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OpenTrials
Completed

NCT Number: NCT05893758

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

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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Key information

Conditions

Patent Foramen Ovale Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial PFO

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

The Cera™ PFO Occluder

Device

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

Primary outcomes

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

    Time frame: from attempted procedure to 24 months post-implantation.

    Serious procedure/device complications include device embolization, cardiac or vascular perforation, atrial fibrillation, device thrombosis, pulmonary embolism and deep vein thrombosis.

Secondary outcomes

  1. Successful closure of the PFO, confirmed by contrast Transcranial Doppler (cTCD), defined as with no, small or moderate residual shunt

    Time frame: at procedure, 6 months and 12 months post-implantation

  2. Incidence of device or procedure related Adverse Events (AEs)

    Time frame: from attempted procedure to 24 months post-implantation

  3. Incidence of device or procedure related Serious Adverse Events (SAEs)

    Time frame: from attempted procedure to 24 months post-implantation

  4. Incidence of Device Deficiencies (DD)

    Time frame: from attempted procedure to 24 months post-implantation

  5. Incidence of death

    Time frame: from attempted procedure to 24 months post-implantation

Sponsors and collaborators

Lead sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2023
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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