Aortic Valve StenosisNCT02746809
Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum)
A study testing CoreValve Evolut 34R TAVR system in people with Aortic Valve Stenosis, run by Medtronic Cardiovascular at 10 sites in United States.
Trial summary
The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme risk for surgical aortic valve replacement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- CoreValve Evolut 34R TAVR system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 10 sitesUnited States
- Study dates
- Jun 2016to 15 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Severe aortic stenosis, defined as aortic valve area of < 1.0 cm2 (or aortic valve area index of < 0.6 cm2/m2) by the continuity equation, AND mean gradient > 40 mmHg or maximal aortic valve velocity > 4.0 m/sec by resting echocardiogram.
- Subjects with low-flow/low gradient severe aortic stenosis can be included, provided low-dose dobutamine or exercise stress echocardiography demonstrates a mean gradient of > 40 mmHg or a maximal aortic valve velocity of > 4.0 m/sec, AND aortic valve area of < 1.0 cm2 (or aortic valve area index of < 0.6 cm2/m2).
- Society of Thoracic Surgeons (STS) score of ≥ 8 OR documented heart team agreement of ≥ high risk for aortic valve replacement due to frailty or co-morbidities.
- Symptoms of aortic stenosis, AND New York Heart Association (NYHA) Functional Class II or greater.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Who cannot join
- Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).
- A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
- aspirin or heparin (HIT/HITTS) and bivalirudin
- ticlopidine and clopidogrel
- Nitinol (titanium or nickel)
- contrast media
Show all 36Show fewer
- Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
- End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
- Ongoing sepsis, including active endocarditis.
- Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure.
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
- Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
- Gastrointestinal (GI) bleeding that would preclude anticoagulation.
- Subject refuses a blood transfusion.
- Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
- Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.
- Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-ups exams.
- Currently participating in an investigational drug or another device study (excluding registries).
- Evidence of an acute myocardial infarction ≤ 30 days before the study procedure.
- Need for emergency surgery for any reason.
- Liver failure (Child-Pugh class C).
- Subject is pregnant or breast feeding.
- Anatomical exclusion criteria:
- Pre-existing prosthetic heart valve in any position.
- Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation).
- Severe mitral regurgitation.
- Severe tricuspid regurgitation.
- Moderate or severe mitral stenosis.
- Hypertrophic obstructive cardiomyopathy.
- Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation.
- Congenital bicuspid or unicuspid valve verified by echocardiography.
- For transfemoral or transaxillary (subclavian) access:
- Access vessel diameter < 5.5 mm or <6.0 mm for patent left internal mammary artery (LIMA)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Michigan Health Systems
Ann Arbor, Michigan, 48109
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Riverside Methodist Hospital
Columbus, Ohio, 43214
Baylor Heart and Vascular Hospital
Dallas, Texas, 75225
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503
Pinnacle Health/Moffitt Heart and Vascular Institute
Harrisburg, Pennsylvania, 17104
Aurora Health Care/St Luke's Medical Center
Milwaukee, Wisconsin, 53215
Yale New Haven Hospital
New Haven, Connecticut, 06520
New York Langone Medical Center
New York, New York, 10016
St. Francis Hospital
Roslyn, New York, 11576
About this study
Official title: Medtronic CoreValve Evolut R United States Clinical Study (Evolut 34R Addendum)
The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme risk for surgical aortic valve replacement.
Read the detailed description
This objective will be accomplished by a prospective, single arm, historical controlled, multi-site study involving up to 60 implanted subjects at up to 15 study sites in the United States. Procedural and 30 day safety and efficacy results from this study will be compared to appropriate historical control data for the Medtronic CoreValve System. Subjects will be followed up to 5 years following implantation.
- Conditions
- Aortic Valve Stenosis
- Being tested
- CoreValve Evolut 34R TAVR 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.
CoreValve Evolut 34R TAVR systemDevice
The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
- Evolut 34R Transcatheter Aortic Valve (TAV)
- EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
- EnVeo R Loading System (LS)
| Study group | Role | What they receive |
|---|---|---|
| CoreValve Evolut 34R TAVR system | Experimental | Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System. Receives: Device: CoreValve Evolut 34R TAVR system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With All-cause Mortality
Percentage of participants with all-cause mortality at 30 days
Measured: 30 Days
Percentage of Participants With Stroke (Disabling)
Percentage of participants with disabling stroke (VARC-II definitions) at 30 days
Measured: 30 Days
Device Success Rate
Device Success 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 the absence of patient prosthesis-mismatch and mean gradient < 20 mmHg (or peak velocity < 3 m/sec), AND
- Absence of moderate or severe prosthetic valve regurgitation
Measured: 24 hours to 7 days post implantation
The Percentage of Subjects With no More Than Mild Prosthetic Regurgitation at Early Post Procedure Echocardiogram
The percentage of subjects with no more than mild prosthetic regurgitation at early post procedure echocardiogram as assessed by echo core laboratory
Measured: 24 hours to 7 days post implantation
Secondary outcomes (11)
Percentage of Participants With VARC II Combined Safety Endpoint Event at 30 Days
VARC II composite safety endpoint includes the following components:
- All-cause mortality
- All stroke (disabling and non-disabling)
- Life-threatening bleeding
- Acute kidney injury: stage 2 or 3 (including renal replacement therapy).
- Coronary artery obstruction requiring intervention.
- Major vascular complication.
- Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)
Measured: 30 days post-implantation
Percentage of Participants With Life Threatening or Disabling Bleeding
Percentage of participants with life threatening or disabling bleeding - see VARC-2 definitions for classification details
Measured: 30 days post-implantation
Percentage of Participants With Major Vascular Complication
Percentage of participants with Major vascular complication - see VARC-2 definitions for additional details
Measured: 30 days
Percentage of Participants With Acute Kidney Injury: Stage 2 or 3
Percentage of participants with Acute Kidney Injury: Stage 2 or 3 - see VARC-2 definitions for additional details
Measured: 30 days
Percentage of Participants With Coronary Artery Obstruction
Percentage of participants with coronary artery obstruction - see VARC-2 definitions for additional details
Measured: 30 days
Percentage of Subjects With Valve-related Dysfunction Requiring Repeat Procedure
Percentage of subjects with valve-related dysfunction requiring repeat procedure - see VARC-2 definitions for additional details
Measured: 30 days
Percentage of Subjects With Permanent Pacemaker Implant at 30 Days
Percentage of subjects with new permanent pacemaker implant at 30 days.
Measured: 30 days
Percentage of Resheath and Recapture Success
Successful resheathing is defined as Evolut R TAV (including frame) was resheathed into the capsule of the delivery cathether to the desired amount intended, as verified by fluoroscopy.
Successful recapture is defined as the entire Evolut R TAV (including frame) is resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip, as verified by fluoroscopy.
Measured: Implant procedure
Hemodynamic Performance Metrics - Mean Gradient
Mean gradient (mmHg) as measured by transthoracic echocardiogram and assessed by echo core laboratory
Measured: 30 days
Hemodynamic Performance Metrics- Aortic Valve Area
Aortic valve area as measured by transthoracic echocardiogram and assessed by echo core laboratory
Measured: 30 Days
Hemodynamic Performance Metrics - Total Prosthetic Regurgitation Graded as None/Trace
Total prosthetic regurgitation (none/trace) as measured by transthoracic echocardiogram and assessed by echo core laboratory
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 posted21 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mathew R Williams, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746809
- Sponsor's protocol ID
- 10211838DOC
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2016
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtronic CoreValve Evolut R United States Clinical Study (Evolut 34R Addendum)
- ClinicalTrials.gov ID
- NCT02746809
- Acronym / sponsor ID
- 10211838DOC
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Posted 29 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme risk for surgical aortic valve replacement.
Detailed description
This objective will be accomplished by a prospective, single arm, historical controlled, multi-site study involving up to 60 implanted subjects at up to 15 study sites in the United States. Procedural and 30 day safety and efficacy results from this study will be compared to appropriate historical control data for the Medtronic CoreValve System. Subjects will be followed up to 5 years following implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoreValve Evolut 34R TAVR system | Experimental | Device: CoreValve Evolut 34R TAVR systemTreatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Severe aortic stenosis, defined as aortic valve area of < 1.0 cm2 (or aortic valve area index of < 0.6 cm2/m2) by the continuity equation, AND mean gradient > 40 mmHg or maximal aortic valve velocity > 4.0 m/sec by resting echocardiogram.
- Subjects with low-flow/low gradient severe aortic stenosis can be included, provided low-dose dobutamine or exercise stress echocardiography demonstrates a mean gradient of > 40 mmHg or a maximal aortic valve velocity of > 4.0 m/sec, AND aortic valve area of < 1.0 cm2 (or aortic valve area index of < 0.6 cm2/m2).
- Society of Thoracic Surgeons (STS) score of ≥ 8 OR documented heart team agreement of ≥ high risk for aortic valve replacement due to frailty or co-morbidities.
- Symptoms of aortic stenosis, AND New York Heart Association (NYHA) Functional Class II or greater.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Key exclusion criteria (36 listed)
- Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).
- A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
- Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
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 |
|---|---|---|
| CoreValve Evolut 34R TAVR systemThe CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components: 1. Evolut 34R Transcatheter Aortic Valve (TAV) 2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath 3. EnVeo R Loading System (LS) | Device | CoreValve Evolut 34R TAVR system |
Primary outcome
Percentage of Participants With All-cause Mortality
Time frame: 30 Days
Percentage of participants with all-cause mortality at 30 days
Percentage of Participants With Stroke (Disabling)
Time frame: 30 Days
Percentage of participants with disabling stroke (VARC-II definitions) at 30 days
Device Success Rate
Time frame: 24 hours to 7 days post implantation
Device Success 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 the absence of patient prosthesis-mismatch and mean gradient < 20 mmHg (or peak velocity < 3 m/sec), AND * Absence of moderate or severe prosthetic valve regurgitation
The Percentage of Subjects With no More Than Mild Prosthetic Regurgitation at Early Post Procedure Echocardiogram
Time frame: 24 hours to 7 days post implantation
The percentage of subjects with no more than mild prosthetic regurgitation at early post procedure echocardiogram as assessed by echo core laboratory
11 secondary outcomes
Percentage of Participants With VARC II Combined Safety Endpoint Event at 30 Days
Time frame: 30 days post-implantation
Percentage of Participants With Life Threatening or Disabling Bleeding
Time frame: 30 days post-implantation
Percentage of Participants With Major Vascular Complication
Time frame: 30 days
Percentage of Participants With Acute Kidney Injury: Stage 2 or 3
Time frame: 30 days
Percentage of Participants With Coronary Artery Obstruction
Time frame: 30 days
Percentage of Subjects With Valve-related Dysfunction Requiring Repeat Procedure
Time frame: 30 days
Percentage of Subjects With Permanent Pacemaker Implant at 30 Days
Time frame: 30 days
Percentage of Resheath and Recapture Success
Time frame: Implant procedure
Hemodynamic Performance Metrics - Mean Gradient
Time frame: 30 days
Hemodynamic Performance Metrics- Aortic Valve Area
Time frame: 30 Days
Hemodynamic Performance Metrics - Total Prosthetic Regurgitation Graded as None/Trace
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Mathew R Williams, MD principal investigator
NYU Langone Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoreValve Evolut 34R TAVR system in people with Aortic Valve Stenosis, run by Medtronic Cardiovascular at 10 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 5 inclusion and 36 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 3 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 10 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?
Yes. Results are posted in the registry (first posted 29 Dec 2017). 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?
Percentage of Participants With All-cause Mortality (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 3 May 2023.