Atrial Arrhythmia, Atrial Fibrillation (AF), Drug Refractory Paroxysmal Atrial Fibrillation, Paroxysmal AF
Conditions
Brief summary
This clinical investigation is intended to demonstrate safety and effectiveness of the PulseMagic™ TrueForce™ Ablation Catheter and the PulseMagic™Pulse Field Ablation (PFA) Generator, and Columbus™ 3D EP Navigation System with Pulsed Field Ablation Software for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).
Detailed description
This is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory PAF.
Interventions
DEVICEPFA Ablation catheter
Deliver PF energy using the PulseMagic™ PFA system
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥ 18 years old. * Clinically diagnosed with symptomatic paroxysmal atrial fibrillation. * Atrial fibrillation documented by surface electrocardiogram (ECG), or ambulatory electrocardiogram (including single-lead ECG recorder). * Poor response or intolerance to at least one Class I or Class III antiarrhythmic drug. * Fully informed of the treatment regimen, voluntarily signed the informed consent form, and agreed to undergo all examinations, procedures and follow-up visits specified in the study protocol.
Exclusion criteria
* Patients with a history of atrial fibrillation ablation. * Left atrial thrombus. * Left atrial anteroposterior diameter ≥ 60 mm, and left ventricular ejection fraction (LVEF) ≤ 40%. * Patients with active implantable devices in situ (e.g., cardiac pacemaker, ICD, etc.). * Women of childbearing potential who cannot use effective contraception throughout the 12-month study period after enrollment. * Atrial fibrillation caused by hyperthyroidism or other transient factors. * Patients with prior atrial septal repair, atrial septal occlusion, or left atrial myxoma. * Patients with confirmed cerebrovascular diseases within the past 6 months (including cerebral hemorrhage, stroke and transient ischaemic attack). * Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, coronary intervention, coronary artery bypass grafting, prosthetic valve replacement or repair, atrial or ventricular incision). * Patients deemed ineligible for this trial by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The success rate within 12 months after operation treatment without AADs | 12 months | Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of greater than 30 seconds duration that are documented by protocol-specified 12-lead ECG, TTM or Holter monitor (HM) devices after the index ablation procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute procedural success | after a 20 min observation period following the last ablation | Acute procedural success is defined as the isolation of each PV after a 20 min observation period following the last ablation. |
| Primary safety endpoint | Up to 7 days post ablation procedure | The incidence of primary adverse events refers to the rate of early-onset adverse events occurring within 7 days after ablation, including: vagal reflex complicated with severe bradycardia, acute coronary injury/occlusion, acute kidney injury, myocardial infarction, phrenic nerve injury/paralysis, left atrial-esophageal fistula, transient ischaemic attack, stroke/cerebrovascular accident/thromboembolism, pericarditis requiring intervention, cardiac tamponade/perforation, pneumothorax, severe vascular access complications and death. |
Countries
China
Contacts
CONTACTYan Yao
Outcome results
None listed