Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01505296
• Other study ID #: BWI-IIS-0143
• Status: Withdrawn
• Phase: Phase 4
• First received: December 28, 2011
• Last updated: December 13, 2014
• Start date: December 2011
• Est. completion date: January 2014

Study information

• Verified date: December 2014
• Source: Valley Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Antiarrhythmic drug
propafenone, flecainide, sotalol, dofetilide

Procedure:
• Catheter ablation
Complete PVI

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk
United States	Valley Health System	Ridgewood	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Valley Health System	Biosense Webster, Inc.

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of AF burden	The percentage of AF burden defined through continuous monitoring using an implnatage loop recorder (ILR)	4 months	Yes
Secondary	All-death death	All-cause death, thromboembolic events, hospitalizations, procedural complications, drug adverse effects, and number of crossovers	4 months	Yes