Patent Foramen OvaleNCT05893758
Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up
An observational study of Patent Foramen Ovale and PFO, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 5 sites in Poland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patent Foramen Ovale, PFO
- What is being tested?
- The Cera™ PFO Occluder
- Type of treatment
- Medical device
- How many people
- 94 participants
- Where
- 5 sitesPoland
- Study dates
- 10 Aug 2023to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Any contraindication mentioned in the corresponding IFU;
- Patients did not conduct any follow up visit after hospital discharge.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites
Oddział Kardiologii, Pracownia Hemodynamiki, Oddział Intensywnego Nadzoru Kardiologicznego oraz Pracownia Elektrofizjologii w Szpitalu w Myszkowie G.V.M.Carint
Myszków
Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii G.V.M.Carint-Oświęcim
Oświęcim
Polsko-Amerykańskie Kliniki Serca, Centrum Sercowo- Naczyniowe w Tychach, Grupa American Heart of Poland
Tychy
Polsko-Amerykańskie Kliniki Serca I Oddział Kardiologii Inwazyjnej i Niewydolności Serca w Ustroniu, Grupa AHoP
Ustroń
Szpital Powiatowy im. dr Tytusa Chałubińskiego w Zakopanem
Zakopane
About this study
Official title: 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.
- Conditions
- Patent Foramen Ovale, PFO
- Being tested
- The Cera™ PFO Occluder
- Keywords
- Lifetech, Cera PFO, Occluder
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Cera™ PFO OccluderDevice
The Cera™ PFO Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of Patent Foramen Ovale (PFO).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: The Cera™ PFO Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: at procedure, 6 months and 12 months post-implantation
Incidence of device or procedure related Adverse Events (AEs)
Measured: from attempted procedure to 24 months post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)
Measured: from attempted procedure to 24 months post-implantation
Incidence of Device Deficiencies (DD)
Measured: from attempted procedure to 24 months post-implantation
Incidence of death
Measured: from attempted procedure to 24 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start10 Aug 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893758
- Sponsor's protocol ID
- LT-TS-275-2023-02
- Status last verified
- Aug 2024
- First submitted
- 30 May 2023
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Registry Assessing the Clinical Use of the Lifetech Cera™ PFO Occluder
- ClinicalTrials.gov ID
- NCT05893758
- Acronym / sponsor ID
- LT-TS-275-2023-02
- Conditions
- Patent Foramen Ovale, PFO
- Keywords
- Lifetech, Cera PFO, Occluder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PFO subjects | – | Device: The Cera™ PFO OccluderPatients with a confirmed diagnosis of Patent Foramen Ovale (PFO) which is associated with TIA or cryptogenic stroke, and implanted with the investigational device. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Any contraindication mentioned in the corresponding IFU;
- Patients did not conduct any follow up visit after hospital discharge.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Cera™ PFO OccluderThe Cera™ PFO Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of Patent Foramen Ovale (PFO). | Device | PFO subjects |
Primary outcome
Incidence of stroke/TIA, procedure/device-related death and serious procedure/device complications
Time frame: 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.
5 secondary outcomes
Successful closure of the PFO, confirmed by contrast Transcranial Doppler (cTCD), defined as with no, small or moderate residual shunt
Time frame: at procedure, 6 months and 12 months post-implantation
Incidence of device or procedure related Adverse Events (AEs)
Time frame: from attempted procedure to 24 months post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)
Time frame: from attempted procedure to 24 months post-implantation
Incidence of Device Deficiencies (DD)
Time frame: from attempted procedure to 24 months post-implantation
Incidence of death
Time frame: from attempted procedure to 24 months post-implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Foramen Ovale and PFO, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 5 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of stroke/TIA, procedure/device-related death and serious procedure/device complications (time frame: from attempted procedure to 24 months post-implantation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.