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

Azienda Policlinico Umberto I

Status

Completed

Conditions

Atrial Fibrillation

Congestive Heart Failure

Treatments

Procedure: Pulmonary vein isolation

Study type

Interventional

Funder types

Other

Identifiers

NCT00599976

No 757, ME 836 Czech Republic.

NA 007

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.