Lifetech CeraFlex™ Post-Market Surveillance Study

Patent Ductus Arteriosus Clinical Trial

Official title:

Multi-center, Prospective, Post-market Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621528
• Other study ID #: CeraFlex™ PMSS
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: February 2020

Study information

• Verified date: March 2020
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Septal Defect
• Ductus Arteriosus, Patent
• Foramen Ovale, Patent
• Heart Septal Defects, Atrial
• Patent Ductus Arteriosus
• Patent Foramen Ovale

Intervention

Device:
• CeraFlex
The Lifetech CeraFlex™ study is a triple-arm study.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.	Medtronic

Countries where clinical trial is conducted

France,  Germany,  Ireland,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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