Clinical trial NCT02621528: Lifetech CeraFlex™ Post-Market Surveillance Study
Official title: Multi-center, Prospective, Post-market Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patent Foramen Ovale
Atrial Septal Defect
Patent Ductus Arteriosus
Keywords: CeraFlex occluder
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2015-12-03
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion criteria

To participate in this study, the patient must meet all of the following inclusion criteria:

1. Confirmed ASD, PFO or PDA and patient characteristics consistent with the corresponding IFU and sizing guidelines;
2. 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);
3. 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:

1. Any contra-indication mentioned in the corresponding IFU;
2. Currently participating in another investigational drug- or device study.

Primary outcomes:
measure: Procedural success
timeFrame: immediate post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: AP Hospital Europeen G Pompidou and Hospital Necker
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
city: Dublin
country: Ireland
facility: Our Lady's Children's Hospital Crumlin
city: Milan
country: Italy
facility: Policlinico San Donato S.P.A.
city: Zürich
country: Switzerland
facility: Kinderspital Zürich
Study officials:
affiliation: Our Lady's Children's Hospital, Crumlin
name: Kevin Walsh, Professor
role: PRINCIPAL_INVESTIGATOR
References: