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

Heinrich-Heine University, Duesseldorf

Status: Unknown

Conditions: Cardiac Imaging Techniques

Treatments: Device: Data analysis

Study type: Observational

Funder types: Other

Identifiers

NCT02608008

EchoNav

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 4 patient groups

Data analysis transfemoral aortic valve implantation

Description:

Periinterventional data analysis during structural heart procedures like transfemoral aortic valve implantation with and without the use of EchoNavigator System Release II.

Treatment:

Device: Data analysis

Data analysis MitraClip

Description:

Periinterventional data analysis during structural heart procedures like MitraClip Implantations with and without the use of EchoNavigator System Release II.

Treatment:

Device: Data analysis

Data analysis PFO

Description:

Periinterventional data analysis during structural heart procedures like PFO implantations with and without the use of EchoNavigator System Release II.

Treatment:

Device: Data analysis

Data analysis ASD

Description:

Periinterventional data analysis during structural heart procedures like ASD implantations with and without the use of EchoNavigator System Release II.

Treatment:

Device: Data analysis