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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Congestive Heart Failure Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pulmonary vein isolation

Procedure

Pulmonary vein isolation

Other names: atrial fibrillation ablation

Primary outcomes

composite of EF, 6-minute walk distance and MLWHF score

Time frame: 6 months

Secondary outcomes

freedom from AF and left atrial size

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Azienda Policlinico Umberto I

Other

Collaborators

The Cleveland Clinic

Registry information

Official study 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)

Acronym: PABA CHF

Important dates

Study start: 2002
Primary completion: 2006
Study completion: 2006
First posted: Jan 24, 2008
Registry last updated: Jan 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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