Novel Echocardiographic and Invasive Haemodynamic Measurements in the Assessment of Patients Low Flow Low Gradient Aortic Stenosis Undergoing TAVI
NCT ID: NCT05196815
Last Updated: 2025-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2022-07-01
2024-03-01
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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The Royal Wolverhampton NHS Trust- New Cross Hospital
Ultrasound
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
Catheters
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).
Soft study wire
Participants will have a soft study wire inserted to measure the pressure in the left ventricle. This step is in addition to standard care.
X-ray
Participants will have chests x-ray when the soft study wire is inserted.
Dobutamine
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
Interventions
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Ultrasound
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
Catheters
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).
Soft study wire
Participants will have a soft study wire inserted to measure the pressure in the left ventricle. This step is in addition to standard care.
X-ray
Participants will have chests x-ray when the soft study wire is inserted.
Dobutamine
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
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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The Royal Wolverhampton Hospitals NHS Trust
OTHER_GOV
Responsible Party
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Principal Investigators
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James Cotton
Role: PRINCIPAL_INVESTIGATOR
The Royal Wolverhampton NHS Trust
Locations
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The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom
Countries
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Other Identifiers
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2021CAR121
Identifier Type: -
Identifier Source: org_study_id
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