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

NCT00547794 | Terminated DMC

• 1 other identifier: CRD 310
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• Exercise duration

  12 month post implant

Secondary Outcomes (3)

• Quality of Life (QOL) via Minnesota Living With Heart Failure (MLWH) questionnaire

  12 month post implant

• NYHA Class Progression

  12 month post implant

• LVEF

  12 month post implant

Study Arms (2)

CRT-D + AVJ Ablation

Single-Chamber ICD + Pharmacological Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with history of permanent AF and CHF

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• 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.

  PMID: 17038140 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed Hamdan, MD

  University of Utah Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 23, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

US (1)