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

February 15, 2021 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dusseldorf, Germany, 40225
        • Division of Cardiology, Pulmonary Disease and Vascular Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult male or female patients undergoing structural heart interventions like transfemoral aortic valve Implantation (TAVI), MitraClip implantation, patent foramen ovale (PFO), atrial septal defect (ASD) and left atrial appendage (LAA) with or without the periintervention use of the EchoNavigator System Release II.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Data analysis transfemoral aortic valve implantation
Periinterventional data analysis during structural heart procedures like transfemoral aortic valve implantation with and without the use of EchoNavigator System Release II.
Device: Data analysis
data parameters Analysis
Data analysis MitraClip
Periinterventional data analysis during structural heart procedures like MitraClip Implantations with and without the use of EchoNavigator System Release II.
Device: Data analysis
data parameters Analysis
Data analysis PFO
Periinterventional data analysis during structural heart procedures like PFO implantations with and without the use of EchoNavigator System Release II.
Device: Data analysis
data parameters Analysis
Data analysis ASD
Periinterventional data analysis during structural heart procedures like ASD implantations with and without the use of EchoNavigator System Release II.
Device: Data analysis
data parameters Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of procedure time
Time Frame: baseline
During interventions with and without the use of EchoNavigator System Release II
baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 31, 2018

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EchoNav

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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