Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation

Catheter Ablation for Atrial Fibrillation: A Multicenter Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: catheter ablation

• Study Type: Interventional
• Enrollment (Anticipated): 2040
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Renmin Hospital of Wuhan University
      • Contact: Cong-xin Huang, doctor; Phone Number: 13907131546; Email: huangcongxin@yahoo.com.cn
      • Principal Investigator: Cong-xin Huang, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ablation

Procedure: catheter ablation; circumferential pulmonary vein isolation complex fractionated atrial electrograms ablation circumferential pulmonary vein isolation combined left atrial roof ablation circumferential pulmonary vein isolation combined left atrial isthmus ablation circumferential pulmonary vein isolation combined left atrial roof and isthmus ablation circumferential pulmonary vein isolation combined complex fractionated atrial electrograms ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
recurrence of atrial arrhythmias (AF, AFL, AT)	3 month
recurrence of atrial arrhythmias (AF, AFL, AT)	12 month
recurrence of atrial arrhythmias (AF, AFL, AT)	1 month
recurrence of atrial arrhythmias (AF, AFL, AT)	6 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with all-cause death	3 month
Number of participants with all-cause death	12 month
severe blooding complications	3 month
severe blooding complications	12 month
cardio-cerebrovascular complications	3 month
cardio-cerebrovascular complications	12 month
Number of participants with cardiovascular death events	3 month
Number of participants with cardiovascular death events	12 month
Number of participants with all-cause death	1 month
Number of participants with all-cause death	6 month
severe blooding complications	1 month
severe blooding complications	6 month
cardio-cerebrovascular complications	1 month
cardio-cerebrovascular complications	6 month
Number of participants with cardiovascular death events	1 month
Number of participants with cardiovascular death events	6 month

Collaborators and Investigators

• Sponsor: Wuhan University
• Collaborators: West China Hospital; Guangdong Provincial People's Hospital; Shanghai Chest Hospital; Capital Medical University; Nanjing Medical University; Peking Union Medical College; Dalian Medical University
• Investigators: Study Chair: Cong-xin Huang, doctor, Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: April 27, 2010
• First Posted (Estimate): April 29, 2010

Study Record Updates

• Last Update Posted (Estimate): April 29, 2010
• Last Update Submitted That Met QC Criteria: April 27, 2010
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AFCT001