Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing atrioventricular (AV) node ablation and permanent pacing therapy.

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Detailed Description

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This study is a multi-center, prospective, randomized, blinded trial. The study will consist of approximately 265 patients who require treatment of persistent or permanent, symptomatic atrial fibrillation by atrioventricular (AV) node ablation and permanent pacing therapy i.e. "Ablate and Pace" therapy. All patients enrolled into the clinical study will be randomly assigned to one of three groups using a randomization ratio of 2:2:1. Patients will be assigned to receive either biventricular (biV) pacing with CLS-based rate adaptive pacing using the legally marketed Protos DR/CLS (Group 1), or biventricular pacing with accelerometer-based rate adaptive pacing using the Stratos LV (Group 2), or right ventricular (RV) pacing with accelerometer-based rate adaptive pacing using the Stratos LV (Group 3). Patients in all three groups will be implanted with legally marketed right and left ventricular pacing leads. The patients, the core lab used to interpret the echocardiographic data and the Clinical Events Committee adjudicating crossover, patient death and congestive heart failure (CHF) hospitalizations will be blinded to the randomization assignment.

Conditions

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Atrial Fibrillation Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)

Group Type ACTIVE_COMPARATOR

Protos DR/CLS and Stratos LV CRT pacemakers

Intervention Type DEVICE

Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption

2

Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)

Group Type ACTIVE_COMPARATOR

Protos DR/CLS and Stratos LV CRT pacemakers

Intervention Type DEVICE

Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption

3

Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)

Group Type ACTIVE_COMPARATOR

Protos DR/CLS and Stratos LV CRT pacemakers

Intervention Type DEVICE

Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption

Interventions

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Protos DR/CLS and Stratos LV CRT pacemakers

Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption

Intervention Type DEVICE

Other Intervention Names

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Protos DR/CLS dual chamber pacemaker

Eligibility Criteria

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Inclusion Criteria

* Meet the indications for therapy
* Persistent, symptomatic AF with poorly controlled rapid ventricular rates or permanent, symptomatic AF with poorly controlled rapid ventricular rates.
* Eligible for AV nodal ablation and permanent pacemaker implantation
* NYHA Class II or III heart failure
* Age ≥ 18 years
* Understand the nature of the procedure
* Ability to tolerate the surgical procedure required for implantation
* Give informed consent
* Able to complete all testing required by the clinical protocol
* Available for follow-up visits on a regular basis at the investigational site

Exclusion Criteria

* Meet one or more of the contraindications
* Have a life expectancy of less than six months
* Expected to receive heart transplantation within six months
* Enrolled in another cardiovascular or pharmacological clinical investigation
* Patients with an ICD, or being considered for an ICD
* Patients with previously implanted biventricular pacing systems
* Patients with previously implanted single or dual chamber pacing system with \> 50% documented ventricular pacing
* Patients with previous AV node ablation
* Six-minute walk test distance greater than 450 meters
* Any condition preventing the patient from being able to perform required testing
* Presence of another life-threatening, underlying illness separate from their cardiac disorder
* Conditions that prohibit placement of any of the lead systems

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No