CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Dual Chamber ICD +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00787800
NCT00787800Phase 4Completed
CompareCT.gov

Reduction And Prevention of Tachyarrhythmias and Shocks Using Reduced Ventricular Pacing With Atrial Algorithms (The RAPTURE Study)

Mayo Clinic·interventional·Posted Nov 10, 2008·Updated Jul 24, 2014

In Brief

A Phase 4 clinical trial evaluating Dual Chamber ICD and Single Chamber ICD for Ventricular Tachycardia and 3 related conditions. Completed, enrolled 100 participants across 4 sites in 2 countries.

Detailed Summary

The RAPTURE Study will determine whether dual chamber defibrillators with atrial prevention and termination therapies, minimized ventricular pacing, and remote monitoring will reduce the rate of inappropriate shocks and improve quality of life compared to optimally programmed back-up pacing only single chamber ICDs when used for primary prevention of sudden cardiac death

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVentricular Tachycardia, Ventricular Fibrillation, Atrial Fibrillation, Supraventricular Tachycardia
CountriesIsrael, United States
CollaboratorsMedtronic

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2008
Enrollment StartNov 1, 2008
Primary CompletionDec 1, 2010
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.6 years ago

Interventions

Dual Chamber ICDdevice

Dual Chamber ICD: Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation Dual Chamber ICD Atrial prevention and termination therapies, Managed Ventricular Pacing (MVP)along with VT/VF detection and therapies for dual chamber device.

Single Chamber ICDdevice

Single Chamber: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements. VT/VF detection and therapies with discrimination criteria for single chamber device.