Clinical trial NCT05610215: Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy
Official title: Concomitant Hybrid Versus Catheter Ablation for Reinforcing Therapeutic Effect of Atrial Fibrillation With Hypertrophic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Cardiomyopathy, Hypertrophic
Radiofrequency Ablation
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2022-11-09
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: After informed consent, 66 eligible admissions will be recruited in 2 centers. Eligible participants will be randomly divided (1:1) into either hybrid or catheter ablation arms, looking for a primary outcome of 1-year freedom from atrial arrhythmias.

Eligibility criteria: Inclusion Criteria:

1. Patients' age is ≥18 y
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:

1. Patients with left atrial size \>60 mm (2-dimensional echocardiography, parasternal long-axis view)
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

Primary outcomes:
measure: Freedom from documented recurrence (off-AADs)
timeFrame: within 3-12 months
Secondary outcomes:
measure: All cause mortality
timeFrame: within 12 months
measure: Cardiovascular related mortality
timeFrame: within 12 months
measure: Cerebral infarction/ischemia
timeFrame: within 12 months
measure: Periferal arterial embolism
timeFrame: within 12 months
measure: All-cause rehospitalization
timeFrame: within 3-12 months
measure: Heart failure related rehospitalization
timeFrame: within 3-12 months
measure: Freedom from documented recurrence (on-AADs)
timeFrame: within 3-12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Zhe Zheng, MD.PhD
role: STUDY_CHAIR
References: