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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00800384




Registration number
NCT00800384
Ethics application status
Date submitted
27/11/2008
Date registered
2/12/2008
Date last updated
30/03/2018

Titles & IDs
Public title
Shockless Implant Evaluation
Scientific title
Shockless Implant Evaluation
Secondary ID [1] 0 0
11-2007
Universal Trial Number (UTN)
Trial acronym
SIMPLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventricular Fibrillation 0 0
Ventricular Tachycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Implantable defibrillator

Experimental: 1 - ICD implant without defibrillation testing

Active comparator: 2 - ICD implant with defibrillation testing


Treatment: Devices: Implantable defibrillator
Implantable defibrillator to detect and terminate ventricular arrhythmias
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death
Timepoint [1] 0 0
Mean follow-up of 3.1 years
Secondary outcome [1] 0 0
Perioperative Complication Rate
Timepoint [1] 0 0
30 days

Eligibility
Key inclusion criteria
* Age = 18 years
* Patients undergoing initial implant of an ICD or CRT-D device (can be upgrade from a pacemaker)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
Accrual to date
Final
2500
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
St. Poelten
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Austria
State/province [3] 0 0
Wels
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 0 0
Manitoba
Country [7] 0 0
Canada
State/province [7] 0 0
Nova Scotia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Czechia
State/province [10] 0 0
Prague
Country [11] 0 0
Finland
State/province [11] 0 0
Tampere
Country [12] 0 0
France
State/province [12] 0 0
Grenoble
Country [13] 0 0
France
State/province [13] 0 0
Lille
Country [14] 0 0
France
State/province [14] 0 0
Nancy
Country [15] 0 0
France
State/province [15] 0 0
Pau
Country [16] 0 0
France
State/province [16] 0 0
Rennes
Country [17] 0 0
Germany
State/province [17] 0 0
Bad Berka
Country [18] 0 0
Germany
State/province [18] 0 0
Berlin
Country [19] 0 0
Germany
State/province [19] 0 0
Bernau
Country [20] 0 0
Germany
State/province [20] 0 0
Bielefeld
Country [21] 0 0
Germany
State/province [21] 0 0
Bochum
Country [22] 0 0
Germany
State/province [22] 0 0
Coburg
Country [23] 0 0
Germany
State/province [23] 0 0
Detmold
Country [24] 0 0
Germany
State/province [24] 0 0
Dortmund
Country [25] 0 0
Germany
State/province [25] 0 0
Frankfurt
Country [26] 0 0
Germany
State/province [26] 0 0
Heidelberg
Country [27] 0 0
Germany
State/province [27] 0 0
Homburg/Saar
Country [28] 0 0
Germany
State/province [28] 0 0
Kassel
Country [29] 0 0
Germany
State/province [29] 0 0
Landshut
Country [30] 0 0
Germany
State/province [30] 0 0
Leipzig
Country [31] 0 0
Germany
State/province [31] 0 0
Lünen
Country [32] 0 0
Germany
State/province [32] 0 0
Muenster
Country [33] 0 0
Germany
State/province [33] 0 0
Nuernberg
Country [34] 0 0
Germany
State/province [34] 0 0
Oldenburg
Country [35] 0 0
Germany
State/province [35] 0 0
Potsdam
Country [36] 0 0
Germany
State/province [36] 0 0
Regensburg
Country [37] 0 0
Germany
State/province [37] 0 0
Rostock
Country [38] 0 0
Germany
State/province [38] 0 0
Rotenburg an der Fulda
Country [39] 0 0
Germany
State/province [39] 0 0
Trier
Country [40] 0 0
Germany
State/province [40] 0 0
Tübingen
Country [41] 0 0
Germany
State/province [41] 0 0
Ulm
Country [42] 0 0
Germany
State/province [42] 0 0
Zwickau
Country [43] 0 0
Hong Kong
State/province [43] 0 0
Shatin
Country [44] 0 0
Hungary
State/province [44] 0 0
Budapest
Country [45] 0 0
Israel
State/province [45] 0 0
Beer Sheva
Country [46] 0 0
Israel
State/province [46] 0 0
Haifa
Country [47] 0 0
Israel
State/province [47] 0 0
Jerusalem
Country [48] 0 0
Israel
State/province [48] 0 0
Petah-Tikva
Country [49] 0 0
Israel
State/province [49] 0 0
Tel Aviv
Country [50] 0 0
Israel
State/province [50] 0 0
Tel Hashomer
Country [51] 0 0
Malaysia
State/province [51] 0 0
Kuala Lumpur
Country [52] 0 0
Netherlands
State/province [52] 0 0
Breda
Country [53] 0 0
Netherlands
State/province [53] 0 0
Den Haag
Country [54] 0 0
Netherlands
State/province [54] 0 0
Eindhoven
Country [55] 0 0
Netherlands
State/province [55] 0 0
Leiden
Country [56] 0 0
Netherlands
State/province [56] 0 0
Utrecht
Country [57] 0 0
Netherlands
State/province [57] 0 0
Zwolle
Country [58] 0 0
Norway
State/province [58] 0 0
Kristiansand
Country [59] 0 0
Poland
State/province [59] 0 0
Katowice
Country [60] 0 0
Poland
State/province [60] 0 0
Tychy
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
Country [62] 0 0
Spain
State/province [62] 0 0
Madrid
Country [63] 0 0
Spain
State/province [63] 0 0
Pamplona
Country [64] 0 0
Spain
State/province [64] 0 0
Valencia
Country [65] 0 0
Sweden
State/province [65] 0 0
Stockholm
Country [66] 0 0
Thailand
State/province [66] 0 0
Bangkok
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Chertsey
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Liverpool
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Newcastle-upon-Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Guidant Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00800384
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Jeff Healey, MD
Address 0 0
Population Health Research Institute Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00800384