Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
(Difficulty in patient enrollment)
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00547794
First received: October 19, 2007
Last updated: May 6, 2015
Last verified: May 2015
  Purpose
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
Atrial Fibrillation
Congestive Heart Failure

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Exercise duration [ Time Frame: 12 month post implant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life (QOL) via Minnesota Living With Heart Failure (MLWH) questionnaire [ Time Frame: 12 month post implant ] [ Designated as safety issue: No ]
  • NYHA Class Progression [ Time Frame: 12 month post implant ] [ Designated as safety issue: No ]
  • LVEF [ Time Frame: 12 month post implant ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: June 2007
Study Completion Date: November 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
CRT-D + AVJ Ablation
Single-Chamber ICD + Pharmacological Therapy

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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with history of permanent AF and CHF
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547794

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

Publications:
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00547794     History of Changes
Other Study ID Numbers: CRD 310 
Study First Received: October 19, 2007
Last Updated: May 6, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on December 02, 2016