Status:
COMPLETED
Novel Echocardiographic and Invasive Haemodynamic Measurements in the Assessment of Patients Low Flow Low Gradient Aortic Stenosis Undergoing TAVI
Lead Sponsor:
The Royal Wolverhampton Hospitals NHS Trust
Conditions:
Cardiovascular Abnormalities
Eligibility:
All Genders
Phase:
NA
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 res...
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 res...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05196815
Start Date
July 1 2022
End Date
March 1 2024
Last Update
January 6 2025
Active Locations (1)
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1
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom, WV10 0QP