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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
ChiCTR-TRC-09000591 |
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Date of registration:
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2010-06-26 |
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Primary sponsor: |
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Public title:
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Comparison of two different ablation strategies in patients with persistent atrial fibrillaiton: a randomized controlled trial
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Scientific title:
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Comparison of two different ablation strategies in patients with persistent atrial fibrillaiton: a randomized controlled trial |
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Date of first enrolment:
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2009-11-13 |
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Target sample size:
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Group A:73;Group B:73;Total:146; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org/en/proj/show.aspx?proj=809 |
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Study type:
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Interventional |
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Study design:
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Randomized parallel control
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Countries of recruitment
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China
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Contacts
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Name:
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Caihua Sang
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Address:
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Department of Cardiology-Center for Atrial Fibrillation, Beijing Anzhen Hospital, Capital Medical University, 2 Anzhen Road, Chaoyang District, Beijing 100029, P. R. China
100029
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Telephone:
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+86 10 64456587 |
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Email:
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sch9613070@yahoo.com.cn |
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Affiliation:
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Name:
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Changsheng Ma
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Address:
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Department of Cardiology-Center for Atrial Fibrillation, Beijing Anzhen Hospital, Capital Medical University, 2 Anzhen Road, Chaoyang District, Beijing 100029, P. R. China.
100029
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Telephone:
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+86 10 64456587 |
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Email:
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chshma@vip.sina.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 18 to 80 years old;
2. Experienced twice persistent symptomatic AF episodes documented by ECG with an interval of at least 7 days in latest 6 months;
3. With symptomatic AF respondent to amiodarone;
4. Had willingness, ability and commitment to participate in follow-up.
Exclusion criteria: 1. Experienced coronary artery bypass graft surgery within 1 year of screening;
2. With uncontrolled congestive heart failure;
3. Having significant valvular disease and/or prosthetic heart valve(s);
4. With myocardial infarction or stroke within 3 months of screening;
5. With Significant congenital heart disease;
6. Ejection fraction was <35% measured by echocardiography;
7. Allergic to contrast media;
8. Severe electrolyte abnormalities within 1 month of treatment;
9. Contraindication to warfarin or heparin;
10. Pulmonary emboli or stroke within 1 year before screening;
11. Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography;
12.Pregnant women;
13.having any contraindication to right or left sided heart catheterization;
14.Poor general health ;
15.Life expectancy less than 1 year.
Age minimum:
18
Age maximum:
80
Gender:
Both
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Health Condition(s) or Problem(s) studied
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atrial fibrillation
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Intervention(s)
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Group A:circumferential pulmonary vein ablation+atrial linear ablation(left atrial roof, mitral isthmus and cavo-tricuspid isthmus);Group B:circumferential pulmonary vein ablation+atrial linear ablation(left atrial roof, mitral isthmus and cavo-tricuspid isthmus)+complex fractionated atrial electrogram (CFAE) ablation;Total:;
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Primary Outcome(s)
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Conversion proportion to sinus rhythm after initial ablation procedure (including either by cardiove;
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Secondary Outcome(s)
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Atrial fibrillation- and atrial flutter- free proportion without antiarrhythmic-drug adnimistration ;
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Source(s) of Monetary Support
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Self funding
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