Aortic StenosisNCT04827238
Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR (DISCORDANCE TAVR)
An observational study of Aortic Stenosis and Aortic Valve Stenosis, run by University of British Columbia at 9 sites in 2 countries.
Trial summary
The DISCORDANCE TAVR study will determine the discordance between echocardiography-derived and invasive transaortic gradients, as determined by a consistent and reproducible technique (Standardized Invasive Hemodynamics) post-TAVR. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis, Aortic Valve Stenosis
- What is being tested?
- Standardized Invasive Hemodynamics
- How many people
- 49 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 30 Aug 2021to 20 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients > 1 month post-transcatheter aortic valve replacement
Who may be able to join
- Echocardiographic transaortic mean gradient ≥ 20mmHg OR VARC-3 criteria for ≥ moderate hemodynamic valve deterioration post TAVR on any TTE > 1 month post-TAVR
- Consensus by the Heart Team that the patient is suitable for Standardized Invasive Hemodynamics (SIH).
Who cannot join
- CT demonstrating leaflet thrombosis or hypoattenuated leaflet thickening (HALT)
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
Tenet Health
Boca Raton, Florida, 33484
Massachusetts General Hospital
Boston, Massachusetts, 02114
eCommunity
Indianapolis, Indiana, 46256
Community Hospital
Munster, Indiana, 46321
William Beaumont Hospital
Southfield, Michigan, 48076
PIMA Heart Centre
Tucson, Arizona, 85712
Canada3 sites
McMaster University
Hamilton, Ontario, L8S 4L8
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Standardized Invasive Hemodynamics for Monitoring Acute and Long Term Valve Performance in Patients With Elevated Gradients Post Transcatheter Aortic Valve Replacement
The DISCORDANCE TAVR study will determine the discordance between echocardiography-derived and invasive transaortic gradients, as determined by a consistent and reproducible technique (Standardized Invasive Hemodynamics) post-TAVR.
Read the detailed description
Since the introduction of Doppler echocardiography, non-invasive estimation of aortic valve gradients through modification and simplification of the Bernoulli equation and derivation of the AVA, via the continuity equation, have become the primary method to assess the severity of AS.
The utility of echocardiography to successfully determine aortic valve gradients and AVA has been established in the presence of AS, and such observations have been extrapolated to prosthetic valves. However, several reports following SAVR and TAVR for both native and valve-in-valve have demonstrated significant discordance between echocardiography-derived and direct invasive measurements of aortic valve mean gradients.
The indexed AVA (iAVA) is derived from the stroke volume indexed to the BSA. The stroke volume index (SVI) divided by the Doppler velocity time integral of the continuous wave aortic valve spectral profile, is used to determine the presence of severe PPM. As such, a low iAVA may occur due to a low flow state defined by a reduced SVI (<35 ml/m2) or a reduced stroke flow rate (< 200 ml/second) and calculated by dividing the SV by the ejection time spuriously increasing the incidence of severe PPM. A low indexed effective orifice area due to a low SVI, in the absence of intrinsic PPM, has been referred to as "pseudo-severe PPM", but the impact of flow state on PPM has not been described.
Nonetheless, echocardiographic thresholds for the evaluation of prosthetic valve performance after TAVR have been widely adopted: mean-gradient > 20mmHg, severe PPM as defined by an iAVA < 0.65 cm2/m2, and AR, including paravalvular and transvalvular AR of moderate or greater severity. These criteria are suggested to indicate procedural success and predict long-term clinical outcomes (12). Practically many centers utilize an echocardiography-derived mean gradient for the follow-up of transcatheter heart valves. While the association of at least moderate paravalvular AR with mortality has been consistently demonstrated, there remains uncertainty regarding the clinical impact of severe PPM as determined by index echocardiography. Furthermore, the magnitude of discordance between echocardiography-derived and invasive aortic valve mean-gradients post TAVR is unknown and it remains unclear how to reconcile measurement discordances in clinical practice. These potential differences may have an important impact on patient management post TAVR.
The DISCORDANCE TAVR study will determine the discordance between echocardiography-derived and invasive transaortic gradients, as determined by a consistent and reproducible technique (Standardized Invasive Hemodynamics) post-TAVR.
- Conditions
- Aortic Stenosis, Aortic Valve Stenosis
- Being tested
- Standardized Invasive Hemodynamics
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Invasive HemodynamicsDiagnostic test
The SIH technique is a standardized, reproducible and efficient way of obtaining hemodynamic measurements.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Elevated Gradients Post Transcatheter Aortic Valve Replacement | Patients who have an echocardiographic transaortic mean gradient ≥ 20mmHg OR VARC-3 criteria for ≥ moderate hemodynamic valve deterioration post TAVR on any TTE > 1 month post-TAVR Receives: Diagnostic Test: Standardized Invasive Hemodynamics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transaortic valve gradients
Transaortic valve gradients measured by echocardiography and direct invasive methods
Measured: 30 days
Transaortic mean gradient reclassification
Proportion of patients reclassified to a transaortic mean gradient < 20mmHg using direct invasive methods
Measured: 30 days
VARC-3 hemodynamic valve deterioration reclassification
Proportion of patients reclassified to ≤ moderate VARC-3 hemodynamic valve deterioration using direct invasive methods, including mean gradient and valve area, compared to echocardiography
Measured: 30 days
Patient-Prosthesis Mismatch (PPM) reclassification
Proportion of patients with echocardiographic severe PPM reclassified as non-severe PPM using direct invasive methods
Measured: 30 days
Secondary outcomes (2)
Total procedure time
Total procedure time (mins) to complete standardized invasive hemodynamics
Measured: 30 days
Risks of procedural complications
Evaluate risks of procedural complications associated with direct-invasive hemodynamics
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start30 Aug 2021
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, David Wood, University of British Columbia
- Investigators
- David Wood, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827238
- Sponsor's protocol ID
- H21-00824
- Status last verified
- Jul 2025
- First submitted
- 29 Mar 2021
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Invasive Hemodynamics for Monitoring Acute and Long Term Valve Performance in Patients With Elevated Gradients Post Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT04827238
- Acronym / sponsor ID
- H21-00824
- Conditions
- Aortic Stenosis, Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The DISCORDANCE TAVR study will determine the discordance between echocardiography-derived and invasive transaortic gradients, as determined by a consistent and reproducible technique (Standardized Invasive Hemodynamics) post-TAVR.
Detailed description
Since the introduction of Doppler echocardiography, non-invasive estimation of aortic valve gradients through modification and simplification of the Bernoulli equation and derivation of the AVA, via the continuity equation, have become the primary method to assess the severity of AS.
The utility of echocardiography to successfully determine aortic valve gradients and AVA has been established in the presence of AS, and such observations have been extrapolated to prosthetic valves. However, several reports following SAVR and TAVR for both native and valve-in-valve have demonstrated significant discordance between echocardiography-derived and direct invasive measurements of aortic valve mean gradients.
The indexed AVA (iAVA) is derived from the stroke volume indexed to the BSA. The stroke volume index (SVI) divided by the Doppler velocity time integral of the continuous wave aortic valve spectral profile, is used to determine the presence of severe PPM. As such, a low iAVA may occur due to a low flow state defined by a reduced SVI (<35 ml/m2) or a reduced stroke flow rate (< 200 ml/second) and calculated by dividing the SV by the ejection time spuriously increasing the incidence of severe PPM. A low indexed effective orifice area due to a low SVI, in the absence of intrinsic PPM, has been referred to as "pseudo-severe PPM", but the impact of flow state on PPM has not been described.
Nonetheless, echocardiographic thresholds for the evaluation of prosthetic valve performance after TAVR have been widely adopted: mean-gradient > 20mmHg, severe PPM as defined by an iAVA < 0.65 cm2/m2, and AR, including paravalvular and transvalvular AR of moderate or greater severity. These criteria are suggested to indicate procedural success and predict long-term clinical outcomes (12). Practically many centers utilize an echocardiography-derived mean gradient for the follow-up of transcatheter heart valves. While the association of at least moderate paravalvular AR with mortality has been consistently demonstrated, there remains uncertainty regarding the clinical impact of severe PPM as determined by index echocardiography. Furthermore, the magnitude of discordance between echocardiography-derived and invasive aortic valve mean-gradients post TAVR is unknown and it remains unclear how to reconcile measurement discordances in clinical practice. These potential differences may have an important impact on patient management post TAVR.
The DISCORDANCE TAVR study will determine the discordance between echocardiography-derived and invasive transaortic gradients, as determined by a consistent and reproducible technique (Standardized Invasive Hemodynamics) post-TAVR.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Elevated Gradients Post Transcatheter Aortic Valve Replacement | – | Diagnostic Test: Standardized Invasive HemodynamicsPatients who have an echocardiographic transaortic mean gradient ≥ 20mmHg OR VARC-3 criteria for ≥ moderate hemodynamic valve deterioration post TAVR on any TTE > 1 month post-TAVR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients > 1 month post-transcatheter aortic valve replacement
Key inclusion criteria (2 listed)
- Echocardiographic transaortic mean gradient ≥ 20mmHg OR VARC-3 criteria for ≥ moderate hemodynamic valve deterioration post TAVR on any TTE > 1 month post-TAVR
- Consensus by the Heart Team that the patient is suitable for Standardized Invasive Hemodynamics (SIH).
Key exclusion criteria (1 listed)
- CT demonstrating leaflet thrombosis or hypoattenuated leaflet thickening (HALT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Invasive HemodynamicsThe SIH technique is a standardized, reproducible and efficient way of obtaining hemodynamic measurements. | Diagnostic test | Patients with Elevated Gradients Post Transcatheter Aortic Valve Replacement |
Primary outcome
Transaortic valve gradients
Time frame: 30 days
Transaortic valve gradients measured by echocardiography and direct invasive methods
Transaortic mean gradient reclassification
Time frame: 30 days
Proportion of patients reclassified to a transaortic mean gradient < 20mmHg using direct invasive methods
VARC-3 hemodynamic valve deterioration reclassification
Time frame: 30 days
Proportion of patients reclassified to ≤ moderate VARC-3 hemodynamic valve deterioration using direct invasive methods, including mean gradient and valve area, compared to echocardiography
Patient-Prosthesis Mismatch (PPM) reclassification
Time frame: 30 days
Proportion of patients with echocardiographic severe PPM reclassified as non-severe PPM using direct invasive methods
2 secondary outcomes
Total procedure time
Time frame: 30 days
Risks of procedural complications
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wood, MD principal investigator
University of British Columbia
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Aortic Valve Stenosis, run by University of British Columbia at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transaortic valve gradients (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.