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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patent Foramen Ovale; PFO
• Intervention / Treatment: Device: The Cera™ PFO Occluder

Detailed Description

The study intends to collect data from patients who have implanted with the device between 2019 to 2022. It is estimated to start enrollment in Sep 2023 and complete by end of 2024. Final report shall be completed in 2025.

• Study Type: Observational
• Enrollment (Estimated): 94

Contacts and Locations

• Study Contact: Name: Rae Gong; Phone Number: (86-755)-86026250-6957; Email: gongrui@lifetechmed.com

Study Locations

• Poland
  • Gliwice, Poland
    • Not yet recruiting
    • Szpital Miejski Nr 4 w Gliwicach
    • Contact: Przemyslaw Weglarz
    • Contact: Ewa K Kuszewska
  • Myszków, Poland
    • Recruiting
    • Oddział Kardiologii, Pracownia Hemodynamiki, Oddział Intensywnego Nadzoru Kardiologicznego oraz Pracownia Elektrofizjologii w Szpitalu w Myszkowie G.V.M.Carint
    • Contact: Przemyslaw Weglarz
    • Contact: Ewa K Kuszewska
  • Oświęcim, Poland
    • Recruiting
    • Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii G.V.M.Carint-Oświęcim
    • Contact: Przemyslaw Weglarz
    • Contact: Ewa K Kuszewska
  • Sanok, Poland
    • Not yet recruiting
    • Podkarpackie Centrum Interwencji Sercowo- naczyniowej G.V.M.Carint -Sanok
    • Contact: Przemyslaw Weglarz
    • Contact: Ewa K Kuszewska
  • Tychy, Poland
    • Recruiting
    • Polsko-Amerykańskie Kliniki Serca, Centrum Sercowo- Naczyniowe w Tychach, Grupa American Heart of Poland
    • Contact: Przemyslaw Weglarz
    • Contact: Ewa K Kuszewska
  • Ustroń, Poland
    • Recruiting
    • Polsko-Amerykańskie Kliniki Serca I Oddział Kardiologii Inwazyjnej i Niewydolności Serca w Ustroniu, Grupa AHoP
    • Contact: Przemyslaw Weglarz
    • Contact: Ewa K Kuszewska
  • Zakopane, Poland
    • Recruiting
    • Szpital Powiatowy im. dr Tytusa Chałubińskiego w Zakopanem
    • Contact: Przemyslaw Weglarz
    • Contact: Ewa K Kuszewska

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: The Cera™ PFO Occluder; The Cera™ PFO Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of Patent Foramen Ovale (PFO).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of stroke/TIA, procedure/device-related death and serious procedure/device complications	Serious procedure/device complications include device embolization, cardiac or vascular perforation, atrial fibrillation, device thrombosis, pulmonary embolism and deep vein thrombosis.	from attempted procedure to 24 months post-implantation.

Secondary Outcome Measures

Outcome Measure	Time Frame
Successful closure of the PFO, confirmed by contrast Transcranial Doppler (cTCD), defined as with no, small or moderate residual shunt	at procedure, 6 months and 12 months post-implantation
Incidence of device or procedure related Adverse Events (AEs)	from attempted procedure to 24 months post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)	from attempted procedure to 24 months post-implantation
Incidence of Device Deficiencies (DD)	from attempted procedure to 24 months post-implantation
Incidence of death	from attempted procedure to 24 months post-implantation

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Occluder; Lifetech; Cera PFO
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Foramen Ovale, Patent
• Other Study ID Numbers: LT-TS-275-2023-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No