NCT06703528Not yet recruiting
An Exploratory Clinical Study to Evaluate the Safety and Efficacy of a Cardiac Surgical Cryoablation System for the Treatment of Atrial Fibrillation
Cryoablation System with Liquid Nitrogen for the Treatment of Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 25 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 10 (estimated)
- First submitted
- 16 Nov 2024
- Start date
- Jun 2025
- Primary completion date
- Jun 2026
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- Atrial fibrillation
- NCT number
- NCT06703528
What you commit to
- Study type: Observational
- Planned participants: 10
- From Jun 2025 to the primary completion date, Jun 2026
- No sites listed in no 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
- patients with a prior history of cardiac surgery;
Other illness
- intracardiac thrombosis;
- 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 with generalized malignant disease or severe insufficiency of liver, kidney, heart and lung functions;
- patients with current active infection;
- patients with myocardial infarction within the last 3 months;
- patients who have suffered a stroke within the last 3 months;
Lab values
- left ventricular ejection fraction (LVEF) \<50%;
Other
- patients with absolute contraindications to anticoagulation;
- pregnant and lactating patients;
- patients with an anterior-posterior left atrial diameter greater than 70 mm;
- patients who are not expected to complete the 6-month postoperative follow-up;
- those who are participating in other clinical trials and have not met the primary endpoint;
- those who, in the opinion of the investigator, are not suitable for participation in this clinical study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.