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Aortic StenosisNCT02207569

Medtronic CoreValve Evolut R U.S. Clinical Study

A study testing CoreValve Evolut R TAVR system in people with Aortic Stenosis, run by Medtronic Cardiovascular at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis 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 Stenosis
What is being tested?
CoreValve Evolut R TAVR system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
23 sitesUnited States
Study dates
Aug 2014to 28 Oct 2020
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

None listed.

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
  • 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.
Show all 32Show fewer
  • 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 the 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) acess:
  • Access vessel diameter <5.0mm or <6.0mm for patent LIMA

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • University of Michigan Health Systems

    Ann Arbor, Michigan, 48109

  • The Johns Hopkins University

    Baltimore, Maryland, 21287

  • Beth Israel Deaconcess Medical Center

    Boston, Massachusetts, 02215

  • Riverside Methodist Hospital/Ohio Health Research Institute

    Columbus, Ohio, 43214

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75225

  • Detroit Medical Center Cardiovascular Institute

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • The Methodist DeBakey Heart & Vasc Ctr/The Methodist Hosp

    Houston, Texas, 77030

  • St. Vincent Heart Center of Indiana/The Care Group, LLC

    Indianapolis, Indiana, 46290

  • University of Kansas

    Kansas City, Kansas, 66160

  • University of Southern California

    Los Angeles, California, 90033

  • Aurora Health Care/St Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

  • New York Langone Medical Center

    New York, New York, 10016

  • The Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • University of Pittsburg Medical Center

    Pittsburgh, Pennsylvania, 15213

  • St. Francis Hospital

    Roslyn, New York, 11576

  • Washington Hospital Center/Medstar

    Washington D.C., District of Columbia, 20010

  • Pinnacle Health

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

About this study

Official title: Medtronic CoreValve Evolut R United States IDE Clinical Study

The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis 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 a minimum of 150 implanted subjects with no more than 250 implanted subjects at up to 25 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.

The enrollment phase of the study is estimated to take approximately 6-9 months. As each implanted subject is to be followed up to 5 years, the estimated study duration is approximately 66-69 months, excluding the time required for preparing the final report.

Conditions
Aortic Stenosis
Being tested
CoreValve Evolut R 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 R TAVR systemDevice

Study groups in NCT02207569
Study groupRoleWhat they receive
CoreValve Evolut R TAVR systemExperimentalThe CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components: 1. Evolut R Transcatheter Aortic Valve (TAV) 2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath 3. EnVeo R Loading System (LS)
Receives: Device: CoreValve Evolut R TAVR system

What is being measured

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

  1. All-cause Mortality at 30 Days by Percent

    Percentage of patients that died by any cause at 30 days

    Measured: Assessed at 30 days post-implantation

  2. Percentage of Patients With Disabling Stroke at 30 Days

    Stroke Diagnostic Criteria:

    >

    Acute episode of focal or global neurological deficit with at least 2 of the following:

    • change in level of consciousness >
    • hemiplegia, hemiparesis
    • numbness or sensory loss affecting 1 side >
    • dysphasia or aphasia
    • hemianopia
    • amaurosis fugax >
    • other neurological signs or symptoms consistent with stroke 2.) No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist 3.) Confirmation of the diagnosis by at least 1 of the following:
    • Neurological specialist >
    • Neuroimaging procedure, or on clincial grounds alone > Stroke: durations of neural deficit > 24 h if available neuroimaging documents a new hemofrrhage or infarct; or the neurological deficit results in death

    Defined by VARC II:

    > An mRS (Modified Rankin Score) of 2 or more at 90 days and an increase in at least 1 mRS category from pre-stroke baseline

    Measured: Assessed at 30 days post-implantation

  3. Percent Device Success Rate Between 24 and 7 Day

    Percentage of patients with Device Success defined as:

    • Absence of procedural mortality, AND
    • Correct positioning of a single Evolut R valve into the proper anatomical location, AND
    • Absence of patient-prosthesis mismatch, and mean gradient , 20 mm Hg (or peak velocity < 3m/sec, AND
    • Absence of moderate or severe prosthetic valve regurgitation

    Measured: Assessed at 24 hours to seven days post implantation

  4. Percentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days)

    Percentage of patience with none, trace or mild total prosthetic regurgitation at early post procedure echo cardiogram (24 hours to 7 days) as evaluated by echo core lab.

