Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation

NCT ID: NCT01113294

Last Updated: 2010-04-29

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

2040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-12-31

Brief Summary

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To compare the efficacy of different procedures, identify the optimal procedure, ablation sites, ablation endpoints and post-operative anticoagulation strategy, establish the optimal treatment strategy for atrial fibrillation.

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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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

Eligibility Criteria

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Inclusion Criteria

1. Atrial fibrillation 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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Peking Union Medical College

OTHER

Sponsor Role collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Dalian Medical University

OTHER

Sponsor Role collaborator

Capital Medical University

OTHER

Sponsor Role collaborator

Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Renmin hospital of Wuhan university

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

Phone: 13907131546

Email: [email protected]

Facility Contacts

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Cong-xin Huang, doctor

Role: primary

Other Identifiers

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AFCT001

Identifier Type: -

Identifier Source: org_study_id