Skip to main content
OpenTrials
Completed

NCT Number: NCT05196815

Novel Echocardiographic and Invasive Haemodynamic Measurements in the Assessment of Patients Low Flow Low Gradient Aortic Stenosis Undergoing TAVI

In this study the investigators will assess a variety of novel markers of heart strength (contractility) and assess whether they can give a clearer indication of how well patients with weak hearts respond to the TAVI procedure.

The investigators will perform a stress echocardiogram prior to each TAVI procedure and measure the global longitudinal strain (GLS) in the left ventricle (LV) heart muscle, a detailed marker of muscle strength.

The investigators will then proceed to the TAVI procedure and measure the contractility of the main pumping chamber in the heart before and after giving a very low dose of an adrenaline -like drug (dobutamine). The patient will already have received this short acting drug (at the same and higher doses) during their routine care planning stress echocardiogram.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

About this study

In this study the investigators will assess a variety of novel markers of heart strength (contractility) and assess whether they can give a clearer indication of how well patients with weak hearts respond to the TAVI procedure.

The investigators will perform a stress echocardiogram prior to each TAVI procedure and measure the global longitudinal strain (GLS) in the left ventricle (LV) heart muscle, a detailed marker of muscle strength.

The investigators will then proceed to the TAVI procedure and measure the contractility of the main pumping chamber in the heart before and after giving a very low dose of an adrenaline -like drug (dobutamine). The patient will already have received this short acting drug (at the same and higher doses) during their routine care planning stress echocardiogram.

The investigators will also measure the pressure across the aortic valve, known as the trans-aortic gradient, using the pressure wire (PW) and a standard (multipurpose) heart catheter. The investigators will repeat the resting measures (i.e. without pacing or dobutamine) at the end of the procedure to measure the early change in left ventricular contractility and then repeat the echocardiogram immediately and after 3 months to assess the outcome of the TAVI procedure in terms of left ventricular function volume and function

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients presenting symptomatic AS listed for TAVI
  • Native aortic valve disease
  • Ejection fraction </= 40%
  • Mean trans aortic gradient (echo) of <35 mmHg
  • AVA </= 1cm2
  • Able to give written informed consent prior to enrolment in the study
  • No contraindication to study procedures
  • CT scan confirmed severe AS
  • *Able and willing to return to the implanting site for the follow-up visits*

Exclusion criteria

  • Unable to provide formal written consent
  • Known pseudo-severe AS prior to TAVI
  • Known allergy to agents required for stress echocardiography
  • Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, Nitinol, or sensitivity to contrast media, which cannot be adequately premedicated. *
  • Any clinical contraindication to TAVI procedure

This pilot study will be restricted to English speaking subjects.

Treatment and study plan

ultrasound

Other

Participants will have a routine ultrasound of the heart (echocardiogram) before the procedure. During this test we will take a few extra measurements, this will not add any significant time to the scan

Catheters

Procedure

During the TAVI procedure 3 catheters (tubes) will be inserted into the blood vessels at the top of the participants legs as per normal standard care (there will be no extra skin punctures as part of the study).

Soft study wire

Procedure

Participants will have a soft study wire inserted to measure the pressure in the left ventricle. This step is in addition to standard care.

X-Ray

Radiation

Participants will have chests x-ray when the soft study wire is inserted.

Dobutamine

Drug

Participants will be given a low dose infusion of dobutamine, to make the heart pump quicker and more vigorously.. This will last for approximately 5 minutes

Primary outcomes

  1. Change in LV ejection fraction at 3 months compared to pre procedural readings.

    Time frame: 3 months

    Change in LV ejection fraction as a percentage

  2. Change in LV Volume at 3 months compared to pre procedural readings.

    Time frame: 3 months

    Change in LV Volume measured by BSA, mL/m2

  3. Change in global longitudinal strain at 3 months compared to pre procedural readings.

    Time frame: 3 months

    Change in global longitudinal strain measured by percentage

  4. Change in fractional shortening by echocardiography at 3 months compared to pre procedural readings.

    Time frame: 3 months

    Change in fractional shortening measured by percentage

  5. The change in contractility (dP/dT) with low dose dobutamine stress prior to TAVI, measured by invasive Pressure Wire

    Time frame: 3 months

    The change in contractility (dP/dT) with low dose dobutamine stress prior to TAVI, measured by invasive Pressure Wire

  6. The change in aortic trans-valvular gradient with low dose dobutamine stress during TAVI prior to AV treatment.

    Time frame: 3 months

    The change in aortic trans-valvular gradient measured by mmHg

  7. The change in contractility (dP/dT) from pre to post procedure at 3 months.

    Time frame: 3 months

    The change in derivative of pressure over time (dP/dT) is measured by the change in pressure per unit time. Measured ventricular pressure provides an indication of the contractility or relaxation of the ventricles of a heart. In this way, the derivative of pressure over time (dP/dt) provides a biphasic signal that can be used to evaluate acute directional changes of contractility

Sponsors and collaborators

Lead sponsor

The Royal Wolverhampton Hospitals NHS Trust

Other Gov

Registry information

Official study title

Utility of Novel Echocardiographic and Invasive Haemodynamic Measurements in the Assessment of Patients Low Flow Low Gradient Aortic Stenosis Undergoing TAVI

Acronym: LFLG

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2022
Registry last updated
Jan 6, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.