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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Withdrawn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
Valley Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Catheter ablation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 28, 2011
Last Updated
December 13, 2014
Sponsor
Valley Health System
Collaborators
Biosense Webster, Inc.
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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Withdrawn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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