Clinical trial NCT00800384: Shockless Implant Evaluation
Official title: Shockless Implant Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Fibrillation
Ventricular Tachycardia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Guidant Corporation
First posted: 2008-12-02
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death
timeFrame: Mean follow-up of 3.1 years
Secondary outcomes:
measure: Perioperative Complication Rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
city: St. Poelten
country: Austria
facility: Landesklinikum St. Poelten
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus Wien
city: Vienna
country: Austria
facility: Wilhelminenspital
city: Wels
country: Austria
facility: Klinikum Wels - Grieskirchen
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook & Women's College Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal
state: Quebec
city: Québec
country: Canada
facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec
state: Quebec
city: Sherbrooke
country: Canada
facility: Fleurimont Hospital
state: Quebec
city: Prague
country: Czechia
facility: IKEM - Institut klinicke a experimentalni mediciny
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Grenoble
country: France
facility: CHU Grenoble - Hopital Michallon
city: Lille
country: France
facility: CHRU de Lille
city: Nancy
country: France
facility: CHRU Nancy Brabois
city: Pau
country: France
facility: CHG de Pau
city: Rennes
country: France
facility: CHRU Hopital Pontchaillou
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Berlin
country: Germany
facility: German Heart Center Berlin
city: Bernau
country: Germany
facility: Heart Center
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus Bielefeld
city: Bochum
country: Germany
facility: University Hospital Bochum Bergmannsheil
city: Coburg
country: Germany
facility: Klinikum Coburg gGmbH
city: Detmold
country: Germany
facility: Klinikum Lippe-Detmold
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH
city: Frankfurt
country: Germany
facility: University Hospital
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Homburg/Saar
country: Germany
facility: Saarland University Hospital
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Landshut
country: Germany
facility: Krankenhaus Landshut Achdorf
city: Leipzig
country: Germany
facility: Medizinische Klinik und Poliklinik I
city: Lünen
country: Germany
facility: Marienhospital Lünen
city: Muenster
country: Germany
facility: University Hospital of Muenster
city: Nuernberg
country: Germany
facility: Klinikum Nuernberg Sued
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg GmbH
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann gGmbH
city: Regensburg
country: Germany
facility: Klinikum der Universitaet Regensburg
city: Rostock
country: Germany
facility: University of Rostock
city: Rotenburg an der Fulda
country: Germany
facility: Herzkreislaufzentrum Rotenburg
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Tübingen
country: Germany
facility: University Hospital Tübingen
city: Ulm
country: Germany
facility: University Hospital Ulm
city: Zwickau
country: Germany
facility: Heinrich Braun Krankenhaus
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
city: Budapest
country: Hungary
facility: Hungarian Institute of Cardiology
city: Budapest
country: Hungary
facility: Semmelweis University, Cardiovascular Center
city: Budapest
country: Hungary
facility: Allami Egeszsegugyi Kozpont (AEK) Hospital
city: Beer Sheva
country: Israel
facility: Soroka MC
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Jerusalem
country: Israel
facility: Hadassh University Hospital, Mount Scopus
city: Petah-Tikva
country: Israel
facility: Beilinson Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Den Haag
country: Netherlands
facility: Medisch Centrum Haaglanden (MCH) - locatie Westeinde
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Kristiansand
country: Norway
facility: Sorlandet Sykehus HF Kristiansand
city: Katowice
country: Poland
facility: Gornoslaskie Centrum Medyczne
city: Tychy
country: Poland
facility: Polsko-Amerykańske Kliniki Serca
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinico Y Provincial
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital 12 de Octubre Madrid
city: Madrid
country: Spain
facility: Hospital La Paz
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Pamplona
country: Spain
facility: Hospital De Navarra
city: Valencia
country: Spain
facility: H. Clinico Universitario
city: Stockholm
country: Sweden
facility: Karolinska Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Chertsey
country: United Kingdom
facility: St. Peters Hospital
city: Liverpool
country: United Kingdom
facility: Cardiothoracic Centre
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: Population Health Research Institute Canada
name: Jeff Healey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute Canada
name: Stuart Connolly, MD
role: STUDY_CHAIR
References:
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.
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.
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.