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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05893758
Other study ID # LT-TS-275-2023-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Terminated NCT01773252 - Right to Left Cardiac Shunt Detection Phase 3
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Completed NCT03377465 - Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis N/A
Active, not recruiting NCT04738071 - International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
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