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

Stopped early

Conditions studied: Atrial Fibrillation, Congestive Heart Failure

In brief

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.

Key facts

Study ID

NCT00547794

Run by

Abbott Medical Devices

People needed

14

Starts

2007-06-01

Expected to finish

2010-11-01

Last updated by the study team

2019-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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