Lifetech CeraFlex™ Post-Market Surveillance Study

Not Applicable

Completed

• Conditions: Atrial Septal Defect; Patent Foramen Ovale; Patent Ductus Arteriosus
• Interventions: Device: CeraFlex

• Registration Number: NCT02621528
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-03
• Primary Completion: 2019-01
• Study Completion: 2020-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CeraFlex occluder	CeraFlex	The Lifetech CeraFlex™ study is a triple-arm study.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (7)

Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, Germany

Deutsches Herzzentrum München; 🇩🇪 Munich, Germany

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Kinderspital Zürich; 🇨🇭 Zürich, Switzerland

Our Lady's Children's Hospital Crumlin; 🇮🇪 Dublin, Ireland

Policlinico San Donato S.P.A.; 🇮🇹 Milan, Italy

AP Hospital Europeen G Pompidou and Hospital Necker; 🇫🇷 Paris, France