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Clinical Trial of the Pulse Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 11 Centers in China

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pulse ablation catheter
Sponsored by
Shenzhen Pulsecare Medical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Pulse Field Ablation Catheter

Eligibility Criteria

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

Inclusion Criteria: Subjects must meet all of the following conditions to be enrolled: 18 to 80 years of age, gender is not limited Patients with a clinical diagnosis of paroxysmal atrial fibrillation confirmed by ECG Patients who were to undergo catheter ablation of atrial fibrillation Those who agreed to participate in this study and voluntarily signed the informed consent form Exclusion Criteria: Subjects were excluded if they met one of the following conditions: Patients who have had ablation for atrial fibrillation Patients with left ventricular ejection fraction (LVEF) <35%. Patients with an anteroposterior diameter of the left atrium (echocardiography) >50 mm Preoperative detection of a definite thrombus in the left atrium Patients with cardiac function class (NYHA) III-IV Patients with second-degree (type II) or third-degree atrioventricular block Patients with significant congenital heart defects (including atrial septal defect, ventricular septal defect, arterial ductus arteriosus, transposition ofthe grea, or severe pulmonicvalve, but not including foramen ovale persistens) Patients with implanted prosthetic valves or the presence of severe heart valve disease, who are not suitable for ablation for atrial fibrillation Patients with artificial cardiac pacemaker or implantable cardioverter defibrillator (ICDs) Patients diagnosed with hypertrophic obstructive cardiomyopathy, chronic obstructive pulmonary disease, or myxoma Patients who need to undergo left atrial appendage closure in the same surgery Patients found to have atrial flutter preoperatively and judged unsuitable by the investigators, or patients with atrial parasystolic tachycardia (non-pulmonary venous origin) or paroxysmal supraventricular tachycardia Patients with active systemic infection who are judged unsuitable for interventional therapy by the investigators Patients with systemic bleeding tendencies that preclude surgery or patients with renal failure undergoing hemodialysis Patients who have had a myocardial infarction or any interventional/open heart surgery (except coronary angiography) within 3 months Patients who have had a stroke (except asymptomatic stroke) or transient ischemic attack within 3 months Patients with significant contraindications to interventional procedures or with an expected survival of <1 year who are judged by the investigator to be incapable of undergoing ablative procedures Females who are pregnant or breastfeeding or who are planning to have children during the study period Patients who have participated in a clinical trial of another drug or medical device within 3 months Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial

Sites / Locations

  • the Second Affiliated Hospital of Sun Yat-sen University (Sun Yat-sen Memorial Hospital)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental group

Arm Description

Each subject underwent pulse ablation catheter ablation

Outcomes

Primary Outcome Measures

Immediate success rate of surgery
Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100%
Treatment success rate
Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs. Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100%

Secondary Outcome Measures

numer of cases of the the occurrence of hospitalization or emergency treatment
The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery;
Device performance evaluation
Device defects of the clinical trial equipment

Full Information

First Posted
September 10, 2023
Last Updated
September 10, 2023
Sponsor
Shenzhen Pulsecare Medical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06039722
Brief Title
Clinical Trial of the Pulse Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 11 Centers in China
Official Title
Prospective, Multicenter, Single-arm Clinical Trial Evaluating the Safety and Efficacy of the Pulse Field Ablation System in Combination With the Pulse Field Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
August 17, 2024 (Anticipated)
Study Completion Date
August 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Pulsecare Medical 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 study is expected to include 166 subjects and Conducted at 11 research centers;The expected 12 month treatment success rate of using research instruments is 65%. Principle evaluation indexes: Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100% Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs. Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100% Secondary evaluation indexes: The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery; Device performance evaluation; Safety evaluation indexes: The occurrence of death, stroke, or transient ischemic attack; The occurrence of surgical related complications, such as vascular puncture complications (pseudoaneurysm, arteriovenous fistula, etc.), heart perforation, atrial esophageal fistula, phrenic nerve injury, pulmonary vein stenosis (symptomatic), etc; Clinically significant vital signs and related examinations; The occurrence of other adverse events and serious adverse events during the trial period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Pulse Field Ablation Catheter

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Each subject underwent pulse ablation catheter ablation
Intervention Type
Device
Intervention Name(s)
Pulse ablation catheter
Intervention Description
Pulse ablation catheter is used to ablate the junction of left atrium and pulmonary vein, removing pulmonary vein potential
Primary Outcome Measure Information:
Title
Immediate success rate of surgery
Description
Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100%
Time Frame
After surgery 20 minutes later
Title
Treatment success rate
Description
Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs. Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100%
Time Frame
Between 3 months and 12 months after ablation
Secondary Outcome Measure Information:
Title
numer of cases of the the occurrence of hospitalization or emergency treatment
Description
The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery;
Time Frame
Between 0 months and 12 months after ablation
Title
Device performance evaluation
Description
Device defects of the clinical trial equipment
Time Frame
surgery period

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: Subjects must meet all of the following conditions to be enrolled: 18 to 80 years of age, gender is not limited Patients with a clinical diagnosis of paroxysmal atrial fibrillation confirmed by ECG Patients who were to undergo catheter ablation of atrial fibrillation Those who agreed to participate in this study and voluntarily signed the informed consent form Exclusion Criteria: Subjects were excluded if they met one of the following conditions: Patients who have had ablation for atrial fibrillation Patients with left ventricular ejection fraction (LVEF) <35%. Patients with an anteroposterior diameter of the left atrium (echocardiography) >50 mm Preoperative detection of a definite thrombus in the left atrium Patients with cardiac function class (NYHA) III-IV Patients with second-degree (type II) or third-degree atrioventricular block Patients with significant congenital heart defects (including atrial septal defect, ventricular septal defect, arterial ductus arteriosus, transposition ofthe grea, or severe pulmonicvalve, but not including foramen ovale persistens) Patients with implanted prosthetic valves or the presence of severe heart valve disease, who are not suitable for ablation for atrial fibrillation Patients with artificial cardiac pacemaker or implantable cardioverter defibrillator (ICDs) Patients diagnosed with hypertrophic obstructive cardiomyopathy, chronic obstructive pulmonary disease, or myxoma Patients who need to undergo left atrial appendage closure in the same surgery Patients found to have atrial flutter preoperatively and judged unsuitable by the investigators, or patients with atrial parasystolic tachycardia (non-pulmonary venous origin) or paroxysmal supraventricular tachycardia Patients with active systemic infection who are judged unsuitable for interventional therapy by the investigators Patients with systemic bleeding tendencies that preclude surgery or patients with renal failure undergoing hemodialysis Patients who have had a myocardial infarction or any interventional/open heart surgery (except coronary angiography) within 3 months Patients who have had a stroke (except asymptomatic stroke) or transient ischemic attack within 3 months Patients with significant contraindications to interventional procedures or with an expected survival of <1 year who are judged by the investigator to be incapable of undergoing ablative procedures Females who are pregnant or breastfeeding or who are planning to have children during the study period Patients who have participated in a clinical trial of another drug or medical device within 3 months Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial
Facility Information:
Facility Name
the Second Affiliated Hospital of Sun Yat-sen University (Sun Yat-sen Memorial Hospital)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Trial of the Pulse Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 11 Centers in China

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