Back to resultsComparison of Pulmonary Vein Isolation Versus AV Nodal Ablation With Biventricular Pacing for Patients With Atrial Fibrillation With Congestive Heart Failure (PABA CHF) (PABA CHF)
Primary Purpose
Atrial Fibrillation, Congestive Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary vein isolation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
composite of EF, 6-minute walk distance and MLWHF score
Secondary Outcome Measures
freedom from AF and left atrial size
Full Information
NCT ID
NCT00599976
First Posted
January 2, 2008
Last Updated
January 23, 2008
Sponsor
Azienda Policlinico Umberto I
Collaborators
The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00599976
Brief Title
Comparison of Pulmonary Vein Isolation Versus AV Nodal Ablation With Biventricular Pacing for Patients With Atrial Fibrillation With Congestive Heart Failure (PABA CHF)
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Azienda Policlinico Umberto I
Collaborators
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Congestive Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation
Other Intervention Name(s)
atrial fibrillation ablation
Intervention Description
Pulmonary vein isolation
Primary Outcome Measure Information:
Title
composite of EF, 6-minute walk distance and MLWHF score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
freedom from AF and left atrial size
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
18946063
Citation
Khan MN, Jais P, Cummings J, Di Biase L, Sanders P, Martin DO, Kautzner J, Hao S, Themistoclakis S, Fanelli R, Potenza D, Massaro R, Wazni O, Schweikert R, Saliba W, Wang P, Al-Ahmad A, Beheiry S, Santarelli P, Starling RC, Dello Russo A, Pelargonio G, Brachmann J, Schibgilla V, Bonso A, Casella M, Raviele A, Haissaguerre M, Natale A; PABA-CHF Investigators. Pulmonary-vein isolation for atrial fibrillation in patients with heart failure. N Engl J Med. 2008 Oct 23;359(17):1778-85. doi: 10.1056/NEJMoa0708234.
Results Reference
derived
Learn more about this trial
Comparison of Pulmonary Vein Isolation Versus AV Nodal Ablation With Biventricular Pacing for Patients With Atrial Fibrillation With Congestive Heart Failure (PABA CHF)
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