MedTrace Logo

The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock

NCT00787800 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-07-24

Study results available
· View outcomes & findings →

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

Conditions

  • Ventricular Tachycardia
  • Ventricular Fibrillation
  • Atrial Fibrillation
  • Supraventricular Tachycardia

Interventions

DEVICE

Dual Chamber ICD

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.

DEVICE

Single Chamber ICD

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.

Sponsors & Collaborators

Principal Investigators

  • Paul A Friedman, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-12-31
Completion
2011-12-31

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00787800 on ClinicalTrials.gov