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

NCT05731882 | Unknown

• 1 other identifier: E-SeaLA FIM 01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Nonvalvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Ablation efficiency including total procedure time, catheter dwell time, total ablation time and total X-ray exposure time

  immediately after the procedure

• Left atrial appendage closure rate 12 months after procedure

  within 12 months after procedure

• Incidence of ischemic stroke within 12 months after procedure (event/patient-year).

  within 12 months after procedure

Study Arms (1)

Catheter ablation+E-SeaLATM

EXPERIMENTAL

Device: E-SeaLA, CardioPulse PFA system

Interventions

E-SeaLA, CardioPulse PFA system DEVICE

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.

Catheter ablation+E-SeaLATM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age of the patient is 18\~80 years old;
• 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);
• CHA2DS2-VASC score: male≥ 2, female≥ 3;
• 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;
• 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.

You may not qualify if:

• Atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible factors;
• Left atrial appendage depth \< 15mm, left atrial appendage anchor area \< 10mm or \>33mm;
• Left atrial diameter≥ 65mm;
• Imaging examination shows left atrium or left atrial appendage thrombosis;
• Severe structural heart disease (such as moderate to severe aortic valve, mitral stenosis or regurgitation);
• Left ventricular ejection fraction \<35%, or New York College of Cardiology class III or IV;
• Refractory hypertension (blood pressure persists \> 180/110mmHg after treatment);
• Patients with previous patent foramen ovale closure, atrial septal defect closure or repair;
• Patients with previous left atrial appendage occlusion or left atrial appendage closure;
• Patients with previous valve repair, prosthetic valve implantation or replacement;
• 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;
• Patients with clinically symptomatic carotid artery stenosis, or patients who have undergone carotid stenting or carotid endarterectomy in the past 6 months;
• Patients with a history of myocardial infarction in the past 6 months, or who have undergone coronary artery bypass grafting or percutaneous coronary intervention;
• Recorded thromboembolic events (including transient ischemic attack) in the past 30 days;
• Serum creatinine greater than 2 times the upper limit of normal, or history of renal dialysis;

Sponsors & Collaborators

• Hangzhou Dinova EP Technology Co., Ltd: lead

Study Sites (3)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

RECRUITING

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

RECRUITING

Central Study Contacts

Min Tang, professor

CONTACT

+86037158680341; dinova_ep@dnaeps.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 16, 2023
• Study Start: July 17, 2022
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

CN (3)