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

Patent Foramen Ovale Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893758
• Other study ID #: LT-TS-275-2023-02
• Status: Recruiting
• Start date: August 22, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: Rae Gong
• Phone: (86-755)-86026250-6957
• Email: gongrui[@]lifetechmed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Patent Foramen Ovale
• PFO

Intervention

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).

Locations

Country	Name	City	State
Poland	Szpital Miejski Nr 4 w Gliwicach	Gliwice
Poland	Oddzial Kardiologii, Pracownia Hemodynamiki, Oddzial 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-Oswiecim	Oswiecim
Poland	Podkarpackie Centrum Interwencji Sercowo- naczyniowej G.V.M.Carint -Sanok	Sanok
Poland	Polsko-Amerykanskie Kliniki Serca, Centrum Sercowo- Naczyniowe w Tychach, Grupa American Heart of Poland	Tychy
Poland	Polsko-Amerykanskie Kliniki Serca I Oddzial Kardiologii Inwazyjnej i Niewydolnosci Serca w Ustroniu, Grupa AHoP	Ustron
Poland	Szpital Powiatowy im. dr Tytusa Chalubinskiego w Zakopanem	Zakopane

Sponsors (1)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Incidence of device or procedure related Adverse Events (AEs)		from attempted procedure to 24 months post-implantation
Secondary	Incidence of device or procedure related Serious Adverse Events (SAEs)		from attempted procedure to 24 months post-implantation
Secondary	Incidence of Device Deficiencies (DD)		from attempted procedure to 24 months post-implantation
Secondary	Incidence of death		from attempted procedure to 24 months post-implantation