Cardiac Imaging TechniquesEchoNavNCT02608008
Safety and Efficacy of EchoNavigator System Release II During Structural Heart Interventions
An observational study of Cardiac Imaging Techniques, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Imaging Techniques
- What is being tested?
- Data analysis
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult male or female patients of any ethnic origin aged > 18 years
- Signed and dated informed consent for the prospective study part
Who cannot join
- < 18 year
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Imaging Techniques
- Being tested
- Data analysis
- Keywords
- 3D-Ultrasound, Live X-rays, EchoNavigator System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data analysisDevice
data parameters Analysis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Data analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of procedure time
During interventions with and without the use of EchoNavigator System Release II
Measured: baseline
Secondary outcomes (4)
Comparison of area dose product
During procedures with and without the use of EchoNavigator System Release II
Measured: baseline
Comparison of contrast agent amount
During procedures with and without the use of EchoNavigator System Release II
Measured: baseline
Comparison of data measurements of fluoroscopy time
During procedures with and without the use of EchoNavigator System Release II
Measured: baseline
Comparison of duration of the transeptal punction
During mitraClip implantations, ASD/PFO with and without the use of EchoNavigator System Release II.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startSep 2014
- Primary completion31 Dec 2018
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Imaging TechniquesStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Malte Kelm, MD, Study chair, Division of Cardiology, Pulmonary Disease and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608008
- Sponsor's protocol ID
- EchoNav
- Acronym
- EchoNav
- Status last verified
- Feb 2021
- First submitted
- 16 Nov 2015
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of EchoNavigator System Release II (Philips, Andover, MA) During Structural Heart Interventions
- ClinicalTrials.gov ID
- NCT02608008
- Acronym / sponsor ID
- EchoNav / EchoNav
- Conditions
- Cardiac Imaging Techniques
- Keywords
- 3D-Ultrasound, Live X-rays, EchoNavigator System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- Jun 2021 (estimated)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Data analysis transfemoral aortic valve implantation | – | Device: Data analysisPeriinterventional data analysis during structural heart procedures like transfemoral aortic valve implantation with and without the use of EchoNavigator System Release II. |
| Data analysis MitraClip | – | Device: Data analysisPeriinterventional data analysis during structural heart procedures like MitraClip Implantations with and without the use of EchoNavigator System Release II. |
| Data analysis PFO | – | Device: Data analysisPeriinterventional data analysis during structural heart procedures like PFO implantations with and without the use of EchoNavigator System Release II. |
| Data analysis ASD | – | Device: Data analysisPeriinterventional data analysis during structural heart procedures like ASD implantations with and without the use of EchoNavigator System Release II. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adult male or female patients of any ethnic origin aged > 18 years
- Signed and dated informed consent for the prospective study part
Key exclusion criteria (1 listed)
- < 18 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data analysisdata parameters Analysis | Device | Data analysis ASD, Data analysis MitraClip, Data analysis PFO, Data analysis transfemoral aortic valve implantation |
Primary outcome
Comparison of procedure time
Time frame: baseline
During interventions with and without the use of EchoNavigator System Release II
4 secondary outcomes
Comparison of area dose product
Time frame: baseline
Comparison of contrast agent amount
Time frame: baseline
Comparison of data measurements of fluoroscopy time
Time frame: baseline
Comparison of duration of the transeptal punction
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malte Kelm, MD study chair
Division of Cardiology, Pulmonary Disease and Vascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Imaging Techniques, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of procedure time (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.