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

Cardiac Imaging Techniques Clinical Trial

— EchoNav  

Official title:

Safety and Efficacy of EchoNavigator System Release II (Philips, Andover, MA) During Structural Heart Interventions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02608008
• Other study ID #: EchoNav
• Status: Active, not recruiting
• Start date: September 2014
• Est. completion date: June 2021

Study information

• Verified date: February 2021
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: June 2021
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Imaging Techniques

Intervention

Device:
• Data analysis
data parameters Analysis

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Dusseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of procedure time	During interventions with and without the use of EchoNavigator System Release II	baseline
Secondary	Comparison of area dose product	During procedures with and without the use of EchoNavigator System Release II	baseline
Secondary	Comparison of contrast agent amount	During procedures with and without the use of EchoNavigator System Release II	baseline
Secondary	Comparison of data measurements of fluoroscopy time	During procedures with and without the use of EchoNavigator System Release II	baseline
Secondary	Comparison of duration of the transeptal punction	During mitraClip implantations, ASD/PFO with and without the use of EchoNavigator System Release II.	baseline