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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608008
Recruitment Status : Active, not recruiting
First Posted : November 18, 2015
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, 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.

Condition or disease Intervention/treatment
Cardiac Imaging Techniques Device: Data analysis

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Safety and Efficacy of EchoNavigator System Release II (Philips, Andover, MA) During Structural Heart Interventions
Study Start Date : September 2014
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 2020

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




Primary Outcome Measures :
  1. Comparison of procedure time [ Time Frame: baseline ]
    During interventions with and without the use of EchoNavigator System Release II


Secondary Outcome Measures :
  1. Comparison of area dose product [ Time Frame: baseline ]
    During procedures with and without the use of EchoNavigator System Release II

  2. Comparison of contrast agent amount [ Time Frame: baseline ]
    During procedures with and without the use of EchoNavigator System Release II

  3. Comparison of data measurements of fluoroscopy time [ Time Frame: baseline ]
    During procedures with and without the use of EchoNavigator System Release II

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608008


Locations
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Germany
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Dusseldorf, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
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Study Chair: Malte Kelm, MD Division of Cardiology, Pulmonary Disease and Vascular Medicine

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Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, PD Dr. med. Tobias Zeus, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02608008    
Other Study ID Numbers: EchoNav
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
3D-Ultrasound
Live X-rays
EchoNavigator System