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A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia (PSVT)

Primary Purpose

Paroxysmal Supraventricular Tachycardia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter
Sponsored by
Shanghai MicroPort EP MedTech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Supraventricular Tachycardia focused on measuring PFA, PSVT, AVNRT, AVRT

Eligibility Criteria

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

Inclusion Criteria: 18 years old ≤ age ≤ 80 years old, regardless of gender Patients with symptomatic paroxysmal supraventricular tachycardia PSVT (AVNRT or AVRT) documented by ECG, Holter or electrophysiological examination Recurrent episodes of disease prior to enrollment Fully understand the treatment protocol and voluntarily sign an informed consent form, willing to undergo the tests, procedures and follow-ups required by the protocol Exclusion Criteria: Previous failure or recurrence of radiofrequency ablation Left ventricular ejection fraction (LVEF) ≤ 40% Combined with atrial flutter or atrial fibrillation Combination of thromboembolic disease Women who are breastfeeding, pregnant or planning to become pregnant during the study period Carrying active implants in the body (e.g., pacemakers, ICDs, etc.) Patients with second-degree (type II) or third-degree atrioventricular block NYHA Class III-IV cardiac function [Appendix 1] Patients with congenital heart disease (excluding atrial septal defect and patent foramen ovale) Patients with definite acute cerebrovascular disease (including cerebral hemorrhage, stroke, transient ischemic attack) within the last 1 month cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy) Acute or severe systemic infection Patients with severe liver and kidney diseases, malignant tumors and end-stage diseases Patients with significant bleeding tendency, hypercoagulable state and serious hematologic disorders Patients who have participated or are participating in other clinical trials within 3 months before enrollment Patients who have other conditions that the investigator considers inappropriate for participation in this trial.

Sites / Locations

  • Ningbo First Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experiment group

Arm Description

Patients treated with PFA catheter.

Outcomes

Primary Outcome Measures

acute ablation success rate
The Primary Endpoint for efficacy is the number of subjects where ablation of each PSVT resulted in confirmation of electrical isolation of the PSVT 15 minutes following by catheter mapping and ECG to determine acute ablation success rate

Secondary Outcome Measures

Rate of Treatment Success at 1-Month Post-Procedure
Refers to the postoperative phase after 1 months follow-up after process,by ECG, Holter, or Heart rate monitoring method based on equivalent confirmed that there are no PSVT events account for the number of participants into the group of the proportion of the total number.
Rate of Treatment Success at 3-Month Post-Procedure
Refers to the postoperative phase after 3 months follow-up after process,by ECG, Holter, or Heart rate monitoring method based on equivalent confirmed that there are no PSVT events account for the number of participants into the group of the proportion of the total number.
Rate of Treatment Success at 6-Month Post-Procedure
Refers to the postoperative phase after 6 months follow-up after process,by ECG, Holter, or Heart rate monitoring method based on equivalent confirmed that there are no PSVT events account for the number of participants into the group of the proportion of the total number.
Evaluation of Force Sensing Pulsed Field Ablation Catheter
Evaluation of Surgery start time, Surgery end time, X-ray imaging time, Ablation voltage, Ablation modelm, Ablation sites ,Whether the catheter is in place well, Controllable degree of catheter bend adjustment, Stability of catheter positioning signals, Whether there is interference in the discharge of the conduit, et al.
Evaluation of Pulse Ablation equipment
Whether the software can realize each set function, Whether the interface friendly and easy to operate, No abnormal software crash during the operation, et al.

