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

Atrial Fibrillation Clinical Trial

— PABA CHF  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599976
• Other study ID #: NA 007
• Secondary ID: No 757, ME 836 C
• Status: Completed
• Phase: N/A
• First received: January 2, 2008
• Last updated: January 23, 2008
• Start date: November 2002
• Est. completion date: November 2006

Study information

• Verified date: December 2007
• Source: Azienda Policlinico Umberto I
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Congestive Heart Failure
• Heart Failure

Intervention

Procedure:
• Pulmonary vein isolation
Pulmonary vein isolation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Policlinico Umberto I	The Cleveland Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of EF, 6-minute walk distance and MLWHF score		6 months	No
Secondary	freedom from AF and left atrial size		6 months	No