Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation

Phase 4

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Catheter ablation; Drug: Antiarrhythmic drug

• Registration Number: NCT01505296
• Lead Sponsor: Valley Health System

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-28
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-06
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-13
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter ablation	Catheter ablation	Pulmonary vein isolation
Antiarrhythmic drug	Antiarrhythmic drug	Class I or III antiarrhythmic drug

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Valley Health System; 🇺🇸 Ridgewood, New Jersey, United States

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation