Shockless Implant Evaluation

Study Overview
=================
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.

Official Title
-----------------
Shockless Implant Evaluation

Conditions
-----------------
Ventricular Fibrillation, Ventricular Tachycardia

Intervention / Treatment
-----------------
* Device: Implantable defibrillator


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ICD implant without defibrillation testing | Device: Implantable defibrillator<br>* Implantable defibrillator to detect and terminate ventricular arrhythmias<br>* Other names: Any market released ICD including cardiac resynchromization therapy (CRT)-Ds can be included.;|
| Active Comparator: 2<br>ICD implant with defibrillation testing | Device: Implantable defibrillator<br>* Implantable defibrillator to detect and terminate ventricular arrhythmias<br>* Other names: Any market released ICD including cardiac resynchromization therapy (CRT)-Ds can be included.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Mean follow-up of 3.1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Complication Rate | A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups. | 30 days |