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Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation

This study is currently recruiting participants.
Verified January 2009 by Wuhan University
Sponsor:
Collaborators:
Peking Union Medical College
Shanghai Chest Hospital
Nanjing Medical University
West China Hospital
Guangdong General Hospital
Dalian Medical University
Capital Medical University
Information provided by:
Wuhan University
ClinicalTrials.gov Identifier:
NCT01113294
First received: April 21, 2010
Last updated: April 27, 2010
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
 Procedure: catheter ablation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Catheter Ablation for Atrial Fibrillation: A Multicenter Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wuhan University:

Primary Outcome Measures:
  • recurrence of atrial arrhythmias (AF, AFL, AT) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • recurrence of atrial arrhythmias (AF, AFL, AT) [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • recurrence of atrial arrhythmias (AF, AFL, AT) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • recurrence of atrial arrhythmias (AF, AFL, AT) [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with all-cause death [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Number of participants with all-cause death [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • Number of participants with all-cause death [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • Number of participants with all-cause death [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • severe blooding complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • severe blooding complications [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • severe blooding complications [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • severe blooding complications [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • cardio-cerebrovascular complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • cardio-cerebrovascular complications [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • cardio-cerebrovascular complications [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • cardio-cerebrovascular complications [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Number of participants with cardiovascular death events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Number of participants with cardiovascular death events [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • Number of participants with cardiovascular death events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • Number of participants with cardiovascular death events [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2040
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113294

Contacts
Contact: Cong-xin Huang, doctor 13907131546 huangcongxin@yahoo.com.cn

Locations
China, Hubei
Renmin Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430060
Contact: Cong-xin Huang, doctor     13907131546     huangcongxin@yahoo.com.cn    
Principal Investigator: Cong-xin Huang, doctor            
Sponsors and Collaborators
Wuhan University
Peking Union Medical College
Shanghai Chest Hospital
Nanjing Medical University
West China Hospital
Guangdong General Hospital
Dalian Medical University
Capital Medical University
Investigators
Study Chair: Cong-xin Huang, doctor Renmin Hospital of Wuhan University
  More Information

No publications provided

Responsible Party: Cong-xin Huang, Renmin hospital of Wuhan university
ClinicalTrials.gov Identifier: NCT01113294     History of Changes
Other Study ID Numbers: AFCT001
Study First Received: April 21, 2010
Last Updated: April 27, 2010
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013