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

Launched by ABBOTT MEDICAL DEVICES · Oct 22, 2007

Keywords

ClinConnect Summary

* 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

Gender

ALL

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