Safety and Efficacy of EchoNavigator System Release II During Structural Heart Interventions

• Conditions: Cardiac Imaging Techniques

• Registration Number: NCT02608008
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief Summary

The purpose of this study is to collect data regarding the safety and efficacy of EchoNavigator System Release II during structural heart interventions in the clinical practice. Data of procedures with and without the use of EchoNavigator System Release II will be collected, analysed and evaluated.

Detailed Description

EchoNavigator System Release II is a CE certified innovative periinterventional imaging modality used in our clinic of cardiology, pulmonology and angiology during structural heart interventions like transfemoral aortic valve Implantation (TAVI), MitraClip implantation, patent foramen ovale (PFO), atrial septal defect (ASD) and left atrial appendage (LAA). During this interventions EchoNavigator is able to combine live X-ray Images and 3D Echo guidance to enhance the efficiency of the procedure.

Specific periprocedural data parameter, e.g. procedure duration, radiation time, radiation dose, transseptal punction time (e.g.LAA) and contrast agent amount will be collected and analysed. The same data characteristics from the same procedures but without the periinterventional use of the EchoNavigator System Release II will be collected, analysed and compared with the data described above. A retrospective data collection between 2013 - 2017 of n=500 patients will be conducted.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Primary Completion: 2018-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-16
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Adult male or female patients of any ethnic origin aged > 18 years
• Signed and dated informed consent for the prospective study part

Exclusion Criteria

• < 18 year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of procedure time	baseline	During interventions with and without the use of EchoNavigator System Release II

Secondary Outcome Measures

Name	Time	Method
Comparison of data measurements of fluoroscopy time	baseline	During procedures with and without the use of EchoNavigator System Release II
Comparison of area dose product	baseline	During procedures with and without the use of EchoNavigator System Release II
Comparison of contrast agent amount	baseline	During procedures with and without the use of EchoNavigator System Release II
Comparison of duration of the transeptal punction	baseline	During mitraClip implantations, ASD/PFO with and without the use of EchoNavigator System Release II.

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Dusseldorf, Germany