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Research

Photo for SIMPLE

SIMPLE

Official Title

Shockless Implant Evaluation

Status

Completed

Overview

To test the hypothesis that ICD implantation without defibrillation testing is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death.

Study Design

Randomized, single blind (subject), active control, parallel group design, supportive care.

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.

Number of Patients

2500

Number of Sites

85

Number of Countries

18

Study Period

2009–2013

Principal Investigator

Jeff Healey

Program Manager

Susan Chrolavicius, Brandi Meeks

Research Coordinator

Amanda Gilbert

Key Publications

SIMPLE – The Lancet

  • Healey JS, Hohnloser SH, Glikson M, Neuzner J, Viñolas X, Mabo P, Kautzner J, O’Hara G, Van Erven L, Gadler F, Appl U, Connolly SJ. The rationale and design of the Shockless IMPLant Evaluation (SIMPLE) trial: a randomized, controlled trial of defibrillation testing at the time of defibrillator implantation. Am Heart J. 2012 Aug;164(2):146-52. doi: 10.1016/j.ahj.2012.05.007.