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Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation (CABAL)

This study is currently recruiting participants.
Verified December 2012 by Valley Health System
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Jonathan Steinberg,MD, Valley Health System
ClinicalTrials.gov Identifier:
NCT01505296
First received: December 28, 2011
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Atrial Fibrillation
 Drug: Antiarrhythmic drug
Procedure: Catheter ablation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Valley Health System:

Primary Outcome Measures:
  • Percentage of AF burden [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    The percentage of AF burden defined through continuous monitoring using an implnatage loop recorder (ILR)


Secondary Outcome Measures:
  • All-death death [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    All-cause death, thromboembolic events, hospitalizations, procedural complications, drug adverse effects, and number of crossovers


Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505296

Contacts
Contact: Kathleen B Sayles, BSN 201 447 8453 ksayles@valleyhealth.com

Locations
United States, New Jersey
Valley Health System Recruiting
Ridgewood, New Jersey, United States, 07450
Principal Investigator: Jonathan Steinberg, MD            
Sub-Investigator: Dan Musat, MD            
Sub-Investigator: Suneet Mittal, MD            
Russian Federation
State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation
Principal Investigator: Evgeny Pokushalov, MD, PhD            
Sponsors and Collaborators
Valley Health System
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
  More Information

Additional Information:
Click here for more information  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jonathan Steinberg,MD, Director Arrhythmia Services, Valley Health System, Valley Health System
ClinicalTrials.gov Identifier: NCT01505296     History of Changes
Other Study ID Numbers: BWI-IIS-0143
Study First Received: December 28, 2011
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Valley Health System:
Catheter ablation

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

ClinicalTrials.gov processed this record on May 21, 2013