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

Atrial Fibrillation Clinical Trial

— AVERT-AF  

Official title:

AVERT-AF: Atrio-VEntricular Junction Ablation Followed by Resynchronization Therapy in Patients With Congestive Heart Failure and Atrial Fibrillation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00547794
• Other study ID #: CRD 310
• Status: Terminated
• Start date: June 2007
• Est. completion date: November 2010

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: November 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Congestive Heart Failure
• Heart Failure

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise duration		12 month post implant
Secondary	Quality of Life (QOL) via Minnesota Living With Heart Failure (MLWH) questionnaire		12 month post implant
Secondary	NYHA Class Progression		12 month post implant
Secondary	LVEF		12 month post implant