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Clinical Trial Summary

The purpose of this study was to explore the safety and efficacy of a Pulsed Field Ablation(PFA) Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia(PSVT)


Clinical Trial Description

The primary endpoint of this sutdy is the actue ablation success rate for all subjects, other endpoints include treatment success rate within 6 months after surgery, evaluation of equipment and cather. The primary safety endpoint for this study is the incidence of early-onset (within 7 days of the PFA ablation procedure) primary adverse events (AEs), ohter satety endpoints are incidence of AEs associated with the study devices and serious adverse events(SAEs). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05820035
Study type Interventional
Source Shanghai MicroPort EP MedTech Co., Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date March 9, 2023
Completion date December 31, 2024

See also
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Completed NCT05770921 - Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia(PSVT) N/A
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Recruiting NCT05410860 - Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia Phase 3
Completed NCT03464019 - Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxymal Supraventricular Tachycardia (PSVT). NODE 301 [Part 1 and Part 2 (RAPID Study)] Phase 3
Completed NCT03042078 - Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia N/A
Completed NCT04215640 - Radiofrequency Ablation of Paroxysmal Supraventricular Tachycardia Using a Novel Catheter Equipped With Mini Electrodes N/A
Completed NCT03348436 - Study on Left Atrial Function of Paroxysmal Supraventricular Tachycardia After Radiofrequency Ablation N/A
Enrolling by invitation NCT04952610 - Etripamil Nasal Spray in Patients With Paroxysmal Supraventricular Tachycardia Phase 3
Recruiting NCT05763953 - The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients) Phase 2
Terminated NCT03635996 - Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302 Phase 3