Lifetech CeraFlex™ Post-Market Surveillance Study

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Brief Title

Lifetech CeraFlex™ Post-Market Surveillance Study

Official Title

Multi-center, Prospective, Post-market Study

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 Type

Interventional


Primary Outcome

Procedural success


Condition

Patent Foramen Ovale

Intervention

CeraFlex

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

120

Start Date

October 2015

Completion Date

February 2020

Primary Completion Date

January 2019

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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Kevin Walsh, Professor, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02621528

Organization ID

CeraFlex™ PMSS


Responsible Party

Sponsor

Study Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Collaborators

 Medtronic

Study Sponsor

Kevin Walsh, Professor, Principal Investigator, Our Lady's Children's Hospital, Crumlin


Verification Date

March 2020