Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation (CABAL)

December 13, 2014 updated by: Jonathan Steinberg,MD, Valley Health System

Randomized Comparison of Catheter Ablation Versus Anti-arrhythmic Drug Therapy in Patients With Recently Diagnosed Paroxysmal Atrial Fibrillation as Assessed by a Continuous Implantable Monitor

The objective is to compare the progression of Atrial Fib (AF) burden by continuous monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation (PVI) versus anti-arrhythmic drug (AAD) therapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Randomized, multicenter clinical trial comparing medical therapy (Group I) with ablation therapy(Group II). Randomization will be determined by opening a sealed envelope. All patients will be implanted with an implantable loop recorder and followed every three months.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation
        • State Research Institute of Circulation Pathology
  • United States
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • Valley Health System

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with recently diagnosed paroxysmal AF who are eligible to receive specific rhythm control therapy

Exclusion Criteria:

  • Previous treatment with Class IC or class III AAD
  • Previous AF ablation procedure
  • Congestive heart failure (NYHA III-IV functional class)
  • Left Ventricle ejection fraction less than 35%
  • Left atrial diameter > 55mm
  • Unwillingness to participate

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antiarrhythmic drug
Class I or III antiarrhythmic drug
Drug: Antiarrhythmic drug
propafenone, flecainide, sotalol, dofetilide
Other Names:
  • Rhythmol, Tambocor, Betapace, Tikosyn
Experimental: Catheter ablation
Pulmonary vein isolation
Procedure: Catheter ablation
Complete PVI
Other Names:
  • Thermocool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of AF burden
Time Frame: 4 months
The percentage of AF burden defined through continuous monitoring using an implnatage loop recorder (ILR)
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-death death
Time Frame: 4 months
All-cause death, thromboembolic events, hospitalizations, procedural complications, drug adverse effects, and number of crossovers
4 months

Collaborators and Investigators

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

Sponsor

Valley Health System

Collaborators

Biosense Webster, Inc.

Investigators

  • Principal Investigator: Jonathan Steinberg, MD, Valley Health System
  • Principal Investigator: Evegny Pokushalou, MD, State Resarch Institute of Circulation Pathology, Novosibirsk, Siberia

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

December 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

December 28, 2011

First Submitted That Met QC Criteria

January 3, 2012

First Posted (Estimate)

January 6, 2012

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 13, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BWI-IIS-0143

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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