Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy
NCT ID: NCT05610215
Last Updated: 2024-08-30
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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RECRUITING
NA
66 participants
INTERVENTIONAL
2023-02-11
2026-12-31
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
SINGLE
Study Groups
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hybrid ablation
Participants in this group will receive concomitant thoracoscopic epicardial ablation and catheter endocardial ablation
hybrid ablation
simultaneous thoracoscopic epicardial and catheter endocardial ablation
catheter ablation
Participants in this group will receive catheter endocardial ablation only
catheter ablation
catheter endocardial ablation
Interventions
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hybrid ablation
simultaneous thoracoscopic epicardial and catheter endocardial ablation
catheter ablation
catheter endocardial ablation
Eligibility Criteria
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Inclusion Criteria
2. Clinically diagnosed hypertrophic cardiomyopathy (any left ventricular wall segment thickness ≥15 mm in genetical negative (or unknown genetical status) patients or ≥13mm in genetical positive ones-as measured by any imaging technique (echocardiography, cardiac magnetic resonance imaging or computed tomography)-that is not explained solely by loading conditions)
3. Non-obstructed left ventricular outflow obstruction with peak gradients \<30mmHg
4. Concomitant with persistent atrial fibrillation (7 days\<sustained episode lasting\<3 years) with drug-refractory symptoms.
5. Be able to understand the contents of the trial, and provide written informed consent to participate in this investigation.
Exclusion Criteria
2. Contraindicated to systemic anticoagulation
3. Left ventricular ejection fraction ≤40%
4. Concomitant with left atrium or left atrial appendage emboli
5. Concomitant with a coronary or valvular disease that indicates intervention
6. Ischaemic stroke within 2 months
7. Previous ablation history
8. Uncontrolled hyper/hypothyroidism
9. End-staged kidney failure
10. Concomitantly involved in other trials
11. Pregnant or breastfeeding, or women of childbearing age not using a reliable contraceptive method
12. Concomitant with bacteremia or at an active phase of infection
13. Anatomically not suitable for thoracoscopic surgery(history of chest surgery or radiotherapy, etc.)
14. Unwilling or unable to comply with all peri-ablation and follow-up requirements
18 Years
ALL
No
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Zhe Zheng, MD.PhD
Role: STUDY_CHAIR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Tang Y, Li L, Chen S, Xue Y, Guo H, Song L, Tang M, Yao Y, Zheng Z. Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial. BMJ Open. 2024 Oct 9;14(10):e089284. doi: 10.1136/bmjopen-2024-089284.
Other Identifiers
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2022-1736
Identifier Type: -
Identifier Source: org_study_id
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