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Improved HRV, Inflammation Markers and Endothelial Function After TAVI

Improved Heart Rate Variability, Inflammation Markers and Endothelial Function After Transcatheter Aortic Valve Implantation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04286893
Acronym
bTAVI
Enrollment
50
Registered
2020-02-27
Start date
2019-07-09
Completion date
2020-07-31
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Aortic Stenosis, TAVI

Brief summary

Severe aortic valve stenosis is known to affect heart haemodynamics, endothelial function and body inflammation markers. Our aim is to investigate the weather transcatheter aortic valve implantation in patients with severe aortic stenosis affects heart rate variability, inflammation markers and endothelial function.

Interventions

DIAGNOSTIC_TESTFlow mediated vasodilatation

Measurement of brachial artery diameter change before and after limb ischaemia.

DIAGNOSTIC_TESTHigh resolution ECG

Measurement HRV using high resolution ECG

DIAGNOSTIC_TESTBlood withdrawal

Measurement of endothelial inflammation markers

Sponsors

University Medical Centre Ljubljana
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* TAVI

Exclusion criteria

* stage V chronic kidney disease * active malignancies

Design outcomes

Primary

MeasureTime frameDescription
Change of heart rate variability3 to 6 months after TAVIChange of heart rate variability (HRV) estimated with digital high resolution ECG recording
Change of laboratory value of endothelial inflammation markers3 to 6 months after TAVILaboratory determined numerical changes in endothelial inflammation markers
Change of flow-mediated filatation (FMD) of the brachial artery3 to 6 months after TAVI% flow-mediated dilatation

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026