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

Not Applicable

Completed

• Conditions: Cardiovascular Abnormalities
• Interventions: Other: Ultrasound; Procedure: Catheters; Procedure: Soft study wire; Radiation: X-ray; Drug: Dobutamine

• Registration Number: NCT05196815
• Lead Sponsor: The Royal Wolverhampton Hospitals NHS Trust

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

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-19
• Study Start: 2022-07-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The Royal Wolverhampton NHS Trust- New Cross Hospital	Catheters	-
The Royal Wolverhampton NHS Trust- New Cross Hospital	X-ray	-
The Royal Wolverhampton NHS Trust- New Cross Hospital	Ultrasound	-
The Royal Wolverhampton NHS Trust- New Cross Hospital	Soft study wire	-
The Royal Wolverhampton NHS Trust- New Cross Hospital	Dobutamine	-

Primary Outcome Measures

Name	Time	Method
The change in contractility (dP/dT) with low dose dobutamine stress prior to TAVI, measured by invasive Pressure Wire	3 months	The change in contractility (dP/dT) with low dose dobutamine stress prior to TAVI, measured by invasive Pressure Wire
The change in aortic trans-valvular gradient with low dose dobutamine stress during TAVI prior to AV treatment.	3 months	The change in aortic trans-valvular gradient measured by mmHg
Change in fractional shortening by echocardiography at 3 months compared to pre procedural readings.	3 months	Change in fractional shortening measured by percentage
Change in LV Volume at 3 months compared to pre procedural readings.	3 months	Change in LV Volume measured by BSA, mL/m2
Change in global longitudinal strain at 3 months compared to pre procedural readings.	3 months	Change in global longitudinal strain measured by percentage
Change in LV ejection fraction at 3 months compared to pre procedural readings.	3 months	Change in LV ejection fraction as a percentage
The change in contractility (dP/dT) from pre to post procedure at 3 months.	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

Trial Locations

Locations (1)

The Royal Wolverhampton NHS Trust; 🇬🇧 Wolverhampton, West Midlands, United Kingdom