AVJ Ablation Followed by Resynchronization Therapy in Patients With CHF and AF

Study Overview
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Brief Summary
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The purpose of the study is to determine if the combination of AVJ ablation followed by BiV pacing significantly improves functional status and exercise capacity compared to pharmacologic rate control in patients with chronic AF and depressed ejection fraction, regardless of rate or QRS duration.

Detailed Description
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This is a prospective, randomized, double blinded, multicenter study Patients meeting all the enrollment criteria are screened at enrollment and randomized to Group 1 (Pharmacological therapy + Single Chamber ICD) or Group 2 (AVJ Ablation + CRT-D) Screened patients are implanted with a FDA approved SJM ICD/CRT-D with compatible lead system Patients are followed at 1, 3, 6 and 12 months post implant Total # of centers - 20 centers Sample size - 180 patients

Official Title
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AVERT-AF: Atrio-VEntricular Junction Ablation Followed by Resynchronization Therapy in Patients With Congestive Heart Failure and Atrial Fibrillation

Conditions
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Atrial Fibrillation, Congestive Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic permanent AF Class I or II indication for ICD LVEF ≤ 35% within 6 months NYHA class II or III with a history of CHF Maximal tolerated drug therapy for CHF and rate control with a stable regimen for ≥ 30 days Ability to independently comprehend and complete a QoL questionnaire Ability to give informed consent for study participation and willingness and ability to comply with prescribed follow-up tests and scheduled evaluations Exclusion Criteria: Paroxysmal or persistent AF Class I indication for pacing (including AVJ ablation for poor rate control) Ability to walk ≥ 450 meters in 6 minutes Musculoskeletal disorders that prohibit the completion of a 450 meters walk NYHA class I or IV at the time of enrollment A contraindication to taking Coumadin therapy History of myocardial infarction, percutanous coronary intervention, or CABG in the past 30 days History of mitral valve surgery Prior attempts for cardiac resynchronization therapy The presence of an existing coronary sinus lead or epicardial lead Life expectancy < 1year Age < 18 yrs Current participation in other clinical studies except registry trials Use of calcium channel blockers Pregnancy Inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRT-D + AVJ Ablation<br> | |
| Single-Chamber ICD + Pharmacological Therapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise duration |  | 12 month post implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QOL) via Minnesota Living With Heart Failure (MLWH) questionnaire |  | 12 month post implant | 
| NYHA Class Progression |  | 12 month post implant | 
| LVEF |  | 12 month post implant |