Lifetech CeraFlex™ Post-Market Surveillance Study
Study Details
Study Description
Brief 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) or Patent Ductus Arteriosus (PDA).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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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.
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Patients will be screened to confirm study eligibility with pre-defined inclusion/exclusion criteria prior to enrollment.
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: CeraFlex occluder The Lifetech CeraFlex™ study is a triple-arm study. |
Device: CeraFlex
The Lifetech CeraFlex™ study is a triple-arm study.
|
Outcome Measures
Primary Outcome Measures
- Procedural success [immediate post procedure]
Absence of peri-procedural stroke/TIA, device embolization, cardiac or vascular perforation or death;Successful deployment of the occluder device(s).
Eligibility Criteria
Criteria
Inclusion criteria
To participate in this study, the patient must meet all of the following inclusion criteria:
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Confirmed ASD, PFO or PDA and patient characteristics consistent with the corresponding IFU and sizing guidelines;
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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);
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The patient agrees to comply with requirements of the study including the 12 months followup.
Exclusion criteria
Patients will be excluded if any of the following conditions apply:
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Any contra-indication mentioned in the corresponding IFU;
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Currently participating in another investigational drug- or device study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AP Hospital Europeen G Pompidou and Hospital Necker | Paris | France | ||
| 2 | Deutsches Herzzentrum Berlin | Berlin | Germany | ||
| 3 | Herzzentrum Leipzig GmbH | Leipzig | Germany | ||
| 4 | Deutsches Herzzentrum München | Munich | Germany | ||
| 5 | Our Lady's Children's Hospital Crumlin | Dublin | Ireland | ||
| 6 | Policlinico San Donato S.P.A. | Milan | Italy | ||
| 7 | Kinderspital Zürich | Zürich | Switzerland |
Sponsors and Collaborators
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Medtronic
Investigators
- Principal Investigator: Kevin Walsh, Professor, Our Lady's Children's Hospital, Crumlin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CeraFlex™ PMSS