Clinical trial NCT01341353: Catheter Ablation Versus Antiarrythmic Drugs for Atrial Fibrillation in China
Official title: Atrial Fibrillation Therapy: A Multi-Center Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Wuhan University
Sponsor class: OTHER
Collaborators: name: Capital Medical University
name: Peking Union Medical College
name: Guangdong Provincial People's Hospital
name: Nanjing Medical University
name: West China Hospital
name: Dalian Medical University
name: Shanghai Chest Hospital
First posted: 2011-04-25
Enrollment: 1800
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: The mainstay of treatment for atrial fibrillation remains pharmacological;however,catheter ablation has increasingly been used over the last decades. The relative merits of each strategy have not been extensively studied. Our study was designed to determine if catheter ablation is a feasible option as first-line therapy for treating patients with symptomatic AF.


Eligibility criteria: Inclusion Criteria:

* 1 Patients with symptomatic AF 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: Number of participants with all-cause death
timeFrame: 3 month
measure: Number of participants with all-cause death
timeFrame: 12 month
measure: Number of participants with all-cause death
timeFrame: 24 month
measure: Number of participants with all-cause death
timeFrame: 36 month
measure: severe blooding complications
timeFrame: 3 month
measure: severe blooding complications
timeFrame: 12 month
measure: severe blooding complications
timeFrame: 24 month
measure: severe blooding complications
timeFrame: 36 month
measure: cardio-cerebrovascular complications
timeFrame: 3 month
measure: cardio-cerebrovascular complications
timeFrame: 12 month
measure: cardio-cerebrovascular complications
timeFrame: 24 month
measure: cardio-cerebrovascular complications
timeFrame: 36 month
measure: Number of participants with cardiovascular death events
timeFrame: 3 month
measure: Number of participants with cardiovascular death events
timeFrame: 12 month
measure: Number of participants with cardiovascular death events
timeFrame: 24 month
measure: Number of participants with cardiovascular death events
timeFrame: 36 month
Secondary outcomes:
measure: recurrence of atrial arrhythmias (AF, AFL, AT)
timeFrame: 3 month
measure: recurrence of atrial arrhythmias (AF, AFL, AT)
timeFrame: 12 month
measure: recurrence of atrial arrhythmias (AF, AFL, AT)
timeFrame: 24 month
measure: recurrence of atrial arrhythmias (AF, AFL, AT)
timeFrame: 36 month
measure: resource utilization and costs
timeFrame: 12 month
measure: resource utilization and costs
timeFrame: 24 month
measure: resource utilization and costs
timeFrame: 36 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: