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Completed

NCT Number: NCT05770921

Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）

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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Key information

Conditions

Paroxysmal Supraventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ningbo First Hospital

Ningbo, Zhejiang, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 structural heart disease
  • History of any cardiac surgery
  • Failure of prior ablation of PSVT
  • 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 aspirin
  • Patients with advanced malignant tumor
  • Any woman known to be pregnant or breastfeeding
  • Unwilling or unable to comply fully with study procedures and follow-up
  • Unable to provide own informed consent
  • Coexistence with other arrhythmias

Treatment and study plan

Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter

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

Primary outcomes

  1. Immediate ablation success rate

    Time frame: 15 minutes post ablation

    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

  2. Rate of Treatment Success at 6-Month Post-Procedure

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

    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.

Secondary outcomes

  1. Rate of Treatment Success at 1-Month Post-Procedure

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

    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.

  2. Rate of Treatment Success at 2-Month Post-Procedure

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

    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.

  3. Evaluation of Force Sensing Pulsed Field Ablation Catheter

    Time frame: 1 Day of surgery

    Evaluation of catheter operation performance;Catheter ablation parameters

  4. Evaluation of Pulse Ablation equipment

    Time frame: immediately post ablation

    System software operability; System operation stability; Hardware connection validity

Other outcomes

  1. Security Endpoints

    Time frame: Within 6 months after sign the informed consent form

    Incidence of adverse events and serious adverse events associated with the study device

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Official study 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）

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2023
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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