Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）

NCT05770921 | Completed

• 1 other identifier: 775035
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Supraventricular Tachycardia

Keywords

PSVT; PFA; AVNRT; AVRT

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Refers to the postoperative phase after 6 months postoperatively

Secondary Outcomes (4)

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

  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 postoperatively

• Evaluation of Force Sensing Pulsed Field Ablation Catheter

  1 Day of surgery

• Evaluation of Pulse Ablation equipment

  immediately post ablation

Other Outcomes (1)

• Security Endpoints

  Within 6 months after sign the informed consent form

Study Arms (1)

Non-randomized

EXPERIMENTAL

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

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

Interventions

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

Non-randomized

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

Ningbo First Hospital

Ningbo, Zhejiang, China

Location

Related Publications (1)

• Shen C, Du X, Dai J, Feng M, Yu Y, Liu J, Fu G, Wang B, Jiang Y, Jin H, Chu H. Outcomes of Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia. Can J Cardiol. 2024 Jul;40(7):1294-1303. doi: 10.1016/j.cjca.2023.12.037. Epub 2024 Jan 17.

  PMID: 38242530 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: prospective, single-center, single-group

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 16, 2023
• Study Start: October 11, 2022
• Primary Completion: February 1, 2023
• Study Completion: July 13, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)