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

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00599976

Acronym

PABA CHF

Enrollment

Registered

2008-01-24

Start date

2002-11-30

Completion date

2006-11-30

Last updated

2008-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Congestive Heart Failure

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.

Interventions

PROCEDUREPulmonary vein isolation

Pulmonary vein isolation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
composite of EF, 6-minute walk distance and MLWHF score	6 months

Secondary

Measure	Time frame
freedom from AF and left atrial size	6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026