Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy
Recruiting · NCT05610215 · Interventional (participants receive a specific treatment) · Lead sponsor: China National Center for Cardiovascular Diseases
View the official record on ClinicalTrials.gov →Interventions studied
catheter ablationhybrid ablation
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients' age is ≥18 y
- 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)
- Non-obstructed left ventricular outflow obstruction with peak gradients \<30mmHg
- Concomitant 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 anticoagulation
- Left ventricular ejection fraction ≤40%
- Concomitant with left atrium or left atrial appendage emboli
- Concomitant with a coronary or valvular disease that indicates intervention
- Ischaemic stroke within 2 months
- Previous ablation history
- Uncontrolled hyper/hypothyroidism
- End-staged kidney failure
- Concomitantly involved in other trials
- Pregnant or breastfeeding, or women of childbearing age not using a reliable contraceptive method
- Concomitant with bacteremia or at an active phase of infection
- Anatomically 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
Where it is running
1 location listed.
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College - Beijing, China