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

The Royal Wolverhampton Hospitals NHS Trust

Status: Completed

Conditions: Cardiovascular Abnormalities

Treatments: Procedure: Soft study wire; Other: Ultrasound; Procedure: Catheters; Radiation: X-ray; Drug: Dobutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT05196815

2021CAR121

Details and patient eligibility

About

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.

Full 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

Enrollment: 7 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

The Royal Wolverhampton NHS Trust- New Cross Hospital

Experimental group

Treatment:

Drug: Dobutamine

Radiation: X-ray

Procedure: Catheters

Other: Ultrasound

Procedure: Soft study wire