniface General Hospital
  • Queen Elizabeth II Health Sciences Center
  • Hamilton General Hospital
  • Kingston General Hospital
  • London Health Sciences Centre
  • Ottawa Heart Institute
  • Sunnybrook & Women's College Health Sciences Centre
  • St. Michael's Hospital
  • Institut de Cardiologie de Montreal
  • Institut universitaire de Cardiologie et de Pneumologie de Quebec
  • Fleurimont Hospital
  • IKEM - Institut klinicke a experimentalni mediciny
  • Tampere University Hospital
  • CHU Grenoble - Hopital Michallon
  • CHRU de Lille
  • CHRU Nancy Brabois
  • CHG de Pau
  • CHRU Hopital Pontchaillou
  • Zentralklinik Bad Berka
  • German Heart Center Berlin
  • Heart Center
  • Evangelisches Krankenhaus Bielefeld
  • University Hospital Bochum Bergmannsheil
  • Klinikum Coburg gGmbH
  • Klinikum Lippe-Detmold
  • Klinikum Dortmund gGmbH
  • University Hospital
  • University Hospital Heidelberg
  • Saarland University Hospital
  • Klinikum Kassel
  • Krankenhaus Landshut Achdorf
  • Medizinische Klinik und Poliklinik I
  • Marienhospital Lünen
  • University Hospital of Muenster
  • Klinikum Nuernberg Sued
  • Klinikum Oldenburg GmbH
  • Klinikum Ernst von Bergmann gGmbH
  • Klinikum der Universitaet Regensburg
  • University of Rostock
  • Herzkreislaufzentrum Rotenburg
  • Krankenhaus der Barmherzigen Brüder
  • University Hospital Tübingen
  • University Hospital Ulm
  • Heinrich Braun Krankenhaus
  • Prince of Wales Hospital
  • Hungarian Institute of Cardiology
  • Semmelweis University, Cardiovascular Center
  • Allami Egeszsegugyi Kozpont (AEK) Hospital
  • Soroka MC
  • Carmel Medical Center
  • Hadassh University Hospital, Mount Scopus
  • Beilinson Medical Center
  • Tel Aviv Sourasky Medical Center
  • Sheba Medical Center
  • Institut Jantung Negara
  • Amphia Ziekenhuis
  • Medisch Centrum Haaglanden (MCH) - locatie Westeinde
  • Catharina Ziekenhuis
  • Leiden University Medical Center
  • Universitair Medisch Centrum
  • Isala Klinieken
  • Sorlandet Sykehus HF Kristiansand
  • Gornoslaskie Centrum Medyczne
  • Polsko-Amerykańske Kliniki Serca
  • Hospital De La Santa Creu I Sant Pau
  • Hospital Clinico Y Provincial
  • Hospital Universitario Gregorio Maranon
  • Hospital Clinico San Carlos
  • Hospital 12 de Octubre Madrid
  • Hospital La Paz
  • Clinica Universitaria de Navarra
  • Hospital De Navarra
  • H. Clinico Universitario
  • Karolinska Hospital
  • Ramathibodi Hospital
  • St. Peters Hospital
  • Cardiothoracic Centre
  • Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

ICD implant without defibrillation testing

ICD implant with defibrillation testing

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Perioperative Complication Rate
A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.

Full Information

First Posted
November 27, 2008
Last Updated
March 28, 2018
Sponsor
Boston Scientific Corporation
Collaborators
Guidant Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00800384
Brief Title
Shockless Implant Evaluation
Acronym
SIMPLE
Official Title
Shockless Implant Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
Collaborators
Guidant Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Fibrillation, Ventricular Tachycardia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ICD implant without defibrillation testing
Arm Title
2
Arm Type
Active Comparator
Arm Description
ICD implant with defibrillation testing
Intervention Type
Device
Intervention Name(s)
Implantable defibrillator
Other Intervention Name(s)
Study is not device specific., Any market released ICD including cardiac resynchromization therapy (CRT)-Ds can be included.
Intervention Description
Implantable defibrillator to detect and terminate ventricular arrhythmias
Primary Outcome Measure Information:
Title
First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death
Description
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.
Time Frame
Mean follow-up of 3.1 years
Secondary Outcome Measure Information:
Title
Perioperative Complication Rate
Description
A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Healey, MD
Organizational Affiliation
Population Health Research Institute Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stuart Connolly, MD
Organizational Affiliation
Population Health Research Institute Canada
Official's Role
Study Chair
Facility Information:
Facility Name
The Royal Melbourne Hospital
City
Melbourne
ZIP/Postal Code
3050
Country
Australia
Facility Name
Landesklinikum St. Poelten
City
St. Poelten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Allgemeines Krankenhaus Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Wilhelminenspital
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
Klinikum Wels - Grieskirchen
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Royal Jubilee Hospital
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L2V7
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Sunnybrook & Women's College Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Institut de Cardiologie de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Institut universitaire de Cardiologie et de Pneumologie de Quebec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Fleurimont Hospital
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
IKEM - Institut klinicke a experimentalni mediciny
City
Prague
ZIP/Postal Code
14021
Country
Czechia
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
CHU Grenoble - Hopital Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHRU Nancy Brabois
City
Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
CHG de Pau
City
Pau
ZIP/Postal Code
64046
Country
France
Facility Name
CHRU Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Zentralklinik Bad Berka
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
German Heart Center Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Heart Center
City
Bernau
ZIP/Postal Code
16321
Country
Germany
Facility Name
Evangelisches Krankenhaus Bielefeld
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Facility Name
University Hospital Bochum Bergmannsheil
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Klinikum Coburg gGmbH
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Klinikum Lippe-Detmold
City
Detmold
ZIP/Postal Code
32756
Country
Germany
Facility Name
Klinikum Dortmund gGmbH
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
University Hospital
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Saarland University Hospital
City
Homburg/Saar
ZIP/Postal Code
66424
Country
Germany
Facility Name
Klinikum Kassel
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Krankenhaus Landshut Achdorf
City
Landshut
ZIP/Postal Code
84036
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik I
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Marienhospital Lünen
City
Lünen
ZIP/Postal Code
44534
Country
Germany
Facility Name
University Hospital of Muenster
City
Muenster
ZIP/Postal Code
48129
Country
Germany
Facility Name
Klinikum Nuernberg Sued
City
Nuernberg
ZIP/Postal Code
90471
Country
Germany
Facility Name
Klinikum Oldenburg GmbH
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Klinikum Ernst von Bergmann gGmbH
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Klinikum der Universitaet Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
University of Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Herzkreislaufzentrum Rotenburg
City
Rotenburg an der Fulda
ZIP/Postal Code
36199
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
University Hospital Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
University Hospital Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Heinrich Braun Krankenhaus
City
Zwickau
ZIP/Postal Code
08060
Country
Germany
Facility Name
Prince of Wales Hospital
City
Shatin
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Hungarian Institute of Cardiology
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Semmelweis University, Cardiovascular Center
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Allami Egeszsegugyi Kozpont (AEK) Hospital
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Soroka MC
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Hadassh University Hospital, Mount Scopus
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel
Facility Name
Beilinson Medical Center
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Institut Jantung Negara
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Medisch Centrum Haaglanden (MCH) - locatie Westeinde
City
Den Haag
ZIP/Postal Code
2512 VA
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Universitair Medisch Centrum
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8000 GM
Country
Netherlands
Facility Name
Sorlandet Sykehus HF Kristiansand
City
Kristiansand
ZIP/Postal Code
4004
Country
Norway
Facility Name
Gornoslaskie Centrum Medyczne
City
Katowice
ZIP/Postal Code
40 635
Country
Poland
Facility Name
Polsko-Amerykańske Kliniki Serca
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Hospital De La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinico Y Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre Madrid
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital De Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
H. Clinico Universitario
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Karolinska Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
St. Peters Hospital
City
Chertsey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
Facility Name
Cardiothoracic Centre
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle-upon-Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29157723
Citation
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.
Results Reference
derived
PubMed Identifier
26569461
Citation
Vamos 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.
Results Reference
derived
PubMed Identifier
25715991
Citation
Healey 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.
Results Reference
derived

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Shockless Implant Evaluation

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