Shockless Implant Evaluation

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.

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Key information

Conditions

Ventricular Fibrillation Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Melbourne Hospital, Melbourne, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable defibrillator

Device

Implantable defibrillator to detect and terminate ventricular arrhythmias

Other names: Study is not device specific., Any market released ICD including cardiac resynchromization therapy (CRT)-Ds can be included.

Primary outcomes

First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death

Time frame: 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 outcomes

Perioperative Complication Rate

Time frame: 30 days

A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

Guidant Corporation

Registry information

Acronym: SIMPLE

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2014
First posted: Dec 2, 2008
Registry last updated: Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed