Shockless Implant Evaluation

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
2	Implantable defibrillator	ICD implant with defibrillation testing
1	Implantable defibrillator	ICD implant without defibrillation testing

Primary Outcome Measures

Name	Time	Method
First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death	Mean follow-up of 3.1 years	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

Name	Time	Method
Perioperative Complication Rate	30 days	A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.

Locations (85): The Royal Melbourne Hospital
🇦🇺
Melbourne, Australia
Landesklinikum St. Poelten
🇦🇹
St. Poelten, Austria
Allgemeines Krankenhaus Wien
🇦🇹
Vienna, Austria
Wilhelminenspital
🇦🇹
Vienna, Austria
Klinikum Wels - Grieskirchen
🇦🇹
Wels, Austria
University of Alberta Hospital
🇨🇦
Edmonton, Alberta, Canada
Royal Jubilee Hospital
🇨🇦
Victoria, British Columbia, Canada
St. Boniface General Hospital
🇨🇦
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Center
🇨🇦
Halifax, Nova Scotia, Canada
Hamilton General Hospital
🇨🇦
Hamilton, Ontario, Canada
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The Royal Melbourne Hospital
🇦🇺Melbourne, Australia