Aortic StenosisNCT03423459
CoreValve Evolut Pro Prospective Registry
An observational study of Aortic Stenosis, run by Medstar Health Research Institute at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective observational registry. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- TAVR
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jan 2018to 31 Dec 2024
- 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 50 years and older
- All sexes
- Adult, Older adult
Study population: This study is a prospective registry of subjects with symptomatic severe aortic stenosis undergoing TAVR with a commercially-approved self-expanding transcatheter heart valve. A subgroup of subjects will undergo additional research contrast-enhanced 4D CT at 30-60 days after TAVR. Otherwise, all additional test and TAVR implantation procedures are as per standard of care.
Who may be able to join
- Symptomatic severe aortic stenosis
- Intermediate, high or extreme surgical risk
- The institutional Heart Team determines that transcatheter aortic valve replacement with an Evolut Pro device is appropriate
Who cannot join
- Subject unable or unwilling to give informed consent
- For subjects in the CT arm only, renal function precluding the administration of iodinated contrast for cardiac CT (eGFR < 30 ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media.
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medstar Union Memorial Hospital
Baltimore, Maryland, 21218
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
The primary objective of this study is to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective observational registry.
Read the detailed description
The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. This latest generation device features an outer wrap to improve annular sealing and reduce paravalvular leak.
In this observational study, baseline demographic and imaging characteristics, procedural details and clinical outcomes of patients undergoing transcatheter aortic valve replacement with the CoreValve Evolut PRO will be prospectively collected into a registry database. The institutional Heart Team will select patients according to standard practice.
- Conditions
- Aortic Stenosis
- Being tested
- TAVR
- 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.
TAVRDevice
Transcatheter Aortic Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| CT Cohort | 1. Compare the rate of ≥mild PVL in patients with none/mild versus moderate/severe LVOT calcification.
2. Comparison of the rate of PPM implantation in patients with none/mild versus moderate/severe LVOT calcification.
3. Determine how the Evolut PRO conforms to LVOT calcification.
4. Compare the impact of LVOT calcification on the implantation depth of the Evolut PRO.
5. Analyze the interaction and geometry of the Evolut PRO in patients with moderate/severe LVOT calcification.
6. Assess for leaflet thickening, subclinical leaflet thrombosis and/or restricted leaflet motion 30-60 days after TAVR. Receives: Device: TAVR | |
| Non-CT Cohort | 1. Compare the rate of ≥mild PVL with the Evolut PRO with a propensity score matched cohort of historical control subjects who underwent TAVR with the Evolut R and/or CoreValve within the MedStar Health System.
2. Determine which features of LVOT calcification (volume, location relative to aortic annulus and sinuses, prominence into the LVOT lumen) predict ≥mild PVL.
3. Determine which features of LVOT calcification (volume, location relative to aortic annulus and sinuses, prominence into the LVOT lumen) predict PPM implantation. Receives: Device: TAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device success:
Absence of procedural mortality Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient<20 mm Hg or peak velocity<3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Measured: 30 days
All Cause Mortality
all causes of death
Measured: 30 days
All Stroke (disabling and non-disabling
Stroke will evaluated using the VARC-2 definition
Measured: 30 days
Life Threatening Bleeding
Life Threatening Bleeding will be evaluated using the VARC-2 definition
Measured: 30 Days
Acute Kidney Injury Stage 2 or 3
AKI will be evaluated using the VARC-2 definition of Stage 2 or 3 AKI
Measured: 30 days
Coronary Artery Obstruction requiring intervention
This will be assessed if by noting whether the patient has a re intervention
Measured: 30 days
Major Vascular Complication
Major Vascular Complication will be evaluated using the VARC-2 definition of Major Vascular Complication
Measured: 30 days
Valve - related Dysfunction
Valve related dysfunction will be evaluated by determining whether the subject has a repeat procedure such as a BAV, TAVI, or SAVR
Measured: 30 Days
Secondary outcomes (6)
Prosthetic valve dysfunction #1
Mean aortic valve gradient ≥20 mm Hg
Measured: 1 year
Prosthetic valve dysfunction #2
Moderate-severe transvalvular aortic regurgitation as determined by the echo core lab
Measured: 1 year
Prosthetic valve dysfunction #3
Abnormal leaflet thickening on CT as determined by the CT Core lab
Measured: 1 year
Prosthetic valve dysfunction #4
Decreased leaflet mobility on CT as determined by the CT Core lab
Measured: 1 year
Prosthetic valve dysfunction
Leaflet thrombosis on CT as determined by the CT Core lab
Measured: 1 year
Reduction in PVL
This will be evaluated by echo core lab findings
Measured: Discharge thru to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start18 Jan 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Cardiovascular
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423459
- Sponsor's protocol ID
- EPROMPT
- Status last verified
- May 2023
- First submitted
- 18 Jan 2018
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Merdler I, Case BC, Bhogal S, Reddy PK, Zhang C, Ali S, Gallino PE, Jackman C, Ben-Dor I, Satler LF, Cohen JE, Rogers T, Waksman R. Temporal trends with the Evolut family of self-expanding transcatheter heart valves: A single-center experience. Catheter Cardiovasc Interv. 2024 Jul;104(1):125-133. doi: 10.1002/ccd.31088. Epub 2024 May 20.
