The Medtronic TAVR 2.0 US Clinical Study

March 17, 2023 updated by: Medtronic Cardiovascular
The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prospective, single arm, multi-site study. Patients will be seen at pre and post procedure, discharge, 30 days, 6 months, 1 year, and annually up to 5 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale-New Haven Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Memorial Hospital
    • New York
      • New York, New York, United States, 10016
        • NYU / Langone Medical Center
      • New York, New York, United States, 10032
        • New York-Presbyterian Hospital / Columbia University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43214
        • OhioHealth Riverside Methodist Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. 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
  3. Symptoms of aortic stenosis AND New York Heart Association (NYHA) Functional Class II or greater
  4. The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.

Exclusion Criteria:

  1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve)

  2. 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
  3. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
  4. Untreated clinically significant coronary artery disease requiring revascularization
  5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography
  6. End stage renal disease requiring chronic dialysis or creatinine clearance <20 cc/min.
  7. Ongoing sepsis, including active endocarditis
  8. Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure
  9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment
  10. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
  11. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
  12. Gastrointestinal (GI) bleeding that would preclude anticoagulation
  13. Subject refuses a blood transfusion
  14. 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)
  15. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions
  16. 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-up exams
  17. Currently participating in an investigational drug or another device study (excluding registries)
  18. Evidence of an acute myocardial infarction ≤30 days before the study procedure
  19. Need for emergency surgery for any reason
  20. Liver failure (Child-Pugh class C)
  21. Subject is pregnant or breast feeding
  22. Pre existing prosthetic heart valve in any position
  23. Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation)
  24. Severe mitral regurgitation
  25. Severe tricuspid regurgitation
  26. Moderate or severe mitral stenosis
  27. Hypertrophic obstructive cardiomyopathy
  28. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation
  29. Congenital bicuspid or unicuspid valve verified by echocardiography
  30. Access vessel diameter <5.5 mm or <6.0 mm for patent left internal mammary artery (LIMA)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Medtronic Transcatheter Aortic Valve 2.0 Replacement System
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Device: Medtronic Transcatheter Aortic Valve 2.0 Replacement System
Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
All-cause Mortality Rate
Time Frame: 30 days
30 days
Stroke (Disabling) Rate
Time Frame: 30 days
30 days
The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram
Time Frame: 30 days
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:
Time Frame: 30 days

  1. All-cause mortality

    >

  2. All stroke (disabling and non-disabling)

    >

  3. Life-threatening bleeding

    >

  4. Acute kidney injury: stage 2 or 3 (including renal replacement therapy)

    >

  5. Coronary artery obstruction requiring intervention

    >

  6. Major vascular complication

    >

  7. Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)
30 days
Percentage of Participants With Life Threatening or Disabling Bleeding
Time Frame: 30 days
Percentage of participants with life threatening or disabling bleeding - VARC-II definitions
30 days
Percentage of Participants With Major Vascular Complication
Time Frame: 30 days
Percentage of participants with major vascular complication - VARC-II definition
30 days
Percentage of Participants With Coronary Artery Obstruction
Time Frame: 30 days
Percentage of participants with coronary artery obstruction - VARC-II definitions
30 days
Percentage of Patient With Acute Kidney Injury- Stage 2 or 3
Time Frame: 30 days
Percentage of participants with Acute kidney injury - Stage 2 or 3 - VARC-II definitions
30 days
Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure
Time Frame: 30 days
Percentage of participants with valve-related dysfunction requiring repeat procedure - VARC-II definition
30 days
Device Success Rate (VARC II)
Time Frame: 24 hours to 7 days
24 hours to 7 days
Hemodynamic Performance - Aortic Valve Area
Time Frame: 30 days
Aortic Valve Area (cm2) by transthoracic echocardiogram
30 days
Hemodynamic Performance - Mean Gradient
Time Frame: 30 days
Mean gradient (mmHg) by transthoracic echocardiogram
30 days
Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace
Time Frame: 30 days
Total prosthetic regurgitation by transthoracic echocardiogram
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiovascular

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Forrest, MD, Yale New Haven Hospital
  • Principal Investigator: Mathew Williams, MD, NYU Langone Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10233065DOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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