An interventional study of Ultrasound and Catheters in Cardiovascular Abnormalities, sponsored by The Royal Wolverhampton Hospitals NHS Trust. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by The Royal Wolverhampton Hospitals NHS Trust · Not applicable, Interventional, and Treatment
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.
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
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 7 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →The Royal Wolverhampton Hospitals NHS Trust is the lead sponsor of 49 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This pilot study will be restricted to English speaking subjects.
Other: Ultrasound · Procedure: Catheters · Procedure: Soft study wire · Radiation: X-ray · Drug: Dobutamine
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
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).
Participants will have a soft study wire inserted to measure the pressure in the left ventricle. This step is in addition to standard care.
Participants will have chests x-ray when the soft study wire is inserted.
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
Change in LV ejection fraction at 3 months compared to pre procedural readings.
Change in LV ejection fraction as a percentage
Time frame: 3 months
Change in LV Volume at 3 months compared to pre procedural readings.
Change in LV Volume measured by BSA, mL/m2
Time frame: 3 months
Change in global longitudinal strain at 3 months compared to pre procedural readings.
Change in global longitudinal strain measured by percentage
Time frame: 3 months
Change in fractional shortening by echocardiography at 3 months compared to pre procedural readings.
Change in fractional shortening measured by percentage
Time frame: 3 months
The change in contractility (dP/dT) with low dose dobutamine stress prior to TAVI, measured by invasive Pressure Wire
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 aortic trans-valvular gradient with low dose dobutamine stress during TAVI prior to AV treatment.
The change in aortic trans-valvular gradient measured by mmHg
Time frame: 3 months
The change in contractility (dP/dT) from pre to post procedure at 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
Time frame: 3 months
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Royal Wolverhampton Hospitals NHS Trust