Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation
Catheter Ablation for Atrial Fibrillation: A Multicenter Clinical Trial
1 other identifier
interventional
2,040
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 atrial-fibrillation
Started Jan 2009
Longer than P75 for phase_4 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 21, 2010
CompletedFirst Posted
Study publicly available on registry
April 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedApril 29, 2010
January 1, 2009
3.9 years
April 21, 2010
April 27, 2010
Conditions
Outcome Measures
Primary Outcomes (4)
recurrence of atrial arrhythmias (AF, AFL, AT)
1 month
recurrence of atrial arrhythmias (AF, AFL, AT)
3 month
recurrence of atrial arrhythmias (AF, AFL, AT)
6 month
recurrence of atrial arrhythmias (AF, AFL, AT)
12 month
Secondary Outcomes (16)
Number of participants with all-cause death
1 month
Number of participants with all-cause death
3 month
Number of participants with all-cause death
6 month
Number of participants with all-cause death
12 month
severe blooding complications
1 month
- +11 more secondary outcomes
Study Arms (1)
ablation
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- Atrial fibrillation recorded by ECG or Holter;
- Age: 18 \~ 75 years;
- Patients who are willing to enroll in the trial
You may not qualify if:
- Patients accompanied hyperthyroidism;
- Patients with sever liver or renal dysfunction;
- Patients with sever cardiac dysfunction;
- Patients had previous radiofrequency catheter ablation in the LA or Maze surgical procedure;
- Patients with emboli in atrium;
- Pregnant woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wuhan Universitylead
- Peking Union Medical Collegecollaborator
- Shanghai Chest Hospitalcollaborator
- Nanjing Medical Universitycollaborator
- West China Hospitalcollaborator
- Guangdong Provincial People's Hospitalcollaborator
- Dalian Medical Universitycollaborator
- Capital Medical Universitycollaborator
Study Sites (1)
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cong-xin Huang, doctor
Renmin Hospital of Wuhan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 21, 2010
First Posted
April 29, 2010
Study Start
January 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2013
Last Updated
April 29, 2010
Record last verified: 2009-01