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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 March 2021 |
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Main ID: |
NCT02608008 |
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Date of registration:
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16/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of EchoNavigator System Release II During Structural Heart Interventions
EchoNav |
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Scientific title:
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Safety and Efficacy of EchoNavigator System Release II (Philips, Andover, MA) During Structural Heart Interventions |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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500 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02608008 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Malte Kelm, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Cardiology, Pulmonary Disease and Vascular Medicine |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cardiac Imaging Techniques
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Intervention(s)
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Device: Data analysis
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Primary Outcome(s)
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Comparison of procedure time
[Time Frame: baseline]
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Secondary Outcome(s)
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Comparison of duration of the transeptal punction
[Time Frame: baseline]
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Comparison of contrast agent amount
[Time Frame: baseline]
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Comparison of data measurements of fluoroscopy time
[Time Frame: baseline]
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Comparison of area dose product
[Time Frame: baseline]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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