Full Information

First Posted
March 17, 2023
Last Updated
October 7, 2023
Sponsor
Shanghai MicroPort EP MedTech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05820035
Brief Title
A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia
Acronym
PSVT
Official Title
A Multicenter Clinical Study of Pulsed Electric Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter for the Treatment of Paroxysmal Supraventricular Tachycardia Under the Guidance of Columbus 3D EP Navigation System
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai MicroPort EP MedTech Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study was to explore the safety and efficacy of a Pulsed Field Ablation(PFA) Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia(PSVT)
Detailed Description
The primary endpoint of this sutdy is the actue ablation success rate for all subjects, other endpoints include treatment success rate within 6 months after surgery, evaluation of equipment and cather. The primary safety endpoint for this study is the incidence of early-onset (within 7 days of the PFA ablation procedure) primary adverse events (AEs), ohter satety endpoints are incidence of AEs associated with the study devices and serious adverse events(SAEs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Supraventricular Tachycardia
Keywords
PFA, PSVT, AVNRT, AVRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multicenter, single-group target value, interventional, non-inferiority study
Masking
None (Open Label)
Allocation
N/A
Enrollment
151 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiment group
Arm Type
Experimental
Arm Description
Patients treated with PFA catheter.
Intervention Type
Device
Intervention Name(s)
Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter
Intervention Description
All subjects will be ablated using the Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the management of their Paroxysmal Supraventricular Tachycardia
Primary Outcome Measure Information:
Title
acute ablation success rate
Description
The Primary Endpoint for efficacy is the number of subjects where ablation of each PSVT resulted in confirmation of electrical isolation of the PSVT 15 minutes following by catheter mapping and ECG to determine acute ablation success rate
Time Frame
15 minutes post ablation
Secondary Outcome Measure Information:
Title
Rate of Treatment Success at 1-Month Post-Procedure
Description
Refers to the postoperative phase after 1 months follow-up after process,by ECG, Holter, or Heart rate monitoring method based on equivalent confirmed that there are no PSVT events account for the number of participants into the group of the proportion of the total number.
Time Frame
Refers to the postoperative phase after 1 months postoperatively
Title
Rate of Treatment Success at 3-Month Post-Procedure
Description
Refers to the postoperative phase after 3 months follow-up after process,by ECG, Holter, or Heart rate monitoring method based on equivalent confirmed that there are no PSVT events account for the number of participants into the group of the proportion of the total number.
Time Frame
Refers to the postoperative phase after 3 months postoperatively
Title
Rate of Treatment Success at 6-Month Post-Procedure
Description
Refers to the postoperative phase after 6 months follow-up after process,by ECG, Holter, or Heart rate monitoring method based on equivalent confirmed that there are no PSVT events account for the number of participants into the group of the proportion of the total number.
Time Frame
Refers to the postoperative phase after 6 months postoperatively
Title
Evaluation of Force Sensing Pulsed Field Ablation Catheter
Description
Evaluation of Surgery start time, Surgery end time, X-ray imaging time, Ablation voltage, Ablation modelm, Ablation sites ,Whether the catheter is in place well, Controllable degree of catheter bend adjustment, Stability of catheter positioning signals, Whether there is interference in the discharge of the conduit, et al.
Time Frame
immediately post ablation
Title
Evaluation of Pulse Ablation equipment
Description
Whether the software can realize each set function, Whether the interface friendly and easy to operate, No abnormal software crash during the operation, et al.
Time Frame
immediately post ablation
Other Pre-specified Outcome Measures:
Title
primary adverse events
Description
The primary safety endpoint for this study is the incidence of early-onset (within 7 days of the PFA procedure) primary adverse events (AEs).
Time Frame
Refers to the postoperative phase within 7days postoperatively
Title
Incidence of adverse events and serious adverse events associated with the study device
Description
Incidence of adverse events and serious adverse events associated with the study device
Time Frame
Refers to the postoperative phase 6 months postoperatively

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: 18 years old ≤ age ≤ 80 years old, regardless of gender Patients with symptomatic paroxysmal supraventricular tachycardia PSVT (AVNRT or AVRT) documented by ECG, Holter or electrophysiological examination Recurrent episodes of disease prior to enrollment Fully understand the treatment protocol and voluntarily sign an informed consent form, willing to undergo the tests, procedures and follow-ups required by the protocol Exclusion Criteria: Previous failure or recurrence of radiofrequency ablation Left ventricular ejection fraction (LVEF) ≤ 40% Combined with atrial flutter or atrial fibrillation Combination of thromboembolic disease Women who are breastfeeding, pregnant or planning to become pregnant during the study period Carrying active implants in the body (e.g., pacemakers, ICDs, etc.) Patients with second-degree (type II) or third-degree atrioventricular block NYHA Class III-IV cardiac function [Appendix 1] Patients with congenital heart disease (excluding atrial septal defect and patent foramen ovale) Patients with definite acute cerebrovascular disease (including cerebral hemorrhage, stroke, transient ischemic attack) within the last 1 month cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy) Acute or severe systemic infection Patients with severe liver and kidney diseases, malignant tumors and end-stage diseases Patients with significant bleeding tendency, hypercoagulable state and serious hematologic disorders Patients who have participated or are participating in other clinical trials within 3 months before enrollment Patients who have other conditions that the investigator considers inappropriate for participation in this trial.
Facility Information:
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315000
Country
China

12. IPD Sharing Statement

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A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia

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