NCT03088787|UnknownFDA Device
Feasibility of Continuous Noninvasive Finger Arterial Blood Pressure Measurement for Detection and Staging of Aortic Stenosis
COaRt
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COaRt
Sponsor study identifier
observational
100
1 country
1
Study Start
April 1, 2017
Actual (reported)Primary Completion
October 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The primary purpose of this study is electronic data collection of arterial pressure waveform signals in patients with Aortic Stenosis. The collected digital pressure waveform data will be used to assess the feasibility of using the arterial pressure signal as a decision support tool for early detection of aortic stenosis conditions. Furthermore we evaluate hemodynamic parameters before and after valve repair and its correlation with outcome.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 17, 2017
Actual (reported)March 23, 2017
Actual (reported)April 1, 2017
Actual (reported)October 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
the distinctive morphological characteristics of the aortic pressure waveform
the distinctive morphological characteristics of the aortic pressure waveform
During procedure and 4 hours after
changes in hemodynamic variables after TAVR and its influence on cardiac recovery.
during procedure and up to 6 weeks after intervention
Patients for TAVR
There will be only observational recordings, no interevntion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) procedures
Veelo
Amsterdam, Netherlands
Kho E, Schenk J, Vlaar APJ, Vis MM, Wijnberge M, Stam LB, van Mourik M, Jorstad HT, Hermanns H, Westerhof BE, Veelo DP, van der Ster BJP. Detecting aortic valve stenosis based on the non-invasive blood pressure waveform-a proof of concept study. Geroscience. 2024 Dec;46(6):5955-5965. doi: 10.1007/s11357-024-01136-w. Epub 2024 Mar 20.
Schenk J, Kho E, Rellum S, Kromhout J, Vlaar APJ, Baan J, van Mourik MS, Jorstad HT, van der Ster BJP, Westerhof BE, Bruns S, Immink RV, Vis MM, Veelo DP. Immediate reduction in left ventricular ejection time following TAVI is associated with improved quality of life. Front Cardiovasc Med. 2022 Sep 16;9:988840. doi: 10.3389/fcvm.2022.988840. eCollection 2022.
First Submitted
March 17, 2017
First Posted
March 23, 2017
Study Start
April 1, 2017
Actual (reported)Primary Completion
October 2018
Estimated (date passed)Pressure Assessment to Improve Outcomes After TAVR: a Registry
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 8, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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