Catheter Ablation Versus Antiarrythmic Drugs for Atrial Fibrillation in China

NCT ID: NCT01341353

Last Updated: 2011-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antiarrythmic Drugs

Group Type ACTIVE_COMPARATOR

Digaoxin,amiodarone,β receptor antagonist, Calcium Antagonists

Intervention Type DRUG

ablation

Group Type EXPERIMENTAL

catheter ablation

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Digaoxin,amiodarone,β receptor antagonist, Calcium Antagonists

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role collaborator

Peking Union Medical College

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Dalian Medical University

OTHER

Sponsor Role collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role collaborator

Wuhan University

OTHER

Sponsor Role lead

Principal Investigators

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Cong xin Huang, doctor

Role: STUDY_CHAIR

Renmin Hospital of Wuhan University

Locations

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Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Cong xin Huang, doctor

Role: CONTACT

13907131546

Facility Contacts

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Cong xin Huang, doctor

Role: primary

13907131546

Other Identifiers

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CAPA001

Identifier Type: -

Identifier Source: org_study_id

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