Patent Foramen OvaleNCT02621528
Lifetech CeraFlex™ Post-Market Surveillance Study
A study testing CeraFlex in people with Patent Foramen Ovale and Atrial Septal Defect, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 7 sites in 5 countries.
Trial summary
The purpose of this multi-center, non-interventional, prospective, post-market clinical study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the Lifetech CeraFlex™ occluders for patients with secundum type Atrial Septum Defect (ASD), Patent Foramen Ovale (PFO)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patent Foramen Ovale, Atrial Septal Defect, Patent Ductus Arteriosus
- What is being tested?
- CeraFlex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Oct 2015to Feb 2020
- Phase
- Interventional
- 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
Who may be able to join
- To participate in this study, the patient must meet all of the following inclusion criteria:
- Confirmed ASD, PFO or PDA and patient characteristics consistent with the corresponding IFU and sizing guidelines;
- The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has signed the applicable Consent Form, approved by the appropriate Ethics Committee (EC)/IRB (where required);
- The patient agrees to comply with requirements of the study including the 12 months followup.
Who cannot join
- Patients will be excluded if any of the following conditions apply:
- Any contra-indication mentioned in the corresponding IFU;
- Currently participating in another investigational drug- or device study.
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Germany3 sites
Deutsches Herzzentrum Berlin
Berlin
Herzzentrum Leipzig GmbH
Leipzig
Deutsches Herzzentrum München
Munich
About this study
Official title: Multi-center, Prospective, Post-market Study
The purpose of this multi-center, non-interventional, prospective, post-market clinical study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the Lifetech CeraFlex™ occluders for patients with secundum type Atrial Septum Defect (ASD), Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA).
Read the detailed description
This study is designed as a post-market, prospective, multi-center, non-interventional clinical study to collect data regarding procedural success, clinical performance and cost-effectiveness of the Lifetech CeraFlex™ occluders in patients with secundum ASD, PFO and PDA.
Patients will be recruited in up to 12 investigational centers located in Europe and the Middle East.
To avoid bias in the study population the following measures will be taken:
- All sponsor or designee and external study personnel will be trained on the latest version of the Clinical Investigation Plan (CIP) and related study materials.
- Patients will be screened to confirm study eligibility with pre-defined inclusion/exclusion criteria prior to enrollment.
- This study will follow consecutive screening and enrollment.
The study will enroll 120 patients. The patient population will consist of up to approximately 40 consecutive enrolled patients with a confirmed secundum type ASD, up to approximately 40 enrolled patients with PFO and up to approximately 40 enrolled patients with PDA resulting in a significant shunt and in need of an intervention. These estimated upper limits per therapy group can however be exceeded depending on the enrollment trend, to account for a minimum of 10 patients to be enrolled per therapy group and a total study population of 120 enrolled patients.
- Being tested
- CeraFlex
- Keywords
- CeraFlex occluder
- Medical subject headings
- Foramen Ovale, Patent, Heart Septal Defects, Atrial, Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraFlexDevice
The Lifetech CeraFlex™ study is a triple-arm study.
| Study group | Role | What they receive |
|---|---|---|
| CeraFlex occluder | Other | The Lifetech CeraFlex™ study is a triple-arm study. Receives: Device: CeraFlex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Absence of peri-procedural stroke/TIA, device embolization, cardiac or vascular perforation or death;Successful deployment of the occluder device(s).
Measured: immediate post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2019
- Study completionFeb 2020
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Kevin Walsh, Professor, Principal investigator, Our Lady's Children's Hospital, Crumlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621528
- Sponsor's protocol ID
- CeraFlex™ PMSS
- Status last verified
- Mar 2020
- First submitted
- 22 Oct 2015
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Post-market Study
- ClinicalTrials.gov ID
- NCT02621528
- Acronym / sponsor ID
- CeraFlex™ PMSS
- Keywords
- CeraFlex occluder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Oct 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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 purpose of this multi-center, non-interventional, prospective, post-market clinical study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the Lifetech CeraFlex™ occluders for patients with secundum type Atrial Septum Defect (ASD), Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA).
Detailed description
This study is designed as a post-market, prospective, multi-center, non-interventional clinical study to collect data regarding procedural success, clinical performance and cost-effectiveness of the Lifetech CeraFlex™ occluders in patients with secundum ASD, PFO and PDA.
Patients will be recruited in up to 12 investigational centers located in Europe and the Middle East.
To avoid bias in the study population the following measures will be taken:
- All sponsor or designee and external study personnel will be trained on the latest version of the Clinical Investigation Plan (CIP) and related study materials.
- Patients will be screened to confirm study eligibility with pre-defined inclusion/exclusion criteria prior to enrollment.
- This study will follow consecutive screening and enrollment.
The study will enroll 120 patients. The patient population will consist of up to approximately 40 consecutive enrolled patients with a confirmed secundum type ASD, up to approximately 40 enrolled patients with PFO and up to approximately 40 enrolled patients with PDA resulting in a significant shunt and in need of an intervention. These estimated upper limits per therapy group can however be exceeded depending on the enrollment trend, to account for a minimum of 10 patients to be enrolled per therapy group and a total study population of 120 enrolled patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CeraFlex occluder | Other | Device: CeraFlexThe Lifetech CeraFlex™ study is a triple-arm study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- To participate in this study, the patient must meet all of the following inclusion criteria:
- Confirmed ASD, PFO or PDA and patient characteristics consistent with the corresponding IFU and sizing guidelines;
- The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has signed the applicable Consent Form, approved by the appropriate Ethics Committee (EC)/IRB (where required);
- The patient agrees to comply with requirements of the study including the 12 months followup.
Key exclusion criteria (3 listed)
- Any contra-indication mentioned in the corresponding IFU;
- Currently participating in another investigational drug- or device study.
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 |
|---|---|---|
| CeraFlexThe Lifetech CeraFlex™ study is a triple-arm study. | Device | CeraFlex occluder |
Primary outcome
Procedural success
Time frame: immediate post procedure
Absence of peri-procedural stroke/TIA, device embolization, cardiac or vascular perforation or death;Successful deployment of the occluder device(s).
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 13 Mar 2020.
Related trials for Patent Foramen Ovale
Active, not recruiting
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Stroke, Patent Foramen Ovale
RecruitingPhase 3
Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy
Migraine Disease, Patent Foramen Ovale
Recruiting
Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA
Patent Foramen Ovale, Stroke
RecruitingObservational study
Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention
Transcatheter Mitral Valve Edge-to-Edge Repair System, Biodegradable Patent Foramen Ovale Closure Device
Active, not recruitingObservational study
International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Stroke, Patent Foramen Ovale
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.
Kevin Walsh, Professor principal investigator
Our Lady's Children's Hospital, Crumlin
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CeraFlex in people with Patent Foramen Ovale and Atrial Septal Defect, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 7 sites in 5 countries.
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 3 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 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, France, Ireland, Italy, Switzerland. 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?
Procedural success (time frame: immediate post procedure). 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 13 Mar 2020.