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OpenTrials
Completed

NCT Number: NCT04286893

Improved HRV, Inflammation Markers and Endothelial Function After TAVI

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.

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Key information

Conditions

Severe Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases TAVI Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UMC Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • TAVI

Exclusion criteria

  • stage V chronic kidney disease
  • active malignancies

Treatment and study plan

Flow mediated vasodilatation

Diagnostic Test

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

High resolution ECG

Diagnostic Test

Measurement HRV using high resolution ECG

Blood withdrawal

Diagnostic Test

Measurement of endothelial inflammation markers

Primary outcomes

  1. Change of heart rate variability

    Time frame: 3 to 6 months after TAVI

    Change of heart rate variability (HRV) estimated with digital high resolution ECG recording

  2. Change of laboratory value of endothelial inflammation markers

    Time frame: 3 to 6 months after TAVI

    Laboratory determined numerical changes in endothelial inflammation markers

  3. Change of flow-mediated filatation (FMD) of the brachial artery

    Time frame: 3 to 6 months after TAVI

    % flow-mediated dilatation

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Acronym: bTAVI

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2020
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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