Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation

Phase 4

• Conditions: Atrial Fibrillation
• Interventions: Procedure: catheter ablation

• Registration Number: NCT01113294
• Lead Sponsor: Wuhan University

Brief Summary

To compare the efficacy of different procedures, identify the optimal procedure, ablation sites, ablation endpoints and post-operative anticoagulation strategy, establish the optimal treatment strategy for atrial fibrillation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-27
• Last Update Submitted: 2010-04-27
• Study First Posted: 2010-04-29
• Last Update Posted: 2010-04-29
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2040

Inclusion Criteria

1. Atrial fibrillation recorded by ECG or Holter;
2. Age: 18 ~ 75 years;
3. Patients who are willing to enroll in the trial

Exclusion Criteria

1. Patients accompanied hyperthyroidism;
2. Patients with sever liver or renal dysfunction;
3. Patients with sever cardiac dysfunction;
4. Patients had previous radiofrequency catheter ablation in the LA or Maze surgical procedure;
5. Patients with emboli in atrium;
6. Pregnant woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ablation	catheter ablation	-

Primary Outcome Measures

Name	Time	Method
recurrence of atrial arrhythmias (AF, AFL, AT)	12 month

Secondary Outcome Measures

Name	Time	Method
Number of participants with all-cause death	12 month
severe blooding complications	12 month
cardio-cerebrovascular complications	12 month
Number of participants with cardiovascular death events	12 month

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China