Shockless Implant Evaluation (SIMPLE)

Boston Scientific

Status: Completed

Conditions: Ventricular Fibrillation; Ventricular Tachycardia

Treatments: Device: Implantable defibrillator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00800384

11-2007

Details and patient eligibility

About

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.

Enrollment: 2,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

2,500 participants in 2 patient groups

1

Experimental group

Description:

ICD implant without defibrillation testing

Treatment:

Device: Implantable defibrillator

2

Active Comparator group

Description:

ICD implant with defibrillation testing

Treatment:

Device: Implantable defibrillator