Clinical trial NCT05770921: 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
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Supraventricular Tachycardia
Keywords: PSVT
PFA
AVNRT
AVRT
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, single-center, single-group
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Immediate ablation success rate
timeFrame: 15 minutes post ablation
measure: Rate of Treatment Success at 6-Month Post-Procedure
timeFrame: Refers to the postoperative phase after 6 months postoperatively
Secondary outcomes:
measure: Rate of Treatment Success at 1-Month Post-Procedure
timeFrame: Refers to the postoperative phase after 1 months postoperatively
measure: Rate of Treatment Success at 2-Month Post-Procedure
timeFrame: Refers to the postoperative phase after 2 months postoperatively
measure: Evaluation of Force Sensing Pulsed Field Ablation Catheter
timeFrame: 1 Day of surgery
measure: Evaluation of Pulse Ablation equipment
timeFrame: immediately post ablation
Other outcomes:
measure: Security Endpoints
timeFrame: Within 6 months after sign the informed consent form
Locations:
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
Study officials:
References: