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

NCT05196815 | Completed

• 1 other identifier: 2021CAR121
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Abnormalities

Outcome Measures

Primary Outcomes (7)

• Change in LV ejection fraction at 3 months compared to pre procedural readings.

  Change in LV ejection fraction as a percentage

  3 months

• Change in LV Volume at 3 months compared to pre procedural readings.

  Change in LV Volume measured by BSA, mL/m2

  3 months

• Change in global longitudinal strain at 3 months compared to pre procedural readings.

  Change in global longitudinal strain measured by percentage

  3 months

• Change in fractional shortening by echocardiography at 3 months compared to pre procedural readings.

  Change in fractional shortening measured by percentage

  3 months

• The change in contractility (dP/dT) with low dose dobutamine stress prior to TAVI, measured by invasive Pressure Wire

  The change in contractility (dP/dT) with low dose dobutamine stress prior to TAVI, measured by invasive Pressure Wire

  3 months

• The change in aortic trans-valvular gradient with low dose dobutamine stress during TAVI prior to AV treatment.

  The change in aortic trans-valvular gradient measured by mmHg

  3 months

• The change in contractility (dP/dT) from pre to post procedure at 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

  3 months

Study Arms (1)

The Royal Wolverhampton NHS Trust- New Cross Hospital

EXPERIMENTAL

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

Interventions

Ultrasound OTHER

Participants will have a routine ultrasound of the heart (echocardiogram) before the procedure. During this test we will take a few extra measurements, this will not add any significant time to the scan

The Royal Wolverhampton NHS Trust- New Cross Hospital

Catheters PROCEDURE

During the TAVI procedure 3 catheters (tubes) will be inserted into the blood vessels at the top of the participants legs as per normal standard care (there will be no extra skin punctures as part of the study).

The Royal Wolverhampton NHS Trust- New Cross Hospital

Soft study wire PROCEDURE

Participants will have a soft study wire inserted to measure the pressure in the left ventricle. This step is in addition to standard care.

The Royal Wolverhampton NHS Trust- New Cross Hospital

X-ray RADIATION

Participants will have chests x-ray when the soft study wire is inserted.

The Royal Wolverhampton NHS Trust- New Cross Hospital

Dobutamine DRUG

Participants will be given a low dose infusion of dobutamine, to make the heart pump quicker and more vigorously.. This will last for approximately 5 minutes

The Royal Wolverhampton NHS Trust- New Cross Hospital

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \*Able and willing to return to the implanting site for the follow-up visits\*

You may not qualify if:

• Unable to provide formal written consent
• Known pseudo-severe AS prior to TAVI
• 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. \*
• Any clinical contraindication to TAVI procedure
• This pilot study will be restricted to English speaking subjects.

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Abnormalities

Interventions

High-Energy Shock Waves; Catheters; X-Rays; Dobutamine

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Equipment and Supplies; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Radiation, Ionizing; Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• James Cotton

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 19, 2022
• Study Start: July 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

GB (1)