NCT02621528

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
5 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

3.3 years

First QC Date

October 22, 2015

Last Update Submit

March 11, 2020

Conditions

Patent Foramen OvaleAtrial Septal DefectPatent Ductus Arteriosus

Keywords

CeraFlex occluder

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

CeraFlex occluder

OTHER

The Lifetech CeraFlex™ study is a triple-arm study.

Device: CeraFlex

Interventions

CeraFlexDEVICE

The Lifetech CeraFlex™ study is a triple-arm study.

CeraFlex occluder

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed ASD, PFO or PDA and patient characteristics consistent with the corresponding IFU and sizing guidelines;
  • 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);
  • The patient agrees to comply with requirements of the study including the 12 months followup.

You may not qualify if:

  • Patients will be excluded if any of the following conditions apply:
  • Any contra-indication mentioned in the corresponding IFU;
  • Currently participating in another investigational drug- or device study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

AP Hospital Europeen G Pompidou and Hospital Necker

Paris, France

Location

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

Deutsches Herzzentrum München

Munich, Germany

Location

Our Lady's Children's Hospital Crumlin

Dublin, Ireland

Location

Policlinico San Donato S.P.A.

Milan, Italy

Location

Kinderspital Zürich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Foramen Ovale, PatentHeart Septal Defects, AtrialDuctus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Kevin Walsh, Professor

    Our Lady's Children's Hospital, Crumlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2015

First Posted

December 3, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2019

Study Completion

February 1, 2020

Last Updated

March 13, 2020

Record last verified: 2020-03

Locations

FR(1)DE(3)IT(1)IE(1)CH(1)