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

This study has been completed.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by:
Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier:
NCT00599976
First received: January 2, 2008
Last updated: January 23, 2008
Last verified: December 2007
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Congestive Heart Failure
Procedure: Pulmonary vein isolation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Azienda Policlinico Umberto I:

Primary Outcome Measures:
  • composite of EF, 6-minute walk distance and MLWHF score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • freedom from AF and left atrial size [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: November 2002
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Pulmonary vein isolation
    Pulmonary vein isolation
    Other Name: atrial fibrillation ablation
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Azienda Policlinico Umberto I

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrea Natale, Stanford University
ClinicalTrials.gov Identifier: NCT00599976     History of Changes
Other Study ID Numbers: NA 007, No 757, ME 836 Czech Republic.
Study First Received: January 2, 2008
Last Updated: January 23, 2008
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014