Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis.
NCT ID: NCT05085912
Last Updated: 2021-10-20
Study Results
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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UNKNOWN
NA
300 participants
INTERVENTIONAL
2021-11-01
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation
Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and driver ablation.
Group B
Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation
Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with posterior wall box isolation.
Group C
Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion
Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with vein of Marshall ethanol infusion.
Interventions
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Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and driver ablation.
Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with posterior wall box isolation.
Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with vein of Marshall ethanol infusion.
Eligibility Criteria
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Inclusion Criteria
2. Persistent AF with severe atrial fibrosis;
3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.
Exclusion Criteria
2. Having significant valvular disease;
3. With myocardial infarction or stroke within 6 months of screening;
4. With Significant congenital heart disease;
5. Ejection fraction was \<40% measured by echocardiography;
6. Allergic to contrast media;
7. Contraindication to anticoagulation medications;
8. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
9. Left atrial (LA) thrombus;
10. Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;
12\. Presence of an implanted cardioverter-defibrillator; 13. Previous history of cardiac surgery; 14. Poor general health; 15. Life expectancy less than 6 months.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Responsible Party
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Xu Liu
Professor, deputy director of cardiology department of Shanghai Chest Hospita
Central Contacts
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Other Identifiers
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DAAF
Identifier Type: -
Identifier Source: org_study_id