    Measured: Assessed at 24 hours to 7 days post implantation

Secondary outcomes (11)

  1. Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR)

    Percentage of patients with any valve dysfunction that requires repeat procedure (e.g. balloon valvuloplasty, TAVI, or surgical AVR), per VARC II definition.

    Measured: Assessed at 30 days post-implantation

  2. Coronary Artery Obstruction Requiring Intervention.

    Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the Evolut R prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure.

    Measured: Assessed at 30 days post-implantation

  3. Percent VARC II Combined Safety Endpoint at 30 Days

    VARC II composite safety endpoint rate includes percent freedom from 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, TAVI, or SAVR)

    Measured: Assessed at 30 days post-implantation

  4. Percent of Patients With Acute Kidney Injury: Stage 2 or 3 (Including Renal Replacement Therapy).

    Stage 2

    1. Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR >
    2. Urine output <0.5 mL/kg/h for >12 but <24 h > Stage 3 >
    3. Increase in serum creatinine to ≥300% (>3 x increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR
    • Urine output <0.3 ml/kg/h for ≥24 h OR >
    • Anuria for ≥12 h

    Measured: Assessed at 30 days post-implantation

  5. Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate

    1. Fatal bleeding (BARC type 5) OR >
    2. Bleeding in a critical organs, such as intracranial, intraspinal, > intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR >
    3. Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR >
    4. Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* > (BARC type 3b)

    Measured: Assessed at 30 days post-implantation

  6. Percent Rate of Patients Who Received New Permanent Pacemaker Implant at 30 Days

    Percent of patients who underwent implantation of new permanent pacemaker or ICD during or after index procedure

    Measured: Assessed at 30 days

  7. Percent Resheath and Recapture Success Rate

    Resheath or recapture success rate (where attempted) where a successful resheath is defined as the intended portion of the Evolut R is resheathed into the capsule of the delivery catheter to the intended amount, as verified by flouroscopy; and a successful recapture is defined as the entire Evolut R TAV (including the frame) is full resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip , as verified by flouroscopy. Resheath or recapture wa attempted in a subset of patients. Success rate is calculated as successful resheath or recaputure events in the number of total events. Resheath anad recapture is only possible during the index procedure.

    Measured: Assessed intra-procedurally

  8. Hemodynamic Performance -Mean Gradient

    Mean gradient by Doppler echocardiography.

    Measured: Assessed at baseline, 30 days, 6 months, and 1 year

  9. Major Vascular Complication

    1. Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR >
    2. Access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment OR >
    3. Distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR >
    4. The use of unplanned endovascular or surgery associated with death, major bleeding, visceral ischemia or neurological impairment OR >
    5. Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR >
    6. Surgery for access site nerve injury OR >
    7. Permanent access related nerve injury

    Measured: Assessed at 30 days post-implantation

  10. Hemodynamic Performance - Aortic Valve Area

    Hemodynamic performance by Doppler echocardiography - Aortic Valve Area cm2

    Measured: Assessed at baseline, 30 days, 6 months, and 1 year

  11. Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe

    Hemodynamic performance: the percent of patients who have a degree of total prosthetic valve regurgitation that is moderate or severe.

    Measured: Assessed at 30 days, 6 months, and 1 year

Timeline

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

  1. First posted4 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionAug 2015
  4. Study completion28 Oct 2020

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
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02207569
Sponsor's protocol ID
10126779DOC
Status last verified
Oct 2022
First submitted
24 Jul 2014
Last updated
2 Nov 2022
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Popma JJ, Reardon MJ, Khabbaz K, Harrison JK, Hughes GC, Kodali S, George I, Deeb GM, Chetcuti S, Kipperman R, Brown J, Qiao H, Slater J, Williams MR. Early Clinical Outcomes After Transcatheter Aortic Valve Replacement Using a Novel Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Who Are Suboptimal for Surgery: Results of the Evolut R U.S. Study. JACC Cardiovasc Interv. 2017 Feb 13;10(3):268-275. doi: 10.1016/j.jcin.2016.08.050.

    PubMed 28183466

Questions about this trial

What is this clinical trial studying?

A study testing CoreValve Evolut R TAVR system in people with Aortic Stenosis, run by Medtronic Cardiovascular at 23 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 0 inclusion and 32 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 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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 12 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?

All-cause Mortality at 30 Days by Percent (time frame: Assessed at 30 days post-implantation). 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?

On the ClinicalTrials.gov record for NCT02207569, which also lists 1 linked publication.

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 2 Nov 2022.

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