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

Primary Purpose

Ventricular Tachycardia, Ventricular Fibrillation, Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Dual Chamber ICD
Single Chamber ICD
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Shock prevention, Single vs. Dual Chamber, Reduce ventricular pacing, Atrial Fibrillation, Remote Monitoring, ICD, Implantable Cardioverter Defibrillator

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo Clinic
  • Mayo Clinic
  • Carmel Medical Center
  • Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dual Chamber ICD

Single Chamber ICD

Arm Description

Dual 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.

Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) detection and therapies will be programmed on including use of detection enhancements.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Number of Appropriate Shocks by ICD
Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.
Total Cost of ICD Implantation Procedure
Number of Subjects With Newly Detected Atrial Tachyarrhythmias
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.

Full Information

First Posted
November 6, 2008
Last Updated
July 2, 2014
Sponsor
Mayo Clinic
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00787800
Brief Title
The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock
Acronym
RAPTURE
Official Title
Reduction And Prevention of Tachyarrhythmias and Shocks Using Reduced Ventricular Pacing With Atrial Algorithms (The RAPTURE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Ventricular Fibrillation, Atrial Fibrillation, Supraventricular Tachycardia
Keywords
Shock prevention, Single vs. Dual Chamber, Reduce ventricular pacing, Atrial Fibrillation, Remote Monitoring, ICD, Implantable Cardioverter Defibrillator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual Chamber ICD
Arm Type
Active Comparator
Arm Description
Dual 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.
Arm Title
Single Chamber ICD
Arm Type
Active Comparator
Arm Description
Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) detection and therapies will be programmed on including use of detection enhancements.
Intervention Type
Device
Intervention Name(s)
Dual Chamber ICD
Other Intervention Name(s)
Virtuoso DR D154AWG
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Single Chamber ICD
Other Intervention Name(s)
Virtuoso VR D154VWC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)
Description
An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation).
Time Frame
Baseline to 12 months after ICD implantation
Secondary Outcome Measure Information:
Title
Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes
Description
Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes.
Time Frame
Baseline to 12 Months
Title
Number of Appropriate Shocks by ICD
Description
Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.
Time Frame
Baseline to 12 Months
Title
Total Cost of ICD Implantation Procedure
Time Frame
Baseline
Title
Number of Subjects With Newly Detected Atrial Tachyarrhythmias
Time Frame
Baseline to 12 months after ICD implantation
Title
Atrial Fibrillation (AF) Burden
Description
AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value.
Time Frame
Implantation through 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Friedman, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
11232608
Citation
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.
Results Reference
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PubMed Identifier
16769912
Citation
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.
Results Reference
background
PubMed Identifier
17445918
Citation
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.
Results Reference
background
PubMed Identifier
17804844
Citation
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.
Results Reference
background
PubMed Identifier
24928948
Citation
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.
Results Reference
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Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

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

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