AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-07-31

Brief Summary

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The purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with recurrent and symptomatic atrial fibrillation (AF).

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Detailed Description

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Epidemiologic studies have shown that 70-80% of patients with atrial fibrillation are older than 65 years of age. Drug therapy for atrial fibrillation is not effective or not tolerated in many elderly patients, for both rate or rhythm strategies. Preliminary data from AVN ablation and pacemaker therapy demonstrated this strategy is highly effective in controlling symptoms among patients who have failed numerous drug therapy. Quality of life is improved while hospital admission and office visits are reduced.

Pilot Study Design

* All patients will be 1:1 randomized to standard-care drug therapy (American College of Cardiology/American Heart Association Guideline, 2006) or AV node ablation and pacemaker therapy
* For patients randomized to AVN ablation, there will be a 1:1 sub-randomization to conventional right ventricular apex pacing or cardiac resynchronization therapy (biventricular pacing)
* All patients will be followed at 2 and 6 months from the time of randomization in the pilot study.
* A total of 60 patients from 5-15 clinical sites will be enrolled during an active recruiting period of 12 months for the pilot study.

Conditions

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Atrial Fibrillation Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug Therapy

FDA approved rate and rhythm control drugs

Group Type ACTIVE_COMPARATOR

FDA approved rate and rhythm control drugs

Intervention Type DRUG

Any approved rate or rhythm control drugs for treatment of atrial fibrillation may be prescribed under the primary physician's discretion.

Rate Control:

Beta-Blocker:

* metoprolol
* atenolol
* carvedilol

Calcium Channel Blocker:

* verapamil
* diltiazem

Rhythm Control:

* procainamide
* quinidine
* disopyramide
* propafenone
* flecainide
* sotalol
* dofetilide
* amiodarone

Atrioventricular Node (AVN) Ablation / Pacing

AV Node ablation and device implant

Group Type ACTIVE_COMPARATOR

AV Node ablation and device implant

Intervention Type DEVICE

Pacing Systems:

* Enpusle Premarket Approval Number (PMA#) P980035
* EnRhythm PMA# P980035
* Adapta PMA# P980035

Cardiac Resynchronization Therapy (CRT) Pacing Systems:

\- InSync III/ Insync Maximo/InSyncII Marquis PMA# P010031

Implantable Cardioverter-Defibrillator (ICD) Pacing Systems:

* EnTrust PMA# P980016
* Virtuoso PMA# P980016

ICD CRT Pacing Systems:

* InSync Maximo PMA# P980016
* InSync Sentry PMA# P890003
* Concerto PMA# P980016

Interventions

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FDA approved rate and rhythm control drugs

Any approved rate or rhythm control drugs for treatment of atrial fibrillation may be prescribed under the primary physician's discretion.

Rate Control:

Beta-Blocker:

* metoprolol
* atenolol
* carvedilol

Calcium Channel Blocker:

* verapamil
* diltiazem

Rhythm Control:

* procainamide
* quinidine
* disopyramide
* propafenone
* flecainide
* sotalol
* dofetilide
* amiodarone

Intervention Type DRUG

AV Node ablation and device implant

Pacing Systems:

* Enpusle Premarket Approval Number (PMA#) P980035
* EnRhythm PMA# P980035
* Adapta PMA# P980035

Cardiac Resynchronization Therapy (CRT) Pacing Systems:

\- InSync III/ Insync Maximo/InSyncII Marquis PMA# P010031

Implantable Cardioverter-Defibrillator (ICD) Pacing Systems:

* EnTrust PMA# P980016
* Virtuoso PMA# P980016

ICD CRT Pacing Systems:

* InSync Maximo PMA# P980016
* InSync Sentry PMA# P890003
* Concerto PMA# P980016

Intervention Type DEVICE

Other Intervention Names

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Lopressor Toprol XL Tenormin Coreg Isoptin Verelan Verelan PM Calan Bosoptin Covera-HS Cardizem Pronestyl Norpace Rythmol Betapace Tikosyn Cordarone Pacerone

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to 65 years
* Paroxysmal, persistent, or permanent atrial fibrillation
* Index event of atrial fibrillation is documented on electrocardiogram or rhythm strip. Atrial fibrillation must be the qualifying event. Atrial flutter can have been present in the past, but it must not be considered the index arrhythmia.
* Paroxysmal atrial fibrillation episodes must be recurrent (two or more episodes in the past 6 months). At least one of the paroxysmal episodes must be "sustained", defined as lasting greater than 1 hour documented by a Holter monitor or by history in conjunction with an ECG or a rhythm strip.
* At least one attempt of unsuccessful drug therapy, either for rate, for rhythm, or for rate-and-rhythm control.
* Symptoms related to atrial fibrillation within the last 6 months
* Eligible for long-term treatment with both treatment strategies
* Must provide informed consent, Health Insurance Portability and Accountability Act (HIPAA) authorization, and be willing to comply with follow-up requirements.

Exclusion Criteria

* Reversible causes of atrial fibrillation
* On heart transplant list
* Familial cardiac conditions with increased risk of sudden death
* Asymptomatic
* Medical condition limiting expected survival to be less than one year
* Contraindications to anticoagulation
* Pre-existing implanted pacemaker, implantable automatic cardioverter-defibrillator or cardiac resynchronization device.
* Pre-existing indication for permanent pacemaker, implantable automatic cardioverter-defibrillator or cardiac resynchronization device
* More than one attempt of drug therapy for rate, for rhythm, or for rate-and-rhythm control
* Planned major surgery within the next six months, including thoracic surgery
* Disability that would preclude collection of study data or have co-morbidity that would contraindicate device implantation
* Participated in another clinical trial within the previous 30 days using a therapeutic modality which could have potential residual effects that might confound the results of this pilot study
* Unable to provide informed consent

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No