Clinical trial NCT01113294: Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation
Official title: Catheter Ablation for Atrial Fibrillation: A Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Wuhan University
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College
name: Shanghai Chest Hospital
name: Nanjing Medical University
name: West China Hospital
name: Guangdong Provincial People's Hospital
name: Dalian Medical University
name: Capital Medical University
First posted: 2010-04-29
Enrollment: 2040
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: recurrence of atrial arrhythmias (AF, AFL, AT)
timeFrame: 1 month
measure: recurrence of atrial arrhythmias (AF, AFL, AT)
timeFrame: 3 month
measure: recurrence of atrial arrhythmias (AF, AFL, AT)
timeFrame: 6 month
measure: recurrence of atrial arrhythmias (AF, AFL, AT)
timeFrame: 12 month
Secondary outcomes:
measure: Number of participants with all-cause death
timeFrame: 1 month
measure: Number of participants with all-cause death
timeFrame: 3 month
measure: Number of participants with all-cause death
timeFrame: 6 month
measure: Number of participants with all-cause death
timeFrame: 12 month
measure: severe blooding complications
timeFrame: 1 month
measure: severe blooding complications
timeFrame: 3 month
measure: severe blooding complications
timeFrame: 6 month
measure: severe blooding complications
timeFrame: 12 month
measure: cardio-cerebrovascular complications
timeFrame: 1 month
measure: cardio-cerebrovascular complications
timeFrame: 3 month
measure: cardio-cerebrovascular complications
timeFrame: 6 month
measure: cardio-cerebrovascular complications
timeFrame: 12 month
measure: Number of participants with cardiovascular death events
timeFrame: 1 month
measure: Number of participants with cardiovascular death events
timeFrame: 3 month
measure: Number of participants with cardiovascular death events
timeFrame: 6 month
measure: Number of participants with cardiovascular death events
timeFrame: 12 month
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Cong-xin Huang, doctor
role: STUDY_CHAIR
References: