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

Primary Purpose

Nonvalvular Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
E-SeaLA, CardioPulse PFA system
Sponsored by
Hangzhou Dinova EP Technology Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonvalvular Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; Acute systemic infection; Severe lung disease, pulmonary hypertension or any lung disease involving abnormal blood gases or severe breathing difficulties; Presence of wall thrombosis, tumors or other abnormalities that interfere with vascular puncture or catheter operation; Female patients who are pregnant, lactating, or unable to use contraception during the study; patients have participated in clinical trials of other drugs or devices during the same period; patient's life expectancy is less than 12 months; Abnormalities or diseases that the investigator believes should be excluded from the scope of enrollment in this study.

Sites / Locations

  • Fuwai Hospital, Chinese Academy of Medical SciencesRecruiting
  • Fuwai Central China Cardiovascular HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Catheter ablation+E-SeaLATM

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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)
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.

Full Information

First Posted
January 30, 2023
Last Updated
May 9, 2023
Sponsor
Hangzhou Dinova EP Technology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05731882
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Dinova EP Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonvalvular Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Catheter ablation+E-SeaLATM
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
E-SeaLA, CardioPulse PFA system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Technical success rate
Description
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.
Time Frame
immediately after the procedure
Title
The incidence of major adverse events (MAEs) related to devices or procedures 3 months after procedure
Description
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.
Time Frame
within 3 months after procedure
Secondary Outcome Measure Information:
Title
Ablation efficiency including total procedure time, catheter dwell time, total ablation time and total X-ray exposure time
Description
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).
Time Frame
immediately after the procedure
Title
Left atrial appendage closure rate 12 months after procedure
Description
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)
Time Frame
within 12 months after procedure
Title
Incidence of ischemic stroke within 12 months after procedure (event/patient-year).
Description
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.
Time Frame
within 12 months after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; Acute systemic infection; Severe lung disease, pulmonary hypertension or any lung disease involving abnormal blood gases or severe breathing difficulties; Presence of wall thrombosis, tumors or other abnormalities that interfere with vascular puncture or catheter operation; Female patients who are pregnant, lactating, or unable to use contraception during the study; patients have participated in clinical trials of other drugs or devices during the same period; patient's life expectancy is less than 12 months; Abnormalities or diseases that the investigator believes should be excluded from the scope of enrollment in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Tang, professor
Phone
+86037158680341
Email
dinova_ep@dnaeps.com
Facility Information:
Facility Name
Fuwai Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Tang, professor
Email
dinova_ep@dnamedtech.com
Facility Name
Fuwai Central China Cardiovascular Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianqing Wang, professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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