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Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation

Catheter Ablation for Atrial Fibrillation: A Multicenter Clinical Trial

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01113294
Enrollment
2040
Registered
2010-04-29
Start date
2009-01-31
Completion date
2013-12-31
Last updated
2010-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

PROCEDUREcatheter 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

Sponsors

Peking Union Medical College
CollaboratorOTHER
Shanghai Chest Hospital
CollaboratorOTHER
Nanjing Medical University
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
Guangdong Provincial People's Hospital
CollaboratorOTHER
Dalian Medical University
CollaboratorOTHER
Capital Medical University
CollaboratorOTHER
Wuhan University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
recurrence of atrial arrhythmias (AF, AFL, AT)1 month

Secondary

MeasureTime frame
Number of participants with all-cause death1 month
severe blooding complications1 month
cardio-cerebrovascular complications1 month
Number of participants with cardiovascular death events1 month

Countries

China

Contacts

Primary ContactCong-xin Huang, doctor
huangcongxin@yahoo.com.cn13907131546

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026