Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation (CABAL)
Primary Purpose
Atrial Fibrillation
Status
Withdrawn
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Antiarrhythmic drug
Catheter ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Catheter ablation
Eligibility 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
Sites / Locations
- Valley Health System
- State Research Institute of Circulation Pathology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Antiarrhythmic drug
Catheter ablation
Arm Description
Class I or III antiarrhythmic drug
Pulmonary vein isolation
Outcomes
Primary Outcome Measures
Percentage of AF burden
The percentage of AF burden defined through continuous monitoring using an implnatage loop recorder (ILR)
Secondary Outcome Measures
All-death death
All-cause death, thromboembolic events, hospitalizations, procedural complications, drug adverse effects, and number of crossovers
Full Information
NCT ID
NCT01505296
First Posted
December 28, 2011
Last Updated
December 13, 2014
Sponsor
Valley Health System
Collaborators
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01505296
Brief Title
Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation
Acronym
CABAL
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 Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Never initiated
Study Start Date
December 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Valley Health System
Collaborators
Biosense Webster, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Catheter ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antiarrhythmic drug
Arm Type
Active Comparator
Arm Description
Class I or III antiarrhythmic drug
Arm Title
Catheter ablation
Arm Type
Experimental
Arm Description
Pulmonary vein isolation
Intervention Type
Drug
Intervention Name(s)
Antiarrhythmic drug
Other Intervention Name(s)
Rhythmol, Tambocor, Betapace, Tikosyn
Intervention Description
propafenone, flecainide, sotalol, dofetilide
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation
Other Intervention Name(s)
Thermocool
Intervention Description
Complete PVI
Primary Outcome Measure Information:
Title
Percentage of AF burden
Description
The percentage of AF burden defined through continuous monitoring using an implnatage loop recorder (ILR)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
All-death death
Description
All-cause death, thromboembolic events, hospitalizations, procedural complications, drug adverse effects, and number of crossovers
Time Frame
4 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Steinberg, MD
Organizational Affiliation
Valley Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evegny Pokushalou, MD
Organizational Affiliation
State Resarch Institute of Circulation Pathology, Novosibirsk, Siberia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valley Health System
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation
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