search
Back to results

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

Primary Purpose

Cardiovascular Abnormalities

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ultrasound
Catheters
Soft study wire
X-ray
Dobutamine
Sponsored by
The Royal Wolverhampton Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Abnormalities

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Royal Wolverhampton NHS TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The Royal Wolverhampton NHS Trust- New Cross Hospital

Arm Description

Outcomes

Primary Outcome Measures

Change in LV ejection fraction at 3 months compared to pre procedural readings.
Change in LV ejection fraction as a percentage
Change in LV Volume at 3 months compared to pre procedural readings.
Change in LV Volume measured by BSA, mL/m2
Change in global longitudinal strain at 3 months compared to pre procedural readings.
Change in global longitudinal strain measured by percentage
Change in fractional shortening by echocardiography at 3 months compared to pre procedural readings.
Change in fractional shortening measured by percentage
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
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
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

Secondary Outcome Measures

Full Information

First Posted
December 14, 2021
Last Updated
July 26, 2022
Sponsor
The Royal Wolverhampton Hospitals NHS Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT05196815
Brief Title
Novel Echocardiographic and Invasive Haemodynamic Measurements in the Assessment of Patients Low Flow Low Gradient Aortic Stenosis Undergoing TAVI
Acronym
LFLG
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Wolverhampton Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Abnormalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The Royal Wolverhampton NHS Trust- New Cross Hospital
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Ultrasound
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Catheters
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Soft study wire
Intervention Description
Participants will have a soft study wire inserted to measure the pressure in the left ventricle. This step is in addition to standard care.
Intervention Type
Radiation
Intervention Name(s)
X-ray
Intervention Description
Participants will have chests x-ray when the soft study wire is inserted.
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in LV ejection fraction at 3 months compared to pre procedural readings.
Description
Change in LV ejection fraction as a percentage
Time Frame
3 months
Title
Change in LV Volume at 3 months compared to pre procedural readings.
Description
Change in LV Volume measured by BSA, mL/m2
Time Frame
3 months
Title
Change in global longitudinal strain at 3 months compared to pre procedural readings.
Description
Change in global longitudinal strain measured by percentage
Time Frame
3 months
Title
Change in fractional shortening by echocardiography at 3 months compared to pre procedural readings.
Description
Change in fractional shortening measured by percentage
Time Frame
3 months
Title
The change in contractility (dP/dT) with low dose dobutamine stress prior to TAVI, measured by invasive Pressure Wire
Description
The change in contractility (dP/dT) with low dose dobutamine stress prior to TAVI, measured by invasive Pressure Wire
Time Frame
3 months
Title
The change in aortic trans-valvular gradient with low dose dobutamine stress during TAVI prior to AV treatment.
Description
The change in aortic trans-valvular gradient measured by mmHg
Time Frame
3 months
Title
The change in contractility (dP/dT) from pre to post procedure at 3 months.
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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* Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
james Cotton
Phone
01902307999
Email
jamescotton@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Cotton
Organizational Affiliation
The Royal Wolverhampton NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Wolverhampton NHS Trust
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Cotton
Email
jamescotton@nhs.net

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs