The goal of this prospective, observational study is to evaluate the safety and efficacy of a cardiac surgical cryoablation system for the treatment of atrial fibrillation. This study will be conducted at Fuwai Hospital in China. A total of 10 subjects with heart valve diseases (e.g., mitral, tricuspid, and aortic valve diseases) requiring surgical treatment and with atrial fibrillation will be enrolled in the study, and all of them will undergo surgical ablation using surgical cryoablation devices (cryoablation clamps and pens) with follow-up visits at 3 and 6 months after the procedure. In this study, the incidence of cardiac and cerebrovascular-related adverse events in the perioperative period and at 6 months after procedure is defined as the primary safety endpoint (all-cause mortality, stroke, systematic embolism, cardiac reoperations, heart failure requiring hospitalization, ablation-related coronary artery stenosis/occlusion, pulmonary vein stenosis, and rate of permanent pacemaker implantation.). The primary efficacy endpoint is the probability of freedom from atrial tachyarrhythmias at 6 months after the procedure. Device ease of use, technical success, ablation procedure time, and assessment of the incidence of device defects are defined as secondary endpoints.
patients with valvular disease (e.g., mitral, tricuspid, and aortic valve disease) requiring surgical intervention;
patients with atrial fibrillation who consent to cryoablation;
18-75 years of age (as of the date of signing the informed consent form);
signing the patient's informed consent.
intracardiac thrombosis;
patients with absolute contraindications to anticoagulation;
combination of other cardiac diseases requiring surgical treatment;
patients with a diagnosis of coronary artery disease (coronary artery enhancement CT or coronary angiography suggesting that any one of the three coronary vessels and their major branches has a stenosis greater than or equal to 50%);
Patients are aged between 18-75 years old, with heart valve disease requiring surgery and combined with atrial fibrillation, no previous cardiac surgery, no myocardial infarction or stroke within 3 months, no absolute contraindications to anticoagulation, no other cardiac disease that does not require surgical treatment, no diagnosis of coronary artery disease, no active infections, no serious insufficiency of the liver, kidneys, cardiopulmonary function, no thrombus in the cardiac cavity, and the internal diameter of left atrium is no more than 70mm and the left ventricular ejection fraction is not less than 50%.
Cohort
Prospective
cryoablation
DeviceThe therapeutic cryoablation agent used in this trial was liquid nitrogen with an evaporation temperature of -196°C, which was transported to the ablation pen through a vacuum line to exchange energy at the heart site to perform cryoablation.
Perioperative and 6-month postoperative cardiac and cerebrovascular-related adverse event rates
Cardiac and cerebrovascular-related adverse events included all-cause mortality, stroke, systematic embolism, repeat cardiac surgery, heart failure requiring hospitalization, ablation-related coronary artery stenosis/occlusion, pulmonary vein stenosis, and permanent pacemaker implantation rates.
The probability of freedom from atrial tachyarrhythmias at 6 months after cryoablation
The probability of freedom from atrial fibrillation, atrial flutter, and atrial tachycardia in the absence of class I/III antiarrhythmic drugs at 6 months postoperatively.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
