AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study (PACIFIC)

Mayo Clinic

Status and phase

Terminated

Phase 3

Conditions

Atrial Fibrillation

Heart Failure

Treatments

Device: AV Node ablation and device implant

Drug: FDA approved rate and rhythm control drugs

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00589303

06-004554

Details and patient eligibility

About

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).

Full description

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.

Enrollment

27 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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