First in Man Study of Left Atrial Appendage Pulsed Field Ablation Occluder

Hangzhou DiNovA EP Technology

Status: Enrolling

Conditions: Nonvalvular Atrial Fibrillation

Treatments: Device: E-SeaLA, CardioPulse PFA system

Study type: Interventional

Funder types: Industry

Identifiers

NCT05731882

E-SeaLA FIM 01

Details and patient eligibility

About

This is the first in man study of E-SeaLATM developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can achieve pulsed field ablation and mechanical closure of the Left Atrial Appendage simultaneously, this study aims to initially verify the safety and efficacy of the device.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The age of the patient is 18~80 years old;
2. patients diagnosed with non-valvular atrial fibrillation (at least 1 episode of atrial fibrillation recorded on ECG or Holter in the 12 months prior to enrollment);
3. CHA2DS2-VASC score: male≥ 2, female≥ 3;
4. patients are not suitable for long-term oral anticoagulant therapy (any of the following): (1) not suitable for long-term standardized anticoagulation therapy; (2) stroke or embolism still occurs on the basis of long-term standardized anticoagulation therapy; (3) HAS-BLED score≥ 3 points; (4) need to be treated with antiplatelet drugs; (5) unwillingness to undergo long-term anticoagulant therapy;
5. Be able to understand the purpose of the study, voluntarily participate in the study, sign the informed consent form by the subject himself or her legal representative, and be willing to complete the follow-up in accordance with the requirements of the program.

Exclusion criteria

1. Atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible factors;
2. Left atrial appendage depth < 15mm, left atrial appendage anchor area < 10mm or >33mm;
3. Left atrial diameter≥ 65mm;
4. Imaging examination shows left atrium or left atrial appendage thrombosis;
5. Severe structural heart disease (such as moderate to severe aortic valve, mitral stenosis or regurgitation);
6. Left ventricular ejection fraction <35%, or New York College of Cardiology class III or IV;
7. Refractory hypertension (blood pressure persists > 180/110mmHg after treatment);
8. Patients with previous patent foramen ovale closure, atrial septal defect closure or repair;
9. Patients with previous left atrial appendage occlusion or left atrial appendage closure;
10. Patients with previous valve repair, prosthetic valve implantation or replacement;
11. Patients who have implanted devices such as implantable cardioverter defibrillator(ICD), cardiac resynchronization therapy(CRT) or pacemaker or have an implantation plan within 12 months after procedure;
12. Patients with clinically symptomatic carotid artery stenosis, or patients who have undergone carotid stenting or carotid endarterectomy in the past 6 months;
13. Patients with a history of myocardial infarction in the past 6 months, or who have undergone coronary artery bypass grafting or percutaneous coronary intervention;
14. Recorded thromboembolic events (including transient ischemic attack) in the past 30 days;
15. Serum creatinine greater than 2 times the upper limit of normal, or history of renal dialysis;
16. Acute systemic infection;
17. Severe lung disease, pulmonary hypertension or any lung disease involving abnormal blood gases or severe breathing difficulties;
18. Presence of wall thrombosis, tumors or other abnormalities that interfere with vascular puncture or catheter operation;
19. Female patients who are pregnant, lactating, or unable to use contraception during the study;
20. patients have participated in clinical trials of other drugs or devices during the same period;
21. patient's life expectancy is less than 12 months;
22. Abnormalities or diseases that the investigator believes should be excluded from the scope of enrollment in this study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Catheter ablation+E-SeaLATM

Experimental group

Treatment:

Device: E-SeaLA, CardioPulse PFA system