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Catheter Ablation Versus Antiarrythmic Drugs for Atrial Fibrillation in China

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ClinicalTrials.gov Identifier: NCT01341353
Recruitment Status : Unknown
Verified April 2011 by Wuhan University.
Recruitment status was:  Recruiting
First Posted : April 25, 2011
Last Update Posted : April 25, 2011
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

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: catheter ablation Drug: Digaoxin,amiodarone,β receptor antagonist, Calcium Antagonists Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Atrial Fibrillation Therapy: A Multi-Center Clinical Study
Study Start Date : April 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Antiarrythmic Drugs Drug: Digaoxin,amiodarone,β receptor antagonist, Calcium Antagonists
Experimental: ablation 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



Primary Outcome Measures :
  1. Number of participants with all-cause death [ Time Frame: 3 month ]
  2. Number of participants with all-cause death [ Time Frame: 12 month ]
  3. Number of participants with all-cause death [ Time Frame: 24 month ]
  4. Number of participants with all-cause death [ Time Frame: 36 month ]
  5. severe blooding complications [ Time Frame: 3 month ]
  6. severe blooding complications [ Time Frame: 12 month ]
  7. severe blooding complications [ Time Frame: 24 month ]
  8. severe blooding complications [ Time Frame: 36 month ]
  9. cardio-cerebrovascular complications [ Time Frame: 3 month ]
  10. cardio-cerebrovascular complications [ Time Frame: 12 month ]
  11. cardio-cerebrovascular complications [ Time Frame: 24 month ]
  12. cardio-cerebrovascular complications [ Time Frame: 36 month ]
  13. Number of participants with cardiovascular death events [ Time Frame: 3 month ]
  14. Number of participants with cardiovascular death events [ Time Frame: 12 month ]
  15. Number of participants with cardiovascular death events [ Time Frame: 24 month ]
  16. Number of participants with cardiovascular death events [ Time Frame: 36 month ]

Secondary Outcome Measures :
  1. recurrence of atrial arrhythmias (AF, AFL, AT) [ Time Frame: 3 month ]
  2. recurrence of atrial arrhythmias (AF, AFL, AT) [ Time Frame: 12 month ]
  3. recurrence of atrial arrhythmias (AF, AFL, AT) [ Time Frame: 24 month ]
  4. recurrence of atrial arrhythmias (AF, AFL, AT) [ Time Frame: 36 month ]
  5. resource utilization and costs [ Time Frame: 12 month ]
  6. resource utilization and costs [ Time Frame: 24 month ]
  7. resource utilization and costs [ Time Frame: 36 month ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01341353


Contacts
Contact: Cong xin Huang, doctor 13907131546 huangcongxin@yahoo.com.cn

Locations
China, Hubei
Renmin Hospital of Wuhan University Recruiting
Wuhan, Hubei, China
Contact: Cong xin Huang, doctor    13907131546    huangcongxin@yahoo.com.cn   
Principal Investigator: cong xin Huang, doctor         
Sponsors and Collaborators
Wuhan University
Capital Medical University
Peking Union Medical College
Guangdong General Hospital
Nanjing Medical University
West China Hospital
Dalian Medical University
Shanghai Chest Hospital
Investigators
Study Chair: Cong xin Huang, doctor Renmin Hospital of Wuhan University

Responsible Party: Cong-xin Huang,doctor
ClinicalTrials.gov Identifier: NCT01341353     History of Changes
Other Study ID Numbers: CAPA001
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: April 25, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Calcium Channel Blockers
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors