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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
NA
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00800384