This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation (CABAL)

This study has been withdrawn prior to enrollment.
(Never initiated)
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 13, 2014
Last verified: December 2014
  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
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:


Further study details as provided by Jonathan Steinberg,MD, Valley Health System:

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


Enrollment: 0
Study Start Date: December 2011
Study Completion Date: January 2014
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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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.
Investigators
Principal Investigator: Jonathan Steinberg, MD Valley Health System
Principal Investigator: Evegny Pokushalou, MD State Resarch Institute of Circulation Pathology, Novosibirsk, Siberia
  More Information

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 13, 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

ClinicalTrials.gov processed this record on June 28, 2017