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

NCT ID: NCT00599976

Last Updated: 2008-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2006-11-30

Brief Summary

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.

Conditions

Atrial Fibrillation; Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Pulmonary vein isolation

Pulmonary vein isolation

Intervention Type: PROCEDURE

Other Intervention Names

atrial fibrillation ablation

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Azienda Policlinico Umberto I

OTHER

Sponsor Role: lead

Responsible Party

Stanford University

References

Khan MN, Jais 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, Haissaguerre 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. doi: 10.1056/NEJMoa0708234.

Reference Type: DERIVED

PMID: 18946063 (View on PubMed)

Other Identifiers

No 757, ME 836 Czech Republic.

Identifier Type: -

Identifier Source: secondary_id

NA 007

Identifier Type: -

Identifier Source: org_study_id