Paroxysmal Supraventricular Tachycardia
Conditions
Keywords
PSVT, PFA, AVNRT, AVRT
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
Interventions
DEVICEPulsed 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
Sponsors
Ningbo No. 1 Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, single-center, single-group
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Treatment Success at 6-Month Post-Procedure | 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. |
| Immediate ablation success rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Treatment Success at 2-Month Post-Procedure | 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. |
| Evaluation of Pulse Ablation equipment | immediately post ablation | System software operability; System operation stability; Hardware connection validity |
| Evaluation of Force Sensing Pulsed Field Ablation Catheter | 1 Day of surgery | Evaluation of catheter operation performance;Catheter ablation parameters |
| Rate of Treatment Success at 1-Month Post-Procedure | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Security Endpoints | Within 6 months after sign the informed consent form | Incidence of adverse events and serious adverse events associated with the study device |
Countries
China
Outcome results
None listed