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Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up | Clinical Trials | Clareo Health

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

A Real-world Registry Assessing the Clinical Use of the Lifetech Cera™ PFO Occluder

NCT05893758•Lifetech Scientific (Shenzhen) Co., Ltd.

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.

Eligibility

Age

All ages

Sex

ALL

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.

Locations (5)

Oddział Kardiologii, Pracownia Hemodynamiki, Oddział Intensywnego Nadzoru Kardiologicznego oraz Pracownia Elektrofizjologii w Szpitalu w Myszkowie G.V.M.Carint

Myszków, Poland

Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii G.V.M.Carint-Oświęcim

Oświęcim, Poland

Polsko-Amerykańskie Kliniki Serca, Centrum Sercowo- Naczyniowe w Tychach, Grupa American Heart of Poland

Tychy, Poland

Polsko-Amerykańskie Kliniki Serca I Oddział Kardiologii Inwazyjnej i Niewydolności Serca w Ustroniu, Grupa AHoP

Ustroń, Poland

Szpital Powiatowy im. dr Tytusa Chałubińskiego w Zakopanem

Zakopane, Poland

Key Dates

Start Date

August 10, 2023

Primary Completion Date

February 1, 2024

Completion Date

February 1, 2024

Last Updated

August 30, 2024

Enrollment

ACTUAL participants

Conditions

Patent Foramen OvalePFO

Interventions

The Cera™ PFO Occluder

DEVICE

Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study

NCT07172464

PFOPFO - Patent Foramen Ovale+3 more

View study

RECRUITING

Non-Invasive Detection of Right-to-Left Cardiac Shunts

NCT07420400

Patent Foramen Ovale (PFO)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study

Non-Invasive Detection of Right-to-Left Cardiac Shunts

Abbott Structural Heart Device Registry

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

Cerebral Microembolization Associated With PFO Closure

Russian Registry of Endovascular Closure of PFO