Skip to main content
OpenTrials
Completed

NCT Number: NCT00787800

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Carmel Medical Center, Haifa, Israel

Loading trial locations.

About this study

While implantable cardioverter-defibrillator (ICD) therapy has become the gold standard for sudden death prevention in high risk individuals, reduction of device associated morbidity remains a significant problem. Rapidly conducted atrial tachyarrhythmias inappropriately detected as ventricular tachycardia (VT) are the most common cause for inappropriate shocks in ICD recipients, affecting 10 to 40% of patients. Large multicenter trials have shown modest benefits of atrial pacing in preventing atrial fibrillation, however right ventricular (RV) pacing was not limited, thus any favorable effects associated with atrial prevention and treatment may have been offset by the RV pacing. New algorithms to prevent RV pacing are now made available in our current devices. The choice of dual chamber versus single chamber ICD for primary prevention warrants re-assessment of atrial prevention and termination therapies, without the potentially adverse effects of RV pacing.

This Multi Center Pilot study will enroll 100 eligible subjects, 50 to single chamber and 50 to dual chamber ICDs. Patients will be followed for one year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Candidates for ICD for primary prevention according to American Heart Association/American College of Cardiology (AHA/ACC) guidelines who have a clinical indication for ICD implantation for ventricular arrhythmia or sudden death prevention.
  • The ability to understand the scope of the study, provide written informed consent, and a willingness to complete all study visits and associated procedures.

Exclusion criteria

  • Pregnant women
  • Age <18 years old
  • Inability to provide consent
  • On a heart transplant waiting list
  • Life expectancy <1 year
  • Indication for pacing
  • Atrioventricular (AV) node ablation
  • Permanent atrial fibrillation or atrial flutter
  • Indication for cardiac resynchronization
  • Preexisting, separate pacemaker pulse generator that won't be explanted
  • Intra-aortic balloon pump or other device
  • Inotropic drug (not digitalis) necessary for hemodynamic support
  • Chronic serious bacterial infection
  • Inability to receive pectoral non-thoracotomy lead ICD
  • Inability to program device according to protocol
  • History of Out of Hospital Cardiac Arrest (OHCA) or sustained Ventricular Tachycardia as an indication for ICD (secondary prevention indication)

Treatment and study plan

Dual Chamber ICD

Device

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.

Other names: Virtuoso DR D154AWG

Single Chamber ICD

Device

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.

Other names: Virtuoso VR D154VWC

Primary outcomes

  1. Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)

    Time frame: Baseline to 12 months after ICD implantation

    An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation).

Secondary outcomes

  1. Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes

    Time frame: Baseline to 12 Months

    Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes.

  2. Number of Appropriate Shocks by ICD

    Time frame: Baseline to 12 Months

    Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.

  3. Total Cost of ICD Implantation Procedure

    Time frame: Baseline

  4. Number of Subjects With Newly Detected Atrial Tachyarrhythmias

    Time frame: Baseline to 12 months after ICD implantation

  5. Atrial Fibrillation (AF) Burden

    Time frame: Implantation through 1 year

    AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: RAPTURE

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Nov 10, 2008
Registry last updated
Jul 24, 2014

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.

Related clinical trials

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