Novel Echocardiographic and Invasive Haemodynamic Measurements in the Assessment of Patients Low … (NCT05196815) | Clinical Trial Compass
CompletedNot Applicable
Novel Echocardiographic and Invasive Haemodynamic Measurements in the Assessment of Patients Low Flow Low Gradient Aortic Stenosis Undergoing TAVI
United Kingdom7 participantsStarted 2022-07-01
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in LV ejection fraction at 3 months compared to pre procedural readings.
Timeframe: 3 months
2
Change in LV Volume at 3 months compared to pre procedural readings.
Timeframe: 3 months
3
Change in global longitudinal strain at 3 months compared to pre procedural readings.
Timeframe: 3 months
4
Change in fractional shortening by echocardiography at 3 months compared to pre procedural readings.
Timeframe: 3 months
5
The change in contractility (dP/dT) with low dose dobutamine stress prior to TAVI, measured by invasive Pressure Wire
Timeframe: 3 months
6
The change in aortic trans-valvular gradient with low dose dobutamine stress during TAVI prior to AV treatment.
Timeframe: 3 months
7
The change in contractility (dP/dT) from pre to post procedure at 3 months.
Timeframe: 3 months
Trial details
NCT IDNCT05196815
SponsorThe Royal Wolverhampton Hospitals NHS Trust
. 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. \*