Last updated on March 2017

Lifetech CeraFlex Post-Market Surveillance Study

Brief description of study

The purpose of this multi-center, interventional, prospective, post-market 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 Study Description

The Lifetech CeraFlex devices are CE marked and shall be used in this study within its intended use as described in the approved corresponding Instructions For Use (IFU). Approximately 120 patients will be included in this study. The patient population will consist of 40 consecutive patients with a confirmed secundum type ASD, 40 patients with PFO and 40 patients with PDA resulting in a significant shunt requiring intervention. This study will be conducted in up to 12 investigational centers located in Europe and in the Middle East. Subjects will be followed for 12 months post-procedure, with follow-ups as per local hospital standard which is expected to be at discharge, between 1 and 3 months, 6 months and 12 months.

Clinical Study Identifier: NCT02621528

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Andreas Eicken, Dr.

Deutsches Herzzentrum M nchen
Munich, Germany
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