PulseMagic™ TrueForce™ PAF NMPA Study

Sponsor
Shanghai MicroPort EP MedTech Co., Ltd.
Study ID
NCT07720557
Status
Not Yet Recruiting

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Conditions

  • Atrial Arrhythmia
  • Atrial Fibrillation (AF)
  • Drug Refractory Paroxysmal Atrial Fibrillation
  • Paroxysmal AF

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PFA Ablation catheter — DEVICE
    Deliver PF energy using the PulseMagic™ PFA system

Study Details

This clinical investigation is intended to demonstrate safety and effectiveness of the PulseMagic™ TrueForce™ Ablation Catheter and the PulseMagic™Pulse Field Ablation (PFA) Generator, and Columbus™ 3D EP Navigation System with Pulsed Field Ablation Software for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).

Key Dates

First listed
Jul 22, 2026
Start date
Jul 10, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PulseMagic™ TrueForce™ Ablation catheter
    A single use catheter that is designed to facilitate electrophysiological mapping of the heart chambers and PFA therapy to the catheter's flexible tip electrode for intracardiac ablation purposes.

Primary Outcome Measure

The success rate within 12 months after operation treatment without AADs [ Time Frame: 12 months ]

Central Contacts

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