Clinical trial NCT05196815: Novel Echocardiographic and Invasive Haemodynamic Measurements in the Assessment of Patients Low Flow Low Gradient Aortic Stenosis Undergoing TAVI
Official title: Utility of Novel Echocardiographic and Invasive Haemodynamic Measurements in the Assessment of Patients Low Flow Low Gradient Aortic Stenosis Undergoing TAVI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Abnormalities
Lead sponsor: The Royal Wolverhampton Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2022-01-19
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

This pilot study will be restricted to English speaking subjects.

Primary outcomes:
measure: Change in LV ejection fraction at 3 months compared to pre procedural readings.
timeFrame: 3 months
measure: Change in LV Volume at 3 months compared to pre procedural readings.
timeFrame: 3 months
measure: Change in global longitudinal strain at 3 months compared to pre procedural readings.
timeFrame: 3 months
measure: Change in fractional shortening by echocardiography at 3 months compared to pre procedural readings.
timeFrame: 3 months
measure: The change in contractility (dP/dT) with low dose dobutamine stress prior to TAVI, measured by invasive Pressure Wire
timeFrame: 3 months
measure: The change in aortic trans-valvular gradient with low dose dobutamine stress during TAVI prior to AV treatment.
timeFrame: 3 months
measure: The change in contractility (dP/dT) from pre to post procedure at 3 months.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
state: West Midlands
Study officials:
affiliation: The Royal Wolverhampton NHS Trust
name: James Cotton
role: PRINCIPAL_INVESTIGATOR
References: