Clinical trial NCT00547794: AVJ Ablation Followed by Resynchronization Therapy in Patients With CHF and AF
Official title: AVERT-AF: Atrio-VEntricular Junction Ablation Followed by Resynchronization Therapy in Patients With Congestive Heart Failure and Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Fibrillation
Congestive Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-10-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with history of permanent AF and CHF

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

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

Primary outcomes:
measure: Exercise duration
timeFrame: 12 month post implant
Secondary outcomes:
measure: Quality of Life (QOL) via Minnesota Living With Heart Failure (MLWH) questionnaire
timeFrame: 12 month post implant
measure: NYHA Class Progression
timeFrame: 12 month post implant
measure: LVEF
timeFrame: 12 month post implant
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah Health Sciences
name: Mohamed Hamdan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.