NCT02621528

Lifetech CeraFlex™ Post-Market Surveillance Study

Multi-center, Prospective, Post-market Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	CeraFlex	The Lifetech CeraFlex™ study is a triple-arm study.

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-01-01
• Completion: 2020-02-01
• First posted: 2015-12-03
• Last updated: 2020-03-13

Locations

7 sites across 5 countries: France, Germany, Ireland, Italy, Switzerland