New device for treating atrial fibrillation

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

This study is testing a new device that combines two treatments for people with atrial fibrillation who can't take blood thinners to see if it works safely and effectively.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Hangzhou Dinova EP Technology Co., Ltd (Industry-sponsored)
• Locations: 3 sites (Beijing, Beijing and 2 other locations)
• Trial ID: NCT05731882 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the E-SeaLA device, which combines pulsed field ablation and mechanical closure of the Left Atrial Appendage in patients with non-valvular atrial fibrillation. The study aims to assess the safety and efficacy of this innovative approach in a first-in-man setting. Participants will be monitored for their response to the treatment and any potential adverse effects. The trial includes patients who are not suitable for long-term anticoagulant therapy, providing a new option for this population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 diagnosed with non-valvular atrial fibrillation and unsuitable for long-term oral anticoagulant therapy.

Not a fit: Patients with secondary atrial fibrillation or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could offer a safer and more effective treatment option for patients with non-valvular atrial fibrillation who cannot use traditional anticoagulants.

How similar studies have performed: While this approach is novel, similar studies exploring pulsed field ablation techniques have shown promise, indicating potential for success.

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.

Where this trial is running

Beijing, Beijing and 2 other locations

• Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)
• Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (Recruiting)
• General Hospital of Northern Theater Command — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Study coordinator: Min Tang, professor

Conditions Nonvalvular Atrial Fibrillation