Catheter Ablation Versus Antiarrythmic Drugs for Atrial Fibrillation in China - Full Text View

Sponsor:	Wuhan University
Collaborators:	Captital 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

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

Drug Information available for: Calcium Gluconate Amiodarone Amiodarone hydrochloride

U.S. FDA Resources

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

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
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

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

Captital 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

No publications provided

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
Anti-Arrhythmia Agents
Calcium Channel Blockers

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Membrane Transport Modulators

ClinicalTrials.gov processed this record on May 23, 2012