Lifetech CeraFlex™ Post-Market Surveillance Study

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).

Study Overview

• Status: Completed
• Conditions: Atrial Septal Defect; Patent Foramen Ovale; Patent Ductus Arteriosus
• Intervention / Treatment: Device: CeraFlex

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
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France
    • AP Hospital Europeen G Pompidou and Hospital Necker
• Germany
  • Berlin, Germany
    • Deutsches Herzzentrum Berlin
  • Leipzig, Germany
    • Herzzentrum Leipzig GmbH
  • Munich, Germany
    • Deutsches Herzzentrum München
• Ireland
  • Dublin, Ireland
    • Our Lady's Children's Hospital Crumlin
• Italy
  • Milan, Italy
    • Policlinico San Donato S.P.A.
• Switzerland
  • Zürich, Switzerland
    • Kinderspital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Absence of peri-procedural stroke/TIA, device embolization, cardiac or vascular perforation or death;Successful deployment of the occluder device(s).	immediate post procedure

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
• Collaborators: Medtronic
• Investigators: Principal Investigator: Kevin Walsh, Professor, Our Lady's Children's Hospital, Crumlin

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Actual): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: CeraFlex occluder
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Heart Septal Defects, Atrial; Foramen Ovale, Patent; Ductus Arteriosus, Patent
• Other Study ID Numbers: CeraFlex™ PMSS