Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）

Ningbo No. 1 Hospital10 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Paroxysmal Supraventricular Tachycardia

Interventions

Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation CatheterDEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with symptomatic paroxysmal supraventricular tachycardia including:Atrioventricular nodal re-entrant tachycardia, Atrioventricular arrhythmias; 2. Willingness to undergo an evaluation to validate the requirements of the protocol. 3. Voluntary signed informed consent and willingness to undergo the tests and procedures required by the protocol. Exclusion Criteria: 1. Patients with structural heart disease 2. History of any cardiac surgery 3. Failure of prior ablation of PSVT 4. Presence of any implantation, such as artificial valves, permanent pacemakers, etc 5. Patients with active systemic infections 6. Any condition contraindicating septal puncture or retrograde transaortic approach for procedures 7. Any condition contraindicating heparin or aspirin 8. Patients with advanced malignant tumor 9. Any woman known to be pregnant or breastfeeding 10. Unwilling or unable to comply fully with study procedures and follow-up 11. Unable to provide own informed consent 12. Coexistence with other arrhythmias

Locations (1)

Ningbo First Hospital

Ningbo, Zhejiang, China

Outcomes

Primary Outcomes

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

Time frame: 15 minutes post ablation

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.

Time frame: Refers to the postoperative phase after 6 months postoperatively

Secondary Outcomes

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.

Time frame: Refers to the postoperative phase after 1 months postoperatively

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.

Time frame: Refers to the postoperative phase after 2 months postoperatively

Evaluation of Force Sensing Pulsed Field Ablation Catheter

Evaluation of catheter operation performance;Catheter ablation parameters

Time frame: 1 Day of surgery

Data from ClinicalTrials.gov

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