Paroxysmal Atrial Fibrillation (PAF)
Conditions
Keywords
PFA, PeAF, PFA/RF
Brief summary
Validating the safety and efficacy of pressure monitoring technology and star-shaped marking technology for the treatment of paroxysmal atrial fibrillation
Detailed description
This trial will select appropriate clinical cases at clinical centres, where authorised investigators will perform ablation surgery for paroxysmal atrial fibrillation using the trial product. Indicators such as immediate ablation success rate and treatment success rate within three months post-surgery will be collected.
Interventions
DEVICEFireMagic™ Magbot Ablation Catheter 、FireMagic™ TrueForce™ Ablation Catheter
1. The pressure-sensing catheter primarily consists of electrodes, a catheter body, and a control handle. The catheter body comprises a high-torque body and a flexible tip, divided into an adjustable bending segment and a main segment. By pushing or pulling the handle at the proximal end of the catheter, the internal traction wire at the catheter tip can be activated to control the bending of the tip. The adjustable bending segment is fixed with four electrodes at regular intervals, including one tip electrode and three ring electrodes. 2. The disposable star-shaped magnetoelectric positioning catheter is specifically designed for cardiac electrophysiological mapping. The distal end of the catheter has multiple 3F branches, each with multiple platinum-iridium electrodes for collecting cardiac electrophysiological signals. The distal end of the catheter features an adjustable bend design; pushing the button on the catheter forward will cause the distal end of the catheter to bend.
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 catheter radiofrequency ablation 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. Post-ablation for atrial fibrillation 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. History of atrial septal defect repair or atrial myxoma 6. History of cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack) 7. History of 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 significant bleeding tendencies 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 | Postoperative 3-month | Postoperative 3-month treatment success rate: Specifically refers to the proportion of participants who, during the 3-month follow-up period (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 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 ContactQing NA Yang, PhD
Outcome results
None listed