Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Catheter Ablation for Atrial Fibrillation: A Multicenter Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01113294
• Other study ID #: AFCT001
• Status: Recruiting
• Phase: Phase 4
• First received: April 21, 2010
• Last updated: April 27, 2010
• Start date: January 2009
• Est. completion date: December 2013

Study information

• Verified date: January 2009
• 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2040
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

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	recurrence of atrial arrhythmias (AF, AFL, AT)		1 month	No
Primary	recurrence of atrial arrhythmias (AF, AFL, AT)		3 month	No
Primary	recurrence of atrial arrhythmias (AF, AFL, AT)		6 month	No
Primary	recurrence of atrial arrhythmias (AF, AFL, AT)		12 month	No
Secondary	Number of participants with all-cause death		1 month	Yes
Secondary	Number of participants with all-cause death		3 month	Yes
Secondary	Number of participants with all-cause death		6 month	Yes
Secondary	Number of participants with all-cause death		12 month	Yes
Secondary	severe blooding complications		1 month	Yes
Secondary	severe blooding complications		3 month	Yes
Secondary	severe blooding complications		6 month	Yes
Secondary	severe blooding complications		12 month	Yes
Secondary	cardio-cerebrovascular complications		1 month	Yes
Secondary	cardio-cerebrovascular complications		3 month	Yes
Secondary	cardio-cerebrovascular complications		6 month	Yes
Secondary	cardio-cerebrovascular complications		12 month	Yes
Secondary	Number of participants with cardiovascular death events		1 month	Yes
Secondary	Number of participants with cardiovascular death events		3 month	Yes
Secondary	Number of participants with cardiovascular death events		6 month	Yes
Secondary	Number of participants with cardiovascular death events		12 month	Yes