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Catheter Ablation Versus Antiarrythmic Drugs for Atrial Fibrillation in China

This study is currently recruiting participants.
Verified April 2011 by Wuhan University
Sponsor:
Collaborators:
Capital Medical University
Peking Union Medical College
Guangdong General Hospital
Nanjing Medical University
West China Hospital
Dalian Medical University
Shanghai Chest Hospital
Information provided by:
Wuhan University
ClinicalTrials.gov Identifier:
NCT01341353
First received: April 21, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted

April 21, 2011
April 21, 2011
April 2011
December 2014   (final data collection date for primary outcome measure)
  • Number of participants with all-cause death [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • Number of participants with all-cause death [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Number of participants with all-cause death [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
  • Number of participants with all-cause death [ Time Frame: 36 month ] [ Designated as safety issue: Yes ]
  • severe blooding complications [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • severe blooding complications [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • severe blooding complications [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
  • severe blooding complications [ Time Frame: 36 month ] [ Designated as safety issue: Yes ]
  • cardio-cerebrovascular complications [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • cardio-cerebrovascular complications [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • cardio-cerebrovascular complications [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
  • cardio-cerebrovascular complications [ Time Frame: 36 month ] [ Designated as safety issue: Yes ]
  • Number of participants with cardiovascular death events [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • Number of participants with cardiovascular death events [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Number of participants with cardiovascular death events [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
  • Number of participants with cardiovascular death events [ Time Frame: 36 month ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • recurrence of atrial arrhythmias (AF, AFL, AT) [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • recurrence of atrial arrhythmias (AF, AFL, AT) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • recurrence of atrial arrhythmias (AF, AFL, AT) [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • recurrence of atrial arrhythmias (AF, AFL, AT) [ Time Frame: 36 month ] [ Designated as safety issue: No ]
  • resource utilization and costs [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • resource utilization and costs [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • resource utilization and costs [ Time Frame: 36 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Catheter Ablation Versus Antiarrythmic Drugs for Atrial Fibrillation in China
Atrial Fibrillation Therapy: A Multi-Center Clinical Study

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
  • 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,β receptor antagonist, Calcium Antagonists
  • Active Comparator: Antiarrythmic Drugs
    Intervention: Drug: Digaoxin,amiodarone,β receptor antagonist, Calcium Antagonists
  • Experimental: ablation
    Intervention: Procedure: catheter ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1800
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Cong xin Huang, doctor 13907131546 huangcongxin@yahoo.com.cn
China
 
NCT01341353
CAPA001
Yes
Cong-xin Huang,doctor
Wuhan University
  • Capital Medical University
  • Peking Union Medical College
  • Guangdong General Hospital
  • Nanjing Medical University
  • West China Hospital
  • Dalian Medical University
  • Shanghai Chest Hospital
Study Chair: Cong xin Huang, doctor Renmin Hospital of Wuhan University
Wuhan University
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP