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Catheter Ablation Versus Antiarrythmic Drugs for Atrial Fibrillation in China

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by Wuhan University.
Recruitment status was:  Recruiting
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
  Purpose
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 Intervention Phase
Atrial Fibrillation
Procedure: catheter ablation
Drug: Digaoxin,amiodarone,β receptor antagonist, Calcium Antagonists
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atrial Fibrillation Therapy: A Multi-Center Clinical Study

Resource links provided by NLM:


Further study details as provided by Wuhan University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1800
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341353

Locations
China, Hubei
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
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
  More Information

Responsible Party: Cong-xin Huang,doctor
ClinicalTrials.gov Identifier: NCT01341353     History of Changes
Other Study ID Numbers: CAPA001 
Study First Received: April 21, 2011
Last Updated: April 21, 2011
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on December 06, 2016