Clinical trial NCT05731882: First in Man Study of Left Atrial Appendage Pulsed Field Ablation Occluder
Official title: First in Man Study to Evaluate Safety and Efficacy of Left Atrial Appendage Pulsed Field Ablation Occluder for Simultaneous Pulsed Field Ablation and Mechanical Closure of the Left Atrial Appendage in Patients With Nonvalvular Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nonvalvular Atrial Fibrillation
Lead sponsor: Hangzhou Dinova EP Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-02-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Technical success rate
timeFrame: immediately after the procedure
measure: The incidence of major adverse events (MAEs) related to devices or procedures 3 months after procedure
timeFrame: within 3 months after procedure
Secondary outcomes:
measure: Ablation efficiency including total procedure time, catheter dwell time, total ablation time and total X-ray exposure time
timeFrame: immediately after the procedure
measure: Left atrial appendage closure rate 12 months after procedure
timeFrame: within 12 months after procedure
measure: Incidence of ischemic stroke within 12 months after procedure (event/patient-year).
timeFrame: within 12 months after procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
Study officials:
References: