Paroxysmal Atrial Fibrillation (PAF)
Conditions
Keywords
PFA, PeAF, PFA/RF
Brief summary
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
DEVICEIceMagic™ 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.
Sponsors
Shanghai MicroPort EP MedTech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient age between 18 and 80 years old, male or non-pregnant female. 2. Confirmed diagnosis of paroxysmal atrial fibrillation requiring cryoablation surgery. 3. 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
1. Patients who have undergone atrial fibrillation ablation surgery 2. Reproductive-age patients who cannot use effective contraception within 12 months of enrolment 3. Left atrial size ≥50 mm, left ventricular ejection fraction ≤40% 4. Left atrial thrombus 5. Patients who have undergone atrial septal defect repair surgery or atrial myxoma 6. Patients with cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack) 7. 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) 8. Patients with acute or severe systemic infection 9. Patients with severe liver or kidney disease 10. Patients with a significant tendency to bleed or haematological disorders 11. Patients with malignant tumours or end-stage diseases 12. Patients deemed ineligible for this trial by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Three-month follow-up success rate after surgery | Three months after surgery | Postoperative 3-month treatment success rate: Specifically refers to the proportion of participants who, during the 3-month follow-up period post-surgery (after the washout period), did not experience any episodes of atrial fibrillation/atrial flutter/atrial tachycardia lasting ≥30 seconds, as confirmed by electrocardiogram (ECG), Holter monitoring, or equivalent rhythm monitoring methods (including single-lead ECG), without the use of Class I or Class III antiarrhythmic drugs, relative to the total number of enrolled participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate ablation success rate | On the 1 day of the surgery | This refers to the proportion of subjects who achieved electrical isolation after surgery among the total number of patients enrolled in the study. The verification method involves waiting for 20 minutes after successful pulmonary vein electrical isolation and then reconfirming pulmonary vein conduction block. |
Countries
China
Contacts
Primary ContactKaijun K Cui, PhD
Outcome results
None listed