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.

ConditionParoxysmal Atrial Fibrillation (PAF)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorShanghai MicroPort EP MedTech Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

Patient age between 18 and 80 years old, male or non-pregnant female.

Confirmed diagnosis of paroxysmal atrial fibrillation requiring catheter radiofrequency ablation 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.

Disqualifiers

Post-ablation for atrial fibrillation

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

Trial design

Treatments tested in this trial

FireMagic™ Magbot Ablation Catheter 、FireMagic™ TrueForce™ Ablation Catheter

Treatment groups

20 Participants

are divided into 1 treatment group

Sponsors and collaborators

Shanghai MicroPort EP MedTech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov