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

January 23, 2008 updated by: Azienda Policlinico Umberto I

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
composite of EF, 6-minute walk distance and MLWHF score
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
freedom from AF and left atrial size
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Policlinico Umberto I

Collaborators

The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

January 2, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (Estimate)

January 24, 2008

Study Record Updates

Last Update Posted (Estimate)

January 24, 2008

Last Update Submitted That Met QC Criteria

January 23, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA 007
  • No 757, ME 836 Czech Republic.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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