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

August 29, 2024 updated by: Lifetech Scientific (Shenzhen) Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Myszków, Poland
        • Oddział Kardiologii, Pracownia Hemodynamiki, Oddział Intensywnego Nadzoru Kardiologicznego oraz Pracownia Elektrofizjologii w Szpitalu w Myszkowie G.V.M.Carint
      • Oświęcim, Poland
        • Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii G.V.M.Carint-Oświęcim
      • Tychy, Poland
        • Polsko-Amerykańskie Kliniki Serca, Centrum Sercowo- Naczyniowe w Tychach, Grupa American Heart of Poland
      • Ustroń, Poland
        • Polsko-Amerykańskie Kliniki Serca I Oddział Kardiologii Inwazyjnej i Niewydolności Serca w Ustroniu, Grupa AHoP
      • Zakopane, Poland
        • Szpital Powiatowy im. dr Tytusa Chałubińskiego w Zakopanem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
The Cera™ PFO Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of Patent Foramen Ovale (PFO).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
from attempted procedure to 24 months post-implantation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
from attempted procedure to 24 months post-implantation
Incidence of Device Deficiencies (DD)
Time Frame: from attempted procedure to 24 months post-implantation
from attempted procedure to 24 months post-implantation
Incidence of death
Time Frame: from attempted procedure to 24 months post-implantation
from attempted procedure to 24 months post-implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lifetech Scientific (Shenzhen) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LT-TS-275-2023-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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