Lifetech CeraFlex™ Post-Market Surveillance Study
|Conditions||patent foramen ovale, atrial septal defect, patent ductus arteriosus|
|Sponsor||Lifetech Scientific (Shenzhen) Co., Ltd.|
|Start date||October 2015|
|End date||June 2017|
|Trial size||120 participants|
|Trial identifier||NCT02621528, CeraFlex™ PMSS|
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).
|Intervention model||single group assignment|
The Lifetech CeraFlex™ study is a triple-arm study.
time frame: immediate post procedure
All participants of any age.
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 provided written informed consent, approved by the appropriate Ethics Committee (EC); 3. The patient agrees to comply with requirements of the study including the 12 months follow-up. 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 an investigational drug- or device study.
|Official title||Multi-center, Prospective, Post-market Study|
|Principal investigator||Andreas Eicken, Dr.|
|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.|
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