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

Completed

• Conditions: Patent Foramen Ovale; PFO
• Interventions: Device: The Cera™ PFO Occluder

• Registration Number: NCT05893758
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-06-08
• Study Start: 2023-08-22
• Primary Completion: 2024-02-05
• Study Completion: 2024-02-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PFO subjects	The Cera™ PFO Occluder	Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO) which is associated with TIA or cryptogenic stroke, and implanted with the investigational device.

Primary Outcome Measures

Name	Time	Method
Incidence of stroke/TIA, procedure/device-related death and serious procedure/device complications	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 Outcome Measures

Name	Time	Method
Incidence of device or procedure related Adverse Events (AEs)	from attempted procedure to 24 months post-implantation
Incidence of death	from attempted procedure to 24 months post-implantation
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 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

Trial Locations

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 I Oddział Kardiologii Inwazyjnej i Niewydolności Serca w Ustroniu, Grupa AHoP; 🇵🇱 Ustroń, Poland

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

Szpital Powiatowy im. dr Tytusa Chałubińskiego w Zakopanem; 🇵🇱 Zakopane, Poland