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

Terminated

• Conditions: Atrial Fibrillation; Congestive Heart Failure

• Registration Number: NCT00547794
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-10-19
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-23
• Primary Completion: 2010-08
• Study Completion: 2010-11
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exercise duration	12 month post implant

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States