Aortic Valve StenosisDEFINE-TAVRNCT05567809
Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement (DEFINE-TAVR) Study.
An observational study of Aortic Valve Stenosis, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to help understand how the replacement valve functions over time, both at rest and during exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2022to 21 Jan 2025
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: A minimum of 50 and up to 100 adults presenting with symptomatic severe aortic stenosis referred for clinically indicated TAVR at Yale New Haven Hospital who meet all eligibility criteria.
Who may be able to join
- Male or non-pregnant female ≥18 years of age
- Clinically indicated for TAVR
- Aortic annular size measures 21-25 mm diameter based on pre-procedure Computed Tomography Angiography (CTA)
- Able to exercise and, in the judgment of the investigator, is likely to be physically able to comply with the protocol requirements regarding exercise echocardiography
- Willing to comply with protocol-specified follow-up evaluations
- The participant or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
Who cannot join
- Previously implanted prosthetic aortic valve (i.e., planned valve-in-valve TAVR)
- Known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year
- Left ventricular ejection fraction (LVEF) <35%
- Presenting with cardiogenic shock at the time of the index procedure
- Planned to undergo any cardiac surgical procedure in the following 12 months
- The index procedure results in an unsuccessful TAVR, defined as procedural major adverse events (death, disabling stroke, or life-threatening or disabling bleeding), need for a second prosthesis implant, or conversion to emergent surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: DEFINE-TAVR (Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement) Study
The purpose of this study is to help understand how the replacement valve functions over time, both at rest and during exercise.
Read the detailed description
The objective of this single-center registry is to evaluate prosthetic valve hemodynamics and function over time in patients undergoing clinically indicated transcatheter aortic valve replacement (TAVR) for symptomatic severe aortic stenosis. Specific goals include:
- Describe valve hemodynamics at rest (baseline, post-procedure, 30 days, 1 year) and with exercise (at 30 days and 1 year) after TAVR implantation to define valve function and hemodynamics over time.
- Compare valve hemodynamics and function at rest and exercise between self-expanding and balloon expandable valves.
- Conditions
- Aortic Valve Stenosis
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
TransAortic Valve Gradient during exercise at 12 months post-TAVR
TransAortic Valve Gradient (mmHg) during exercise as assessed by the Echocardiographic Core Laboratory and summarized as peak and mean.
Measured: 12 months post-TAVR
Secondary outcomes (26)
Change in valve cusp thickness at rest
Change in valve cusp thickness (mm) at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in valve mobility at rest
Change in valve mobility at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in paravalvular leak at rest
Change in paravalvular leak at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in coefficient of contraction Effective Orifice Area (EOA)/Geometric Orifice Area (GOA) at rest
Change in coefficient of contraction EOA/GOA at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in Dimensionless Velocity Index (DVI) at rest
Change in DVI at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in energy loss coefficient at rest
Change in energy loss coefficient at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in EOA at rest
Change in EOA (cm2) at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in aortic valve gradient (peak and mean) at rest
Change in aortic valve gradient (mmHg) (peak and mean) at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in aortic valve velocity (peak and mean) at rest
Change in aortic valve velocity (m/s) (peak and mean) at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in Left Ventricle (LV) remodeling at rest
Change in LV remodeling at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in leaflet thickening at rest
Change in leaflet thickening at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in coaptation length at rest
Change in coaptation length (mm) at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in LV thickness at rest
Change in LV thickness (cm) at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in LV Global Longitudinal Strain at rest
Change in LV Global Longitudinal Strain (%) at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in Right Ventricular (RV) systolic velocity at rest
Change in RV systolic velocity (cm/s) at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in RV systolic pressure (RVSP) at rest
Change in RVSP (mmHg) at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) at rest
Change in TAPSE (mm) at rest assessed using echocardiogram reported as absolute values and as changes.
Measured: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in aortic valve gradient (peak and mean) with exercise
Change in gradient (mmHg) (peak and mean) with exercise assessed using echocardiogram reported as absolute values and as changes.
Measured: 30 days, and 12 months post-TAVR
Change in aortic valve velocity (peak and mean) with exercise
Change in aortic valve velocity (m/s) (peak and mean) with exercise assessed using echocardiogram reported as absolute values and as changes.
Measured: 30 days and 12 months post-TAVR
Change in DVI with exercise
Change in DVI with exercise assessed using echocardiogram reported as absolute values and as changes.
Measured: 30 days and 12 months post-TAVR
Change in EOA with exercise
Change in EOA (cm2) with exercise assessed using echocardiogram reported as absolute values and as changes.
Measured: 30 days and 12 months post-TAVR
Change in RVSP with exercise
Change in RVSP (mmHg) with exercise assessed using echocardiogram reported as absolute values and as changes.
Measured: 30 days and 12 months post-TAVR
Change in exercise duration
Change in exercise duration (min) reported as absolute values and as changes.
Measured: 30 days and 12 months post-TAVR
Change in LV Global Longitudinal Strain with exercise
Change in LV Global Longitudinal Strain (%) with exercise assessed using echocardiogram reported as absolute values and as changes.
Measured: 30 days and 12 months post-TAVR
TAVR Device Success (Valve Academic Research Consortium [VARC]-defined)
TAVR Device Success evaluated post-procedure/pre-discharge during hospitalization approximatively 3 days, defined as: absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomical location AND intended performance of the prosthetic heart valve (defined as no prosthesis-patient mismatch [VARC-defined] and mean aortic valve gradient <20 mm Hg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation [VARC-defined] [site and Core Laboratory-reported].
Measured: during hospitalization approximatively 3 days
Composite Safety Endpoints (VARC-3 defined)
Composite safety endpoint reported as a proportion of participants who died or experienced neurological events or life-threatening bleeding or acute kidney injury or coronary artery obstruction requiring intervention or major vascular complications or valve-related dysfunction requiring repeat procedure evaluated at 30 days and 12 months.
Measured: 30 days and 12 months post-TAVR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start25 Oct 2022
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Prospective
- Enrolment
- 28 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Anteris Technologies Corporation
- Responsible party
- Sponsor
- Investigators
- Amit Vora, MD, Principal investigator, Yale UniversityAlexandra J Lansky, MD, Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567809
- Sponsor's protocol ID
- 2000033211
- Other IDs
- YSI-002
- Acronym
- DEFINE-TAVR
- Status last verified
- Aug 2025
- First submitted
- 28 Sep 2022
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEFINE-TAVR (Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement) Study
- ClinicalTrials.gov ID
- NCT05567809
- Acronym / sponsor ID
- DEFINE-TAVR / 2000033211
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Anteris Technologies Corporation
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 5 Oct 2022 (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 purpose of this study is to help understand how the replacement valve functions over time, both at rest and during exercise.
Detailed description
The objective of this single-center registry is to evaluate prosthetic valve hemodynamics and function over time in patients undergoing clinically indicated transcatheter aortic valve replacement (TAVR) for symptomatic severe aortic stenosis. Specific goals include:
- Describe valve hemodynamics at rest (baseline, post-procedure, 30 days, 1 year) and with exercise (at 30 days and 1 year) after TAVR implantation to define valve function and hemodynamics over time.
- Compare valve hemodynamics and function at rest and exercise between self-expanding and balloon expandable valves.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A minimum of 50 and up to 100 adults presenting with symptomatic severe aortic stenosis referred for clinically indicated TAVR at Yale New Haven Hospital who meet all eligibility criteria.
Key inclusion criteria (6 listed)
- Male or non-pregnant female ≥18 years of age
- Clinically indicated for TAVR
- Aortic annular size measures 21-25 mm diameter based on pre-procedure Computed Tomography Angiography (CTA)
- Able to exercise and, in the judgment of the investigator, is likely to be physically able to comply with the protocol requirements regarding exercise echocardiography
- Willing to comply with protocol-specified follow-up evaluations
Key exclusion criteria (6 listed)
- Previously implanted prosthetic aortic valve (i.e., planned valve-in-valve TAVR)
- Known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year
- Left ventricular ejection fraction (LVEF) <35%
- Presenting with cardiogenic shock at the time of the index procedure
- Planned to undergo any cardiac surgical procedure in the following 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TransAortic Valve Gradient during exercise at 12 months post-TAVR
Time frame: 12 months post-TAVR
TransAortic Valve Gradient (mmHg) during exercise as assessed by the Echocardiographic Core Laboratory and summarized as peak and mean.
26 secondary outcomes
Change in valve cusp thickness at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in valve mobility at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in paravalvular leak at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in coefficient of contraction Effective Orifice Area (EOA)/Geometric Orifice Area (GOA) at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in Dimensionless Velocity Index (DVI) at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in energy loss coefficient at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in EOA at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in aortic valve gradient (peak and mean) at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in aortic valve velocity (peak and mean) at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in Left Ventricle (LV) remodeling at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in leaflet thickening at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in coaptation length at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in LV thickness at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in LV Global Longitudinal Strain at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in Right Ventricular (RV) systolic velocity at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in RV systolic pressure (RVSP) at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) at rest
Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Change in aortic valve gradient (peak and mean) with exercise
Time frame: 30 days, and 12 months post-TAVR
Change in aortic valve velocity (peak and mean) with exercise
Time frame: 30 days and 12 months post-TAVR
Change in DVI with exercise
Time frame: 30 days and 12 months post-TAVR
Change in EOA with exercise
Time frame: 30 days and 12 months post-TAVR
Change in RVSP with exercise
Time frame: 30 days and 12 months post-TAVR
Change in exercise duration
Time frame: 30 days and 12 months post-TAVR
Change in LV Global Longitudinal Strain with exercise
Time frame: 30 days and 12 months post-TAVR
TAVR Device Success (Valve Academic Research Consortium [VARC]-defined)
Time frame: during hospitalization approximatively 3 days
Composite Safety Endpoints (VARC-3 defined)
Time frame: 30 days and 12 months post-TAVR
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 11 Aug 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.
Amit Vora, MD principal investigator
Yale University
Alexandra J Lansky, MD study chair
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Yale University at 1 site in United States.
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 6 inclusion and 6 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 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Gradient during exercise at 12 months post-TAVR (time frame: 12 months post-TAVR). 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 11 Aug 2025.