Study Stopped
Never initiated
Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation
CABAL
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
1 other identifier
interventional
N/A
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 28, 2011
CompletedFirst Posted
Study publicly available on registry
January 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedDecember 16, 2014
December 1, 2014
2.1 years
December 28, 2011
December 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of AF burden
The percentage of AF burden defined through continuous monitoring using an implnatage loop recorder (ILR)
4 months
Secondary Outcomes (1)
All-death death
4 months
Study Arms (2)
Antiarrhythmic drug
ACTIVE COMPARATORClass I or III antiarrhythmic drug
Catheter ablation
EXPERIMENTALPulmonary vein isolation
Interventions
propafenone, flecainide, sotalol, dofetilide
Eligibility Criteria
You may qualify if:
- Patients with recently diagnosed paroxysmal AF who are eligible to receive specific rhythm control therapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Valley Health Systemlead
- Biosense Webster, Inc.collaborator
Study Sites (2)
Valley Health System
Ridgewood, New Jersey, 07450, United States
State Research Institute of Circulation Pathology
Novosibirsk, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Steinberg, MD
Valley Health System
- PRINCIPAL INVESTIGATOR
Evegny Pokushalou, MD
State Resarch Institute of Circulation Pathology, Novosibirsk, Siberia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Arrhythmia Services, Valley Health System
Study Record Dates
First Submitted
December 28, 2011
First Posted
January 6, 2012
Study Start
December 1, 2011
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
December 16, 2014
Record last verified: 2014-12