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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-10

Study Completion Date

2024-02-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Patent Foramen Ovale PFO

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PFO subjects

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

The Cera™ PFO Occluder

Intervention Type DEVICE

The Cera™ PFO Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of Patent Foramen Ovale (PFO).

Interventions

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The Cera™ PFO Occluder

The Cera™ PFO Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of Patent Foramen Ovale (PFO).

Intervention Type DEVICE

Eligibility Criteria

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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.