Bicuspid Aortic ValveNCT03635424
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
A study testing Medtronic TAVR Systems in people with Bicuspid Aortic Valve, run by Medtronic Cardiovascular at 25 sites in United States.
Trial summary
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Bicuspid Aortic Valve
- What is being tested?
- Medtronic TAVR Systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 25 sitesUnited States
- Study dates
- 30 Oct 2018to Dec 2030
- Phase
- Interventional
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe aortic stenosis, defined as follows:
- For symptomatic patients:
- Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest
- For asymptomatic patients:
- Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR
- Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR
Show all 10Show fewer
- Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%.
- Patient is considered low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart team assessment.
- Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT.
- 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 (eg, subject is indicated for mechanical prosthetic valve).
- Age less than 60 years
- A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:
- aspirin or heparin (HIT/HITTS) and bivalirudin
- ticlopidine and clopidogrel
- Nitinol (titanium or nickel)
Show all 37Show fewer
- 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.
- Ongoing sepsis, including active endocarditis.
- Any percutaneous coronary or peripheral interventional procedure with a bare metal stent or drug eluting stent performed within 30 days prior to screening committee approval.
- Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery.
- 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 2 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 24 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-up 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 due to unstable coronary artery disease (WHO criteria).
- Need for emergency surgery for any reason.
- Subject is pregnant or breast feeding.
- Subject is legally incompetent, or otherwise vulnerable
- Anatomical exclusion criteria:
- Pre-existing prosthetic heart valve in any position.
- Severe mitral regurgitation amenable to surgical replacement or repair.
- Severe tricuspid regurgitation amenable to surgical replacement or repair.
- Moderate or severe mitral stenosis amenable to surgical replacement or repair.
- Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
- Prohibitive left ventricular outflow tract calcification.
- Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis
- Aortic annulus diameter of <18 or >30 mm.
- Significant ascending aortopathy requiring surgical repair
- Ascending aorta diameter > 4.5 cm
- For transfemoral or transaxillary (subclavian) access:
- Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <5.5 mm for Evolut 34R mm or Evolut PRO 23R, 26R, 29 R mm TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <6.0 mm for the Evolut 34R or Evolut PRO TAV.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Morton Plant Hospital
Clearwater, Florida, 33756
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
Baylor Jack and Jane Hamilton Heart & Vascular Hospital
Dallas, Texas, 75226
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
HealthPark Medical Center
Fort Myers, Florida, 33908
Spectrum Health Hospital
Grand Rapids, Michigan, 49503
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, 17101
Houston Methodist Hospital
Houston, Texas, 77030
Scripps Memorial Hospital La Jolla
La Jolla, California, 92037
North Shore University Hospital
Manhasset, New York, 11030
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Yale New Haven Hospital
New Haven, Connecticut, 06510
The Mount Sinai Hospital
New York, New York, 10029
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85016
Oregon Health & Science University Hospital
Portland, Oregon, 97239
Saint Francis Hospital
Roslyn, New York, 11576
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
Paramount Heart
Villanova, Pennsylvania, 19085
About this study
Official title: Transcatheter Aortic Valve Replacement (TAVR) With Medtronic TAVR System in Patients With Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality With Surgical Aortic Valve Replacement (SAVR)
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
Read the detailed description
Multi-center, prospective, single arm
All subjects will be treated with a Medtronic TAVR system. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 1 year, and annually through 10 years
- Conditions
- Bicuspid Aortic Valve
- Being tested
- Medtronic TAVR Systems
- Medical subject headings
- Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic TAVR SystemsDevice
Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems
| Study group | Role | What they receive |
|---|---|---|
| Medtronic TAVR Systems | Experimental | Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems Receives: Device: Medtronic TAVR Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure.
Rate of of all-cause mortality or disabling stroke rate at 30 days
Measured: 30 days
Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure.
Device success rate, defined as:
- Absence of procedural mortality, AND
- Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND
- Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)
Measured: 7 days
Secondary outcomes (18)
All-Cause Mortality Rate
Rate of all cause mortality
Measured: 1 year and annually through 10 years
All Stroke (Disabling and Non-Disabling) Rate
Rate of disabling and non-disabling strokes
Measured: 1 year and annually through 10 years
Percent of Participants With New Permanent Pacemaker Implantation at 30 Days Post-procedure.
Rate of new permanent pacemaker implantation at 30 days post-procedure (excludes patients with pre-existing pacemaker at baseline)
Measured: 30 days
Percent of Participants Who Experience a Myocardial Infarction at 30 Days Post-procedure.
The rate of myocardial infarction at 