Back to resultsPulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）
Primary Purpose
Paroxysmal Supraventricular Tachycardia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Supraventricular Tachycardia focused on measuring PSVT, PFA, AVNRT, AVRT
Eligibility Criteria
Inclusion Criteria: Patients with symptomatic paroxysmal supraventricular tachycardia including:Atrioventricular nodal re-entrant tachycardia, Atrioventricular arrhythmias; Willingness to undergo an evaluation to validate the requirements of the protocol. Voluntary signed informed consent and willingness to undergo the tests and procedures required by the protocol. Exclusion Criteria: Patients with intracardiac thrombosis at the time of study or with a history of thromboembolic event within past 3 months History of any cardiac surgery Presence of any implantation, such as artificial valves, permanent pacemakers, etc Patients with active systemic infections Any condition contraindicating septal puncture or retrograde transaortic approach for procedures Any condition contraindicating heparin or indobufen Patients with advanced malignant tumor Any woman known to be pregnant or breastfeeding 8. Unwilling or unable to comply fully with study procedures and follow-up 9. Unable to provide own informed consent
Sites / Locations
- Ningbo First Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Non-randomized
Arm 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
Outcomes
Primary Outcome Measures
Immediate 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 immediate 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 2-Month Post-Procedure
Refers to the postoperative phase after 2 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 catheter operation performance;Catheter ablation parameters
Evaluation of Pulse Ablation equipment
System software operability; System operation stability; Hardware connection validity
Full Information
NCT ID
NCT05770921
First Posted
January 30, 2023
Last Updated
October 7, 2023
Sponsor
Ningbo No. 1 Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05770921
Brief Title
Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）
Official Title
An Exploratory Study of Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter Guided by Columbus 3D EP Navigation System in the Ablation Treatment of Paroxysmal Supraventricular Tachycardia（PSVT）
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
July 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ningbo No. 1 Hospital
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 Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia.
Detailed 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 the last index PFA application with the investigational device
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Supraventricular Tachycardia
Keywords
PSVT, PFA, AVNRT, AVRT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective, single-center, single-group
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-randomized
Arm Type
Experimental
Arm 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
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
Immediate 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 immediate 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 2-Month Post-Procedure
Description
Refers to the postoperative phase after 2 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 2 months postoperatively
Title
Evaluation of Force Sensing Pulsed Field Ablation Catheter
Description
Evaluation of catheter operation performance;Catheter ablation parameters
Time Frame
1 Day of surgery
Title
Evaluation of Pulse Ablation equipment
Description
System software operability; System operation stability; Hardware connection validity
Time Frame
immediately post ablation
Other Pre-specified Outcome Measures:
Title
Security Endpoints
Description
Incidence of adverse events and serious adverse events associated with the study device
Time Frame
Within 2 months after sign the informed consent form
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with symptomatic paroxysmal supraventricular tachycardia including:Atrioventricular nodal re-entrant tachycardia, Atrioventricular arrhythmias;
Willingness to undergo an evaluation to validate the requirements of the protocol.
Voluntary signed informed consent and willingness to undergo the tests and procedures required by the protocol.
Exclusion Criteria:
Patients with intracardiac thrombosis at the time of study or with a history of thromboembolic event within past 3 months
History of any cardiac surgery
Presence of any implantation, such as artificial valves, permanent pacemakers, etc
Patients with active systemic infections
Any condition contraindicating septal puncture or retrograde transaortic approach for procedures
Any condition contraindicating heparin or indobufen
Patients with advanced malignant tumor
Any woman known to be pregnant or breastfeeding
8. Unwilling or unable to comply fully with study procedures and follow-up 9. Unable to provide own informed consent
Facility Information:
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）
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