CompletedNot Applicable

Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up

Poland94 participantsStarted 2023-08-10

Plain-language summary

The objective of this post-market registry is to assess the clinical use of the Lifetech Cera™ PFO Occluder in a real-world and on-label fashion.

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO);
✓. Associated with TIA or cryptogenic stroke;
✓. Patients was implanted with the investigational device as per IFU instructions;
✓. Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.

Incidence of stroke/TIA, procedure/device-related death and serious procedure/device complications

Timeframe: from attempted procedure to 24 months post-implantation.

NCT IDNCT05893758

SponsorLifetech Scientific (Shenzhen) Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-02-01