Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）

Ningbo No. 1 Hospital

Status: Completed

Conditions: Paroxysmal Supraventricular Tachycardia

Treatments: Device: Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT05770921

775035

Details and patient eligibility

About

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.

Full 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

Enrollment: 10 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Non-randomized

Experimental group

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

Treatment:

Device: Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter