Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01505296

Acronym

CABAL

Enrollment

Registered

2012-01-06

Start date

2011-12-31

Completion date

2014-01-31

Last updated

2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Catheter ablation

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.

Interventions

DRUGAntiarrhythmic drug

propafenone, flecainide, sotalol, dofetilide

PROCEDURECatheter ablation

Complete PVI

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of AF burden	4 months	The percentage of AF burden defined through continuous monitoring using an implnatage loop recorder (ILR)

Secondary

Measure	Time frame	Description
All-death death	4 months	All-cause death, thromboembolic events, hospitalizations, procedural complications, drug adverse effects, and number of crossovers

Countries

Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026