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

NCT ID: NCT00547794

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-11-30

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

Conditions

Atrial Fibrillation; Congestive Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CRT-D + AVJ Ablation

No interventions assigned to this group

Single-Chamber ICD + Pharmacological Therapy

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed Hamdan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah Health Sciences

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

Hamdan MH, Freedman RA, Gilbert EM, Dimarco JP, Ellenbogen KA, Page RL. Atrioventricular junction ablation followed by resynchronization therapy in patients with congestive heart failure and atrial fibrillation (AVERT-AF) study design. Pacing Clin Electrophysiol. 2006 Oct;29(10):1081-8. doi: 10.1111/j.1540-8159.2006.00502.x.

Reference Type: BACKGROUND

PMID: 17038140 (View on PubMed)

Other Identifiers

CRD 310

Identifier Type: -

Identifier Source: org_study_id