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Not Yet Recruiting NCT05610215

Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy

Conditions: Atrial Fibrillation, Cardiomyopathy, Hypertrophic, Radiofrequency Ablation

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 66
Sponsor: China National Center for Cardiovascular Diseases

Location: China

Summary

The goal of this clinical trial is to compare the rhythm control effect in hypertrophic non-obstructive patients with non-paroxysmal atrial fibrillation by either concomitant catheter endocardial and thoracoscopic epicardial ablation or catheter ablation alone. The study aims to see if concomitant hybrid ablation can more effectively achieve rhythm control effect than catheter ablation alone in non-paroxysmal atrial fibrillation patients with hypertrophic cardiomyopathy.

Eligibility Criteria

Inclusion Criteria:Patients' age is ≥18 yClinically 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)Non-obstructed left ventricular outflow obstruction with peak gradients <30mmHgConcomitant with persistent atrial fibrillation (7 days<sustained episode lasting<3 years) with drug-refractory symptoms.Be able to understand the contents of the trial, and provide written informed consent to participate in this investigation.Exclusion Criteria:Patients with left atrial size >60 mm (2-dimensional echocardiography, parasternal long-axis view)Contraindicated to systemic anticoagulationLeft ventricular ejection fraction ≤40%Concomitant with left atrium or left atrial appendage emboliConcomitant with severe mitral or tricuspid regurgitationConcomitant with coronary artery disease or valvular disease that needs open heart surgeriesIschaemic stroke within 2 monthsPrevious ablation historyUncontrolled hyper/hypothyroidismEnd-staged kidney failureConcomitantly involved in other trialsPregnant or breastfeeding, or women of childbearing age not using a reliable contraceptive methodConcomitant with bacteremia or at an active phase of infectionAnatomically not suitable for thoracoscopic surgery(history of chest surgery or radiotherapy, etc.)Unwilling or unable to comply with all peri-ablation and follow-up requirements

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05610215). StuddyBuddy aggregates publicly available trial information.