Tests a cryoablation device for paroxysmal atrial fibrillation
Tests a balloon cryoablation catheter in adults with paroxysmal atrial fibrillation.
Plain-language title generated from the registry record
Registry title: A Clinical Study on the Use of a Domestically Produced Cryoablation System Combined With Balloon Cryoablation Technology for the Treatment of Paroxysmal Atrial Fibrillation
Key facts
- Where
- Chengdu, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07036068, who can take part
Where in China
- West China Hospital of Sichuan UniversityChengdu, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai MicroPort EP MedTech Co., Ltd.
- Trial code
- NCT07036068
- Record updated
- 27 June 2025
- Original description
To validate the safety and efficacy of balloon cryoablation technology and the accompanying disposable intracardiac mapping electrode catheter and adjustable guide sheath for the treatment of paroxysmal atrial fibrillation.Read full original descriptionShow less
A Clinical Study on the Use of a Domestically Produced Cryoablation System Combined With Balloon Cryoablation Technology for the Treatment of Paroxysmal Atrial Fibrillation
To validate the safety and efficacy of balloon cryoablation technology and the accompanying disposable intracardiac mapping electrode catheter and adjustable guide sheath for the treatment of paroxysmal atrial fibrillation.
Inclusion: Patient age between 18 and 80 years old, male or non-pregnant female; Confirmed diagnosis of paroxysmal atrial fibrillation requiring cryoablation surgery; Fully understands the treatment plan and voluntarily signs the informed consent form, willing to undergo the examinations, surgery, and follow-up required by the plan.
Exclusion: Patients who have undergone atrial fibrillation ablation surgery; Patients who have undergone atrial septal defect repair surgery or atrial myxoma; Patients with cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack); Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision); Patients with acute or severe systemic infection; Patients with severe liver or kidney disease; Patients with a significant tendency to bleed or haematological disorders; Patients with malignant tumours or end-stage diseases; Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%; Reproductive-age patients who cannot use effective contraception within 12 months of enrolment; Left atrial thrombus; Patients deemed ineligible for this trial by the investigator.