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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Nonvalvular Atrial Fibrillation
• Intervention / Treatment: Device: E-SeaLA, CardioPulse PFA system

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Tang, professor; Phone Number: +86037158680341; Email: dinova_ep@dnaeps.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Fuwai Hospital, Chinese Academy of Medical Sciences
      • Contact: Min Tang, professor; Email: dinova_ep@dnamedtech.com
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Fuwai Central China Cardiovascular Hospital
      • Contact: Xianqing Wang, professor
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • Recruiting
      • General Hospital of Northern Theater Command
      • Contact: Zulu Wang, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Catheter ablation+E-SeaLATM	Device: E-SeaLA, CardioPulse PFA system; First, pulmonary vein isolation(PVI) was performed with the novel hex spline PFA ablation catheter( CardioPulseTM PFA system, Hangzhou Dinova EP Technology Co., Ltd), then, pulsed field ablation and mechanical closure of the left atrial appendage were achieved by E-SeaLATM(Hangzhou Dinova EP Technology Co., Ltd) implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	Technical success means that the pulmonary vein and left atrial appendage(LAA) remain electrical isolation 20 minutes after ablation, and the per-device leaks≤ 3 mm after E-SeaLA LAA pulsed field ablation(PFA) occluder implantation.	immediately after the procedure
The incidence of major adverse events (MAEs) related to devices or procedures 3 months after procedure	MAE includes death, myocardial infarction, stroke or transient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve palsy, systemic embolism, pericarditis, pericardial effusion/cardiac tamponade, atrial esophageal fistula, severe vascular access complications, device migration, and device embolization.	within 3 months after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ablation efficiency including total procedure time, catheter dwell time, total ablation time and total X-ray exposure time	Total procedure time (defined as the total time from initial femoral venipuncture to final catheter removal), catheter dwell time (time between the pulsed field ablation catheter entering the left atrium and its withdrawal from the left atrium), total ablation time (including total PVI ablation time, total LAA ablation time), total X-ray exposure time (the total time of X-ray imaging of the catheter).	immediately after the procedure
Left atrial appendage closure rate 12 months after procedure	after occlusion device implantation, no forward or reverse blood flow through the occluder confirmed by ultrasound, residual forward or reverse blood flow at the edge of the occluder ≤3mm, peri-device leaks ≥grade 3)	within 12 months after procedure
Incidence of ischemic stroke within 12 months after procedure (event/patient-year).	Ischemic stroke refers to the loss of neurological function caused by transient ischemic attack, cerebral thrombosis or cerebral embolism caused by the lesions of the brain itself and/or systemic blood circulation disorders leading to cerebral blood supply disorders. Ischemic stroke is defined as a modified Rankin score (mRS) ≥2 90 days after stroke onset.	within 12 months after procedure

Collaborators and Investigators

• Sponsor: Hangzhou Dinova EP Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: E-SeaLA FIM 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No