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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014