Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-11

Study Completion Date

2023-07-13

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Paroxysmal Supraventricular Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective, single-center, single-group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-randomized

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

Group Type EXPERIMENTAL

Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter

Intervention Type DEVICE

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

Interventions

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Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter

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

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No