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Lifetech CeraFlex™ Post-Market Surveillance Study

NCT02621528 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-03-13

No results posted yet for this study

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).

Conditions

  • Patent Foramen Ovale
  • Atrial Septal Defect
  • Patent Ductus Arteriosus

Interventions

DEVICE

CeraFlex

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

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kevin Walsh, Professor · Our Lady's Children's Hospital, Crumlin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-01-31
Completion
2020-02-29

Countries

  • France
  • Germany
  • Ireland
  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02621528 on ClinicalTrials.gov