Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation (CABAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01505296
Recruitment Status : Withdrawn (Never initiated)
First Posted : January 6, 2012
Last Update Posted : December 16, 2014
Biosense Webster, Inc.
Information provided by (Responsible Party):
Jonathan Steinberg,MD, Valley Health System

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Antiarrhythmic drug Procedure: Catheter ablation Phase 4

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2011
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Percentage of AF burden [ Time Frame: 4 months ]
    The percentage of AF burden defined through continuous monitoring using an implnatage loop recorder (ILR)

Secondary Outcome Measures :
  1. All-death death [ Time Frame: 4 months ]
    All-cause death, thromboembolic events, hospitalizations, procedural complications, drug adverse effects, and number of crossovers

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01505296

United States, New Jersey
Valley Health System
Ridgewood, New Jersey, United States, 07450
Russian Federation
State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation
Sponsors and Collaborators
Valley Health System
Biosense Webster, Inc.
Principal Investigator: Jonathan Steinberg, MD Valley Health System
Principal Investigator: Evegny Pokushalou, MD State Resarch Institute of Circulation Pathology, Novosibirsk, Siberia

Additional Information:
Responsible Party: Jonathan Steinberg,MD, Director Arrhythmia Services, Valley Health System, Valley Health System Identifier: NCT01505296     History of Changes
Other Study ID Numbers: BWI-IIS-0143
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014

Keywords provided by Jonathan Steinberg,MD, Valley Health System:
Catheter ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents