Catheter Ablation Versus Antiarrythmic Drugs for Atrial Fibrillation in China

Atrial Fibrillation Clinical Trial

Official title:

Atrial Fibrillation Therapy: A Multi-Center Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01341353
• Other study ID #: CAPA001
• Status: Recruiting
• Phase: Phase 4
• First received: April 21, 2011
• Last updated: April 21, 2011
• Start date: April 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2011
• Source: Wuhan University
• Contact: Cong xin Huang, doctor
• Phone: 13907131546
• Email: huangcongxin[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Drug:
• Digaoxin,amiodarone,ß receptor antagonist, Calcium Antagonists

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (8)

Lead Sponsor	Collaborator
Wuhan University	Capital Medical University, Dalian Medical University, Guangdong General Hospital, Nanjing Medical University, Peking Union Medical College, Shanghai Chest Hospital, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with all-cause death		3 month	Yes
Primary	Number of participants with all-cause death		12 month	Yes
Primary	Number of participants with all-cause death		24 month	Yes
Primary	Number of participants with all-cause death		36 month	Yes
Primary	severe blooding complications		3 month	Yes
Primary	severe blooding complications		12 month	Yes
Primary	severe blooding complications		24 month	Yes
Primary	severe blooding complications		36 month	Yes
Primary	cardio-cerebrovascular complications		3 month	Yes
Primary	cardio-cerebrovascular complications		12 month	Yes
Primary	cardio-cerebrovascular complications		24 month	Yes
Primary	cardio-cerebrovascular complications		36 month	Yes
Primary	Number of participants with cardiovascular death events		3 month	Yes
Primary	Number of participants with cardiovascular death events		12 month	Yes
Primary	Number of participants with cardiovascular death events		24 month	Yes
Primary	Number of participants with cardiovascular death events		36 month	Yes
Secondary	recurrence of atrial arrhythmias (AF, AFL, AT)		3 month	No
Secondary	recurrence of atrial arrhythmias (AF, AFL, AT)		12 month	No
Secondary	recurrence of atrial arrhythmias (AF, AFL, AT)		24 month	No
Secondary	recurrence of atrial arrhythmias (AF, AFL, AT)		36 month	No
Secondary	resource utilization and costs		12 month	No
Secondary	resource utilization and costs		24 month	No
Secondary	resource utilization and costs		36 month	No