NCT05610215Recruiting
Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy
Concomitant Hybrid Versus Catheter Ablation for Reinforcing Therapeutic Effect of Atrial Fibrillation With Hypertrophic Cardiomyopathy
Source: ClinicalTrials.gov · Last updated 30 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 2 Nov 2022
- Start date
- 11 Feb 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- China National Center for Cardiovascular Diseases
- NCT number
- NCT05610215
What you commit to
- Study type: Interventional
- Planned participants: 66
- From 11 Feb 2023 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant with left atrium or left atrial appendage emboli
- Concomitant with a coronary or valvular disease that indicates intervention
- Previous ablation history
- Concomitant with bacteremia or at an active phase of infection
Other illness
- Ischaemic stroke within 2 months
- End-staged kidney failure
- Anatomically not suitable for thoracoscopic surgery(history of chest surgery or radiotherapy, etc.)
Lab values
- Left ventricular ejection fraction ≤40%
Age
- Pregnant or breastfeeding, or women of childbearing age not using a reliable contraceptive method
Other
- Patients with left atrial size \>60 mm (2-dimensional echocardiography, parasternal long-axis view)
- Contraindicated to systemic anticoagulation
- Uncontrolled hyper/hypothyroidism
- Concomitantly involved in other trials
- Unwilling or unable to comply with all peri-ablation and follow-up requirements
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.