NCT02608008

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

4.3 years

First QC Date

November 16, 2015

Last Update Submit

February 15, 2021

Conditions

Cardiac Imaging Techniques

Keywords

3D-UltrasoundLive X-raysEchoNavigator System

Outcome Measures

Primary Outcomes (1)

  • Comparison of procedure time

    During interventions with and without the use of EchoNavigator System Release II

    baseline

Secondary Outcomes (4)

  • Comparison of area dose product

    baseline

  • Comparison of contrast agent amount

    baseline

  • Comparison of data measurements of fluoroscopy time

    baseline

  • Comparison of duration of the transeptal punction

    baseline

Study Arms (4)

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 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 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 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

Interventions

Data analysisDEVICE

data parameters Analysis

Data analysis ASDData analysis MitraClipData analysis PFOData analysis transfemoral aortic valve implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • \< 18 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Location

Study Officials

  • Malte Kelm, MD

    Division of Cardiology, Pulmonary Disease and Vascular Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. Tobias Zeus

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 18, 2015

Study Start

September 1, 2014

Primary Completion

December 31, 2018

Study Completion

June 1, 2021

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

DE(1)