Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial.
Yajie Tang, Le Li, Sipeng Chen...
https://pubmed.ncbi.nlm.nih.gov/39384237Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05610215
Concomitant Hybrid Versus Catheter Ablation for Reinforcing Therapeutic Effect of Atrial Fibrillation With Hypertrophic Cardiomyopathy
Led by China National Center for Cardiovascular Diseases · Updated on 2024-08-30
66
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the rhythm control effects in patients with hypertrophic non-obstructive cardiomyopathy who have non-paroxysmal atrial fibrillation. The study aims to compare if a combined hybrid ablation approach, involving both thoracoscopic epicardial and catheter endocardial ablation, can better manage rhythm control than catheter ablation alone in these patients. This clinical trial is sponsored by the China National Center for Cardiovascular Diseases and includes 66 eligible participants. Participants will be randomly assigned to one of two groups. One group will receive a combination of thoracoscopic epicardial ablation and catheter endocardial ablation simultaneously, known as hybrid ablation. The other group will receive catheter endocardial ablation only. The main treatment period will assess outcomes over a one-year timeframe following the procedures. Throughout the study, participants will be monitored for freedom from atrial arrhythmias for 3 to 12 months without antiarrhythmic drugs, which is the primary outcome. Secondary outcomes include mortality rates, incidence of stroke or embolism, rehospitalization related to heart conditions, and rhythm control with antiarrhythmic drugs within the same period. Participants will undergo follow-ups and evaluations to track these outcomes and ensure safety and adherence to study requirements.
CONDITIONS
Brief Title
Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Clinically diagnosed hypertrophic cardiomyopathy with left ventricular wall thickness 15 mm in genetic negative or unknown status patients, or 13 mm in genetic positive patients, measured by imaging
- Non-obstructive left ventricular outflow with peak gradient less than 30 mmHg
- Persistent atrial fibrillation lasting more than 7 days but less than 3 years with drug-refractory symptoms
- Ability to understand the trial and provide written informed consent
You will not qualify if you...
- Left atrial size greater than 60 mm by echocardiography
- Contraindication to systemic anticoagulation
- Left ventricular ejection fraction 40% or less
- Presence of emboli in left atrium or left atrial appendage
- Coronary or valvular disease requiring intervention
- Ischemic stroke within 2 months
- Previous ablation history
- Uncontrolled hyperthyroidism or hypothyroidism
- End-stage kidney failure
- Participation in other clinical trials
- Pregnant or breastfeeding, or women of childbearing age not using reliable contraception
- Active infection or bacteremia
- Anatomical unsuitability for thoracoscopic surgery (e.g., prior chest surgery or radiotherapy)
- Unwilling or unable to comply with peri-ablation and follow-up requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single procedure with peri-ablation care
Participants receive either concomitant thoracoscopic epicardial and catheter endocardial ablation or catheter endocardial ablation only as part of the trial intervention.
1 treatment visit (in-person) and peri-ablation monitoring
Follow-up
Duration - Up to 12 months
Participants are monitored for up to 12 months after ablation to assess freedom from atrial arrhythmias and other health outcomes.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
Actively Recruiting
Loading map...
Research Team
Z
Zhe Zheng, MD.PhD
Y
Yajie Tang, MD.PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here