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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators

NCT01557842

Ventricular Tachycardia Ischemic

TERMINATED PHASE4

Ventricular Tachycardia Mechanisms

NCT05478213

Ventricular Tachycardia

RECRUITING NA

Substrate Modification in Stable Ventricular Tachycardia in Addition to Implantable Cardioverter Defibrillator (ICD) Therapy

NCT00919373

Ventricular Tachycardia Coronary Artery Disease Left Ventricular Dysfunction

COMPLETED NA

Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)

NCT04496518

Ventricular Tachycardia

ACTIVE_NOT_RECRUITING

Effects Rapid Atrial Pacing Has on the Electrocardiogram (ECG) in Patients With Dual Chamber Pacemakers

NCT00883610

Prolonged QT Interval

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventricular Tachycardia Ventricular Fibrillation Atrial Fibrillation Supraventricular Tachycardia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dual Chamber ICD

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.

Group Type ACTIVE_COMPARATOR

Dual Chamber ICD

Intervention Type 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.

Single Chamber ICD

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.

Group Type ACTIVE_COMPARATOR

Single Chamber ICD

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Virtuoso DR D154AWG Virtuoso VR D154VWC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No