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CompletedNCT00599976PABA CHFUpdated Jan 24, 2008

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

An interventional study of Pulmonary vein isolation in Atrial Fibrillation and Congestive Heart Failure, sponsored by Azienda Policlinico Umberto I. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-24.

Sponsored by Azienda Policlinico Umberto I · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Atrial Fibrillation
  • Congestive Heart Failure
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In context

Heart Failure

5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's enrollment of 81 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Azienda Policlinico Umberto I is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
81 participants (actual)

Interventions

  • ProcedurePulmonary vein isolation

    Pulmonary vein isolation

    Also known as: atrial fibrillation ablation

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What researchers measure

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. freedom from AF and left atrial size

    Time frame: 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 18946063 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00599976
Lead sponsor
Azienda Policlinico Umberto I
Collaborators
The Cleveland Clinic
First posted
Jan 24, 2008
Start date
Nov 2002
Primary completion
Nov 2006
Completion
Nov 2006
Last update
Jan 24, 2008

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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