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

LifeTech Scientific

Status: Completed

Conditions: PFO; Patent Foramen Ovale

Treatments: Device: The Cera™ PFO Occluder

Study type: Observational

Funder types: Industry

Identifiers

NCT05893758

LT-TS-275-2023-02

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Any contraindication mentioned in the corresponding IFU;
2. Patients did not conduct any follow up visit after hospital discharge.

Trial design

94 participants in 1 patient group

PFO subjects

Description:

Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO) which is associated with TIA or cryptogenic stroke, and implanted with the investigational device.

Treatment:

Device: The Cera™ PFO Occluder