Heart Failure Clinical Trial
AVJ Ablation Followed by Resynchronization Therapy in Patients With CHF and AF
Summary
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.
Full Description
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
Eligibility Criteria
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
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There is 1 Location for this study
Salt Lake City Utah, 84108, United States
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