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Ventricular TachycardiaPhase 4RAPTURENCT00787800

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

A Phase 4 study testing Dual Chamber ICD and Single Chamber ICD in people with Ventricular Tachycardia and Ventricular Fibrillation, run by Mayo Clinic at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Dual Chamber ICD and Single Chamber ICD
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesin 2 countries
Study dates
Nov 2008to Dec 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Pregnant women
  • Age <18 years old
  • Inability to provide consent
  • On a heart transplant waiting list
  • Life expectancy <1 year
  • Indication for pacing
Show all 16Show fewer
  • 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)

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States2 sites

  • Mayo Clinic

    Jacksonville, Florida

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

Israel2 sites

  • Carmel Medical Center

    Haifa

  • Sheba Medical Center

    Ramat Gan

Other trials in Israel

About this study

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

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

Read the detailed description

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.

Being tested
Dual Chamber ICD, Single Chamber ICD
Keywords
Shock prevention, Single vs. Dual Chamber, Reduce ventricular pacing, Atrial Fibrillation, Remote Monitoring, ICD, Implantable Cardioverter Defibrillator
Medical subject headings
Tachycardia, Ventricular, Ventricular Fibrillation, Atrial Fibrillation, Tachycardia, Supraventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dual Chamber ICDDevice

    Also called Virtuoso DR D154AWG

    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

    Also called Virtuoso VR D154VWC

    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.

Study groups in NCT00787800
Study groupRoleWhat they receive
Dual Chamber ICDActive comparatorDual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
Receives: Device: Dual Chamber ICD
Single Chamber ICDActive comparatorSingle chamber Implantable Cardioverter-Defibrillator: Optimally programmed Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) detection and therapies will be programmed on including use of detection enhancements.
Receives: Device: Single Chamber ICD

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Baseline to 12 months after ICD implantation

Secondary outcomes (5)

  1. Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes

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

    Measured: Baseline to 12 Months

  2. Number of Appropriate Shocks by ICD

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

    Measured: Baseline to 12 Months

  3. Total Cost of ICD Implantation Procedure

    Measured: Baseline

  4. Number of Subjects With Newly Detected Atrial Tachyarrhythmias

    Measured: Baseline to 12 months after ICD implantation

  5. Atrial Fibrillation (AF) Burden

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

    Measured: Implantation through 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionDec 2010
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00787800
Sponsor's protocol ID
08-003618
Acronym
RAPTURE
Status last verified
Jul 2014
First submitted
6 Nov 2008
Last updated
24 Jul 2014
Data monitoring committee
No

Publications

  • Deisenhofer I, Kolb C, Ndrepepa G, Schreieck J, Karch M, Schmieder S, Zrenner B, Schmitt C. Do current dual chamber cardioverter defibrillators have advantages over conventional single chamber cardioverter defibrillators in reducing inappropriate therapies? A randomized, prospective study. J Cardiovasc Electrophysiol. 2001 Feb;12(2):134-42. doi: 10.1046/j.1540-8167.2001.00134.x.

    PubMed 11232608

  • Friedman PA, McClelland RL, Bamlet WR, Acosta H, Kessler D, Munger TM, Kavesh NG, Wood M, Daoud E, Massumi A, Schuger C, Shorofsky S, Wilkoff B, Glikson M. Dual-chamber versus single-chamber detection enhancements for implantable defibrillator rhythm diagnosis: the detect supraventricular tachycardia study. Circulation. 2006 Jun 27;113(25):2871-9. doi: 10.1161/CIRCULATIONAHA.105.594531. Epub 2006 Jun 12.

    PubMed 16769912

  • Theuns DA, Rivero-Ayerza M, Boersma E, Jordaens L. Prevention of inappropriate therapy in implantable defibrillators: A meta-analysis of clinical trials comparing single-chamber and dual-chamber arrhythmia discrimination algorithms. Int J Cardiol. 2008 Apr 25;125(3):352-7. doi: 10.1016/j.ijcard.2007.02.041. Epub 2007 Apr 18.

    PubMed 17445918

  • Sweeney MO, Bank AJ, Nsah E, Koullick M, Zeng QC, Hettrick D, Sheldon T, Lamas GA; Search AV Extension and Managed Ventricular Pacing for Promoting Atrioventricular Conduction (SAVE PACe) Trial. Minimizing ventricular pacing to reduce atrial fibrillation in sinus-node disease. N Engl J Med. 2007 Sep 6;357(10):1000-8. doi: 10.1056/NEJMoa071880.

    PubMed 17804844

  • Friedman PA, Bradley D, Koestler C, Slusser J, Hodge D, Bailey K, Kusumoto F, Munger TM, Militanu A, Glikson M. A prospective randomized trial of single- or dual-chamber implantable cardioverter-defibrillators to minimize inappropriate shock risk in primary sudden cardiac death prevention. Europace. 2014 Oct;16(10):1460-8. doi: 10.1093/europace/euu022. Epub 2014 Jun 13.

    PubMed 24928948

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dual Chamber ICD and Single Chamber ICD in people with Ventricular Tachycardia and Ventricular Fibrillation, run by Mayo Clinic at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD) (time frame: Baseline to 12 months after ICD implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00787800, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.

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