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

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Royal Wolverhampton Hospitals NHS Trust
• Treatments: Dobutamine

Criteria

Inclusion Criteria:

1. Patients presenting symptomatic AS listed for TAVI

2. Native aortic valve disease

3. Ejection fraction

4. Mean trans aortic gradient (echo) of <35 mmHg

5. AVA

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.