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

NCT05893758 | Completed

• 1 other identifier: LT-TS-275-2023-02
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 5

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.

Conditions

Patent Foramen Ovale; PFO

Keywords

Lifetech; Cera PFO; Occluder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

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

Interventions

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).

PFO subjects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (5)

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

Myszków, Poland

Location

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

Oświęcim, Poland

Location

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

Tychy, Poland

Location

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

Ustroń, Poland

Location

Szpital Powiatowy im. dr Tytusa Chałubińskiego w Zakopanem

Zakopane, Poland

Location

MeSH Terms

Conditions

Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: August 10, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5)