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Aortic Valve StenosisNCT04639258

Medtronic Evolut™ EXPAND TAVR I Feasibility Study

A study testing Medtronic Evolut™ PRO+ System in people with Aortic Valve Stenosis, run by Medtronic Cardiovascular at 8 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
Medtronic Evolut™ PRO+ System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
8 sitesin 5 countries
Study dates
28 May 2021to 7 Jun 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm^2, or aortic valve area index ≤ 0.6 cm^2/m^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec
  • Subject denies symptoms attributable to aortic stenosis, including but not limited to:
  • Dyspnea on rest or exertion
  • Angina
  • Syncope in the absence of another identifiable cause
  • Fatigue
  • Left Ventricular Ejection Fraction (LVEF) >50%

Who cannot join

  • Age <65 years
  • Class I indication for cardiac surgery
  • Bicuspid, unicuspid, or quadricuspid aortic valve
  • In need of and suitable for coronary revascularization

Trial locations and contacts

8 sites in 5 countries.

8 sites in 5 countries

United States4 sites

  • Northwell Health

    Manhasset, New York, 11030-3816

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Los Robles Hospital & Medical Center

    Thousand Oaks, California, 91360

  • UPMC Pinnacle Harrisburg Campus

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

Australia1 site

  • The Alfred Hospital

    Melbourne

Other trials in Australia

Canada1 site

  • IUCPQ

    Québec, G1V 4G5

Other trials in Canada

Israel1 site

  • Rabin Medical Center

    Petah Tikva, 49100

Other trials in Israel

New Zealand1 site

  • Waikato Hospital

    Hamilton

Other trials in New Zealand

About this study

The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.

Read the detailed description

Single-arm, descriptive, multi-center, international

All subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.

Being tested
Medtronic Evolut™ PRO+ System
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.

  • Medtronic Evolut™ PRO+ SystemDevice

    TAVR treatment with Medtronic Evolut™ PRO+ System

Study groups in NCT04639258
Study groupRoleWhat they receive
Medtronic Evolut™ PRO+ SystemExperimentalAll study subjects will be treated with the Medtronic Evolut™ PRO+ TAVR System.
Receives: Device: Medtronic Evolut™ PRO+ System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause and Cardiovascular Mortality

    Rate of all-cause and cardiovascular mortality

    Measured: 30 days

  2. All-cause and Cardiovascular Mortality

    Rate of all-cause and cardiovascular mortality

    Measured: 6 months

  3. All Stroke (Disabling and Non-disabling)

    Rate of disabling and non-disabling stroke

    Measured: 30 days

  4. All Stroke (Disabling and Non-disabling)

    Rate of disabling and non-disabling stroke

    Measured: 6 months

  5. Myocardial Infarction (Periprocedural and Spontaneous)

    Rate of periprocedural and spontaneous myocardial infarction

    Measured: 30 days

  6. Myocardial Infarction (Periprocedural and Spontaneous)

    Rate of periprocedural and spontaneous myocardial infarction

    Measured: 6 months

  7. Acute Kidney Injury

    Rate of acute kidney injury

    Measured: 30 days

  8. Acute Kidney Injury

    Rate of acute kidney injury

    Measured: 6 months

  9. Major Vascular Complications

    Rate of major vascular complications

    Measured: 30 days

  10. Major Vascular Complications

    Rate of major vascular complications

    Measured: 6 months

  11. Life-threatening Bleed

    Rate of life-threatening (or disabling) bleed

    Measured: 30 days

  12. Life-threatening Bleed

    Rate of life-threatening (or disabling) bleed

    Measured: 6 months

  13. New Permanent Pacemaker Implantation (PPI)

    Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)

    Measured: 30 days

  14. New Permanent Pacemaker Implantation (PPI)

    Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)

    Measured: 6 months

  15. New Intraventricular Conduction Delays

    Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)

    Measured: 30 days

  16. New Intraventricular Conduction Delays

    Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)

    Measured: 6 months

  17. New-onset Atrial Fibrillation

    Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)

    Measured: 30 days

  18. New-onset Atrial Fibrillation

    Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)

    Measured: 6 months

  19. Valve-related Dysfunction Requiring Repeat Procedure

    Rate of valve-related dysfunction requiring repeat procedure

    Measured: 30 days

  20. Valve-related Dysfunction Requiring Repeat Procedure

    Rate of valve-related dysfunction requiring repeat procedure

    Measured: 6 months

  21. Device Success (VARC-2)

    The VARC-2 definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity <3 m/sec), and absence of moderate or severe prosthetic valve regurgitation

    Measured: Discharge (12 hours to 7 days post-procedure)

  22. Cardiovascular and Heart Failure Hospitalizations

    Rate of cardiovascular and heart failure hospitalizations

    Measured: 30 days

  23. Cardiovascular and Heart Failure Hospitalizations

    Rate of cardiovascular and heart failure hospitalizations

    Measured: 6 months

  24. Heart Failure Events

    Rate of heart failure events

    Measured: 30 days

  25. Heart Failure Events

    Rate of heart failure events

    Measured: 6 months

  26. Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography

    Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

    Measured: Discharge (12 hours to 7 days post-procedure)

  27. Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography

    Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

    Measured: 30 days

  28. Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography

    Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

    Measured: 6 months

  29. Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography

    Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.

    Measured: Discharge (12 hours to 7 days post-procedure)

  30. Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography

    Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.

    Measured: 30 days

  31. Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography

    Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.

    Measured: 6 months

  32. Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography

    Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography

    Measured: Discharge (12 hours to 7 days post-procedure)

  33. Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography

    Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography

    Measured: 30 days

  34. Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography

    Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography

    Measured: 6 months

  35. Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography

    Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography

    Measured: Discharge (12 hours to 7 days post-procedure)

  36. Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography

    Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography

    Measured: 30 days

  37. Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography

    Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography

    Measured: 6 months

  38. Change From Baseline in New York Heart Association (NYHA) Functional Classification

    Reporting of NYHA classification change from baseline to 30 days and 6 months

    NYHA Classification criteria:

    Class I: Subjects with cardiac disease but without resulting limitations of physical activity.

    Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.

    Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.

    Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.

    Measured: 30 days and 6 months

  39. Change From Baseline in Six-minute Walk Test (6MWT)

    Reporting change from baseline in distance walked during 6MWT

    Measured: 6 months

  40. Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

    KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

    Measured: 30 days and 6 months

  41. Change From Baseline in Left Ventricular Ejection Fraction (LVEF)

    Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography

    Measured: 6 months

  42. Change From Baseline in Global Longitudinal Strain (GLS)

    Reporting of change in GLS from baseline by echocardiography

    Measured: 6 months

  43. Change From Baseline in Left Ventricular Filling Pressure (E:e')

    Reporting of change in left ventricular filling pressure (E:e') from baseline by echocardiography

    Measured: 6 months

  44. Change From Baseline in Stroke Volume Index (SVI)

    Reporting of change in stroke volume index (SVI) from baseline by echocardiography

    Measured: 6 months

  45. Change From Baseline in NT-pro B-type Natriuretic Peptide (NT-proBNP)

    Reporting of change in NT-pro B-type natriuretic peptide (NT-proBNP) from baseline

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2020
  2. Study start28 May 2021
  3. Primary completion7 Jun 2022
  4. Study completion7 Jun 2022

Why it stopped: Reevaluation of clinical strategy in this patient population led to a business decision to discontinue the study. Discontinuation is not due to any patient safety, patient welfare, or quality issues.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04639258
Sponsor's protocol ID
D00266108
Status last verified
Jan 2024
First submitted
5 Nov 2020
Last updated
10 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Medtronic Evolut™ PRO+ System in people with Aortic Valve Stenosis, run by Medtronic Cardiovascular at 8 sites in 5 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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Australia, Canada, Israel, New Zealand. 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?

Yes. Results are posted in the registry (first posted 10 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

All-cause and Cardiovascular Mortality (time frame: 30 days). The study lists 45 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 NCT04639258.

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 10 Jan 2024.

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