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

NCT00599976 | Completed

• 2 other identifiers: NA 007No 757, ME 836 Czech Republic.
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

• freedom from AF and left atrial size

  6 months

Interventions

Pulmonary vein isolation PROCEDURE

Pulmonary vein isolation

Also known as: atrial fibrillation ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Policlinico Umberto I: lead
• The Cleveland Clinic: collaborator

Related Publications (1)

• 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.

  PMID: 18946063 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 24, 2008
• Study Start: November 1, 2002
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: January 24, 2008

Record last verified: 2007-12