Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation (CABAL)

Valley Health System

Status and phase: Withdrawn; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: Antiarrhythmic drug; Procedure: Catheter ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01505296

BWI-IIS-0143

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Antiarrhythmic drug

Active Comparator group

Description:

Class I or III antiarrhythmic drug

Treatment:

Drug: Antiarrhythmic drug

Catheter ablation

Experimental group

Description:

Pulmonary vein isolation

Treatment:

Procedure: Catheter ablation