PubMed 38769727Medranda GA, Soria Jimenez CE, Torguson R, Case BC, Forrestal BJ, Ali SW, Shea C, Zhang C, Wang JC, Gordon P, Ehsan A, Wilson SR, Levitt R, Parikh P, Bilfinger T, Hanna N, Buchbinder M, Asch FM, Weissman G, Shults CC, Garcia-Garcia HM, Ben-Dor I, Satler LF, Waksman R, Rogers T. Lifetime management of patients with symptomatic severe aortic stenosis: a computed tomography simulation study. EuroIntervention. 2022 Aug 5;18(5):e407-e416. doi: 10.4244/EIJ-D-21-01091.
PubMed 35321859Forrestal BJ, Case BC, Yerasi C, Shea C, Torguson R, Zhang C, Ben-Dor I, Deksissa T, Ali S, Satler LF, Shults C, Weissman G, Wang JC, Khan JM, Waksman R, Rogers T. Risk of Coronary Obstruction and Feasibility of Coronary Access After Repeat Transcatheter Aortic Valve Replacement With the Self-Expanding Evolut Valve: A Computed Tomography Simulation Study. Circ Cardiovasc Interv. 2020 Dec;13(12):e009496. doi: 10.1161/CIRCINTERVENTIONS.120.009496. Epub 2020 Dec 4.
PubMed 33272031
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoreValve Evolut Pro Prospective Registry
- ClinicalTrials.gov ID
- NCT03423459
- Acronym / sponsor ID
- EPROMPT
- Conditions
- Aortic Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Medtronic Cardiovascular
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Feb 2018 (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 primary objective of this study is to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective observational registry.
Detailed description
The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. This latest generation device features an outer wrap to improve annular sealing and reduce paravalvular leak.
In this observational study, baseline demographic and imaging characteristics, procedural details and clinical outcomes of patients undergoing transcatheter aortic valve replacement with the CoreValve Evolut PRO will be prospectively collected into a registry database. The institutional Heart Team will select patients according to standard practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT Cohort | – | Device: TAVR1. Compare the rate of ≥mild PVL in patients with none/mild versus moderate/severe LVOT calcification. 2. Comparison of the rate of PPM implantation in patients with none/mild versus moderate/severe LVOT calcification. 3. Determine how the Evolut PRO conforms to LVOT calcification. 4. Compare the impact of LVOT calcification on the implantation depth of the Evolut PRO. 5. Analyze the interaction and geometry of the Evolut PRO in patients with moderate/severe LVOT calcification. 6. Assess for leaflet thickening, subclinical leaflet thrombosis and/or restricted leaflet motion 30-60 days after TAVR. |
| Non-CT Cohort | – | Device: TAVR1. Compare the rate of ≥mild PVL with the Evolut PRO with a propensity score matched cohort of historical control subjects who underwent TAVR with the Evolut R and/or CoreValve within the MedStar Health System. 2. Determine which features of LVOT calcification (volume, location relative to aortic annulus and sinuses, prominence into the LVOT lumen) predict ≥mild PVL. 3. Determine which features of LVOT calcification (volume, location relative to aortic annulus and sinuses, prominence into the LVOT lumen) predict PPM implantation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study is a prospective registry of subjects with symptomatic severe aortic stenosis undergoing TAVR with a commercially-approved self-expanding transcatheter heart valve. A subgroup of subjects will undergo additional research contrast-enhanced 4D CT at 30-60 days after TAVR. Otherwise, all additional test and TAVR implantation procedures are as per standard of care.
Key inclusion criteria (3 listed)
- Symptomatic severe aortic stenosis
- Intermediate, high or extreme surgical risk
- The institutional Heart Team determines that transcatheter aortic valve replacement with an Evolut Pro device is appropriate
Key exclusion criteria (3 listed)
- Subject unable or unwilling to give informed consent
- For subjects in the CT arm only, renal function precluding the administration of iodinated contrast for cardiac CT (eGFR < 30 ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media.
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
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 |
|---|---|---|
| TAVRTranscatheter Aortic Valve Replacement | Device | CT Cohort, Non-CT Cohort |
Primary outcome
Device success:
Time frame: 30 days
Absence of procedural mortality Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient<20 mm Hg or peak velocity<3 m/s, AND no moderate or severe prosthetic valve regurgitation)
All Cause Mortality
Time frame: 30 days
all causes of death
All Stroke (disabling and non-disabling
Time frame: 30 days
Stroke will evaluated using the VARC-2 definition
Life Threatening Bleeding
Time frame: 30 Days
Life Threatening Bleeding will be evaluated using the VARC-2 definition
Acute Kidney Injury Stage 2 or 3
Time frame: 30 days
AKI will be evaluated using the VARC-2 definition of Stage 2 or 3 AKI
Coronary Artery Obstruction requiring intervention
Time frame: 30 days
This will be assessed if by noting whether the patient has a re intervention
Major Vascular Complication
Time frame: 30 days
Major Vascular Complication will be evaluated using the VARC-2 definition of Major Vascular Complication
Valve - related Dysfunction
Time frame: 30 Days
Valve related dysfunction will be evaluated by determining whether the subject has a repeat procedure such as a BAV, TAVI, or SAVR
6 secondary outcomes
Prosthetic valve dysfunction #1
Time frame: 1 year
Prosthetic valve dysfunction #2
Time frame: 1 year
Prosthetic valve dysfunction #3
Time frame: 1 year
Prosthetic valve dysfunction #4
Time frame: 1 year
Prosthetic valve dysfunction
Time frame: 1 year
Reduction in PVL
Time frame: Discharge thru to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Derived from this study: PubMed 38769727Merdler I, Case BC, Bhogal S, Reddy PK, Zhang C, Ali S, Gallino PE, Jackman C, Ben-Dor I, Satler LF, Cohen JE, Rogers T, Waksman R. Temporal trends with the Evolut family of self-expanding transcatheter heart valves: A single-center experience. Catheter Cardiovasc Interv. 2024 Jul;104(1):125-133. doi: 10.1002/ccd.31088. Epub 2024 May 20.
- Derived from this study: PubMed 35321859Medranda GA, Soria Jimenez CE, Torguson R, Case BC, Forrestal BJ, Ali SW, Shea C, Zhang C, Wang JC, Gordon P, Ehsan A, Wilson SR, Levitt R, Parikh P, Bilfinger T, Hanna N, Buchbinder M, Asch FM, Weissman G, Shults CC, Garcia-Garcia HM, Ben-Dor I, Satler LF, Waksman R, Rogers T. Lifetime management of patients with symptomatic severe aortic stenosis: a computed tomography simulation study. EuroIntervention. 2022 Aug 5;18(5):e407-e416. doi: 10.4244/EIJ-D-21-01091.
- Derived from this study: PubMed 33272031Forrestal BJ, Case BC, Yerasi C, Shea C, Torguson R, Zhang C, Ben-Dor I, Deksissa T, Ali S, Satler LF, Shults C, Weissman G, Wang JC, Khan JM, Waksman R, Rogers T. Risk of Coronary Obstruction and Feasibility of Coronary Access After Repeat Transcatheter Aortic Valve Replacement With the Self-Expanding Evolut Valve: A Computed Tomography Simulation Study. Circ Cardiovasc Interv. 2020 Dec;13(12):e009496. doi: 10.1161/CIRCINTERVENTIONS.120.009496. Epub 2020 Dec 4.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Medstar Health Research Institute at 2 sites 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Device success: (time frame: 30 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03423459, which also lists 3 linked publications.
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 26 May 2023.