Comparison of Pulmonary Vein Isolation Versus AV Nodal Ablation With Biventricular Pacing for Patients With Atrial Fibrillation With Congestive Heart Failure (PABA CHF)

This study has been completed.

First Received on January 2, 2008. Last Updated on January 23, 2008 History of Changes

Sponsor:	Azienda Policlinico Umberto I
Collaborator:	The Cleveland Clinic
Information provided by:	Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier:	NCT00599976

Purpose

For patients with atrial fibrillation and heart failure, current treatment can include AV nodal ablation with biventricular pacing. Pulmonary vein isolation (PVI) is a new procedure for this patient population which attempts to restore sinus rhythm. This trial is a randomized controlled trial of AVN ablation with biventricular pacing versus PVI for atrial fibrillation patients with congestive heart failure.

Condition	Intervention
Atrial Fibrillation Congestive Heart Failure	Procedure: Pulmonary vein isolation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Controlled Trial of Pulmonary Vein Antrum Isolation vs. AV Node Ablation With Bi-Ventricular Pacing for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure (PABA CHF)

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Heart Failure

U.S. FDA Resources

Further study details as provided by Azienda Policlinico Umberto I:

Primary Outcome Measures:

composite of EF, 6-minute walk distance and MLWHF score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

freedom from AF and left atrial size [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	81
Study Start Date:	November 2002
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Pulmonary vein isolation

Other Name: atrial fibrillation ablation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with symptomatic atrial fibrillation with NYHA II-III symptoms despite the use of anti-arrhythmic medications.
Ejection fraction was required to be ≤ 40%.
Patients were required to be on a heart failure regimen that included beta-blockers and ace-inhibitors or angiotensin receptor blockers for all patients and spironolactone for NYHA III patients.
Patients were required to complete a 6-minute walk test and to be ≥ 18 years of age.

Exclusion Criteria:

Reversible causes of AF and heart failure (HF) such as pericarditis, hyperthyroidism, valvular heart disease and tachycardia-induced cardiomyopathy.
Post-operative AF, previous MAZE or MAZE-like surgery, previous left atrial instrumentation
Life expectancy ≤ 2 years
Likely cardiac transplant within the next 12 months
Contraindication to anti-arrhythmic medications and/or anticoagulation
Severe pulmonary disease
Documented intra-atrial thrombus
Tumor or other abnormalities which preclude catheter introduction
Cardiac surgery, MI or PCI within the past three months.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided by Azienda Policlinico Umberto I

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Khan MN, Jaïs P, Cummings J, Di Biase L, Sanders P, Martin DO, Kautzner J, Hao S, Themistoclakis S, Fanelli R, Potenza D, Massaro R, Wazni O, Schweikert R, Saliba W, Wang P, Al-Ahmad A, Beheiry S, Santarelli P, Starling RC, Dello Russo A, Pelargonio G, Brachmann J, Schibgilla V, Bonso A, Casella M, Raviele A, Haïssaguerre M, Natale A; PABA-CHF Investigators. Pulmonary-vein isolation for atrial fibrillation in patients with heart failure. N Engl J Med. 2008 Oct 23;359(17):1778-85.

Responsible Party:	Andrea Natale, Stanford University
ClinicalTrials.gov Identifier:	NCT00599976 History of Changes
Other Study ID Numbers:	NA 007, No 757, ME 836 Czech Republic.
Study First Received:	January 2, 2008
Last Updated:	January 23, 2008
Health Authority:	Italy: Ethics Committee

Additional relevant MeSH terms:

Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012