completed

The objective of the SIMPLE trial was to test the hypothesis that use of an implantable cardioverter defibrillator (ICD) without induction of ventricular fibrillation is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death.

Primary endpoint:

First occurrence of the composite of failed first appropriate clinical shock from the ICD or arrhythmic death.

Secondary endpoint:

Complication rate. All outcome events are adjudicated.

Study Type

Interventional - Device

Study Design

Randomized, single blind (subject), active control, parallel group, non-inferiority

NO. of Countries

18

NO. of Sites

85

NO. of Participants

2500

Study Period

2009-2014

Sponsor

Boston Scientific

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