Not yet recruiting NCT07036068
A Clinical Study on the Use of a Domestically Produced Cryoablation System Combined With Balloon Cryoablation Technology for the Treatment of Paroxysmal Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IceMagic™ CryoAblation Catheter.
- Who it may be relevant to
- Registry conditions: Paroxysmal Atrial Fibrillation (PAF). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device IceMagic™ CryoAblation Catheter
IceMagic™ CryoAblation Catheter is available in two diameters: 23 mm and 28 mm. Each diameter has two types of balloon outer surfaces: with or without multi-channel tissue temperature measurement function. The catheter length is 140 cm, and the tube diameter is 10.5 F. Doctors can choose according to the size of the target pulmonary vein.
Primary outcome measures
- Three-month follow-up success rate after surgery [Time frame: Three months after surgery]
Secondary outcome measures (1)
- Immediate ablation success rate [Time frame: On the 1 day of the surgery]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Patients who have undergone atrial fibrillation ablation surgery
- Reproductive-age patients who cannot use effective contraception within 12 months of enrolment
- Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%
- Left atrial thrombus
- 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
- Patients deemed ineligible for this trial by the investigator
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China Hospital of Sichuan University — Chengdu
Identifiers
NCT: NCT07036068 · West China Hospital（Sichuan）