A Clinical Study on the Use of a Domestically Produced Three-dimensional Cardiac Electrophysiological Mapping System Combined With Pressure Monitoring Technology and Star Mapping Technology for the Treatment of Paroxysmal Atrial Fibrillation. (paroxysmal at)

MicroPort

Status: Not yet enrolling

Conditions: Paroxysmal Atrial Fibrillation (PAF)

Treatments: Device: FireMagic™ Magbot Ablation Catheter 、FireMagic™ TrueForce™ Ablation Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT07039032

A.1

Details and patient eligibility

About

Validating the safety and efficacy of pressure monitoring technology and star-shaped marking technology for the treatment of paroxysmal atrial fibrillation

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Single-centre, post-marketing study

Experimental group

Description:

Validating the safety and efficacy of pressure monitoring technology and star-shaped marking technology for the treatment of paroxysmal atrial fibrillation

Treatment:

Device: FireMagic™ Magbot Ablation Catheter 、FireMagic™ TrueForce™ Ablation Catheter