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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by St. Jude Medical.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00547794
First received: October 19, 2007
Last updated: March 11, 2010
Last verified: March 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

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

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

Study Start Date: June 2007
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547794

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

Publications:

ClinicalTrials.gov Identifier: NCT00547794     History of Changes
Other Study ID Numbers: CRD 310
Study First Received: October 19, 2007
Last Updated: March 11, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013