AVJ Ablation Followed by Resynchronization Therapy in Patients With CHF and AF (AVERT-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00547794
Recruitment Status : Terminated (Difficulty in patient enrollment)
First Posted : October 23, 2007
Last Update Posted : May 8, 2015
Information provided by (Responsible Party):
St. Jude Medical

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.

Condition or disease
Atrial Fibrillation Congestive Heart Failure

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 Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AVERT-AF: Atrio-VEntricular Junction Ablation Followed by Resynchronization Therapy in Patients With Congestive Heart Failure and Atrial Fibrillation
Study Start Date : June 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

CRT-D + AVJ Ablation
Single-Chamber ICD + Pharmacological Therapy

Primary Outcome Measures :
  1. Exercise duration [ Time Frame: 12 month post implant ]

Secondary Outcome Measures :
  1. Quality of Life (QOL) via Minnesota Living With Heart Failure (MLWH) questionnaire [ Time Frame: 12 month post implant ]
  2. NYHA Class Progression [ Time Frame: 12 month post implant ]
  3. LVEF [ Time Frame: 12 month post implant ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with history of permanent AF and CHF

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00547794

United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Mohamed Hamdan, MD University of Utah Health Sciences

Responsible Party: St. Jude Medical Identifier: NCT00547794     History of Changes
Other Study ID Numbers: CRD 310
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes