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

Phase 3

Terminated

• Conditions: Atrial Fibrillation; Heart Failure
• Interventions: Drug: FDA approved rate and rhythm control drugs; Device: AV Node ablation and device implant

• Registration Number: NCT00589303
• Lead Sponsor: Mayo Clinic

Brief Summary

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).

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2008-01-07
• Study First Posted: 2008-01-09
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2013-02
• Results First Submitted: 2013-02-25
• Results First Submitted QC: 2013-02-25
• Last Update Submitted: 2013-02-25
• Results First Posted: 2013-04-04
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug Therapy	FDA approved rate and rhythm control drugs	FDA approved rate and rhythm control drugs
Atrioventricular Node (AVN) Ablation / Pacing	AV Node ablation and device implant	AV Node ablation and device implant

Primary Outcome Measures

Name	Time	Method
Cardiac Hospitalization Within Six Months of Enrollment	Six months after enrollment	Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.

Trial Locations

Locations (6)

University of Calgary and Calgary Health Region; 🇨🇦 Calgary, Alberta, Canada

Chattanooga Heart Institute; 🇺🇸 Chattanooga, Tennessee, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

The Heart Group; 🇺🇸 Evansville, Indiana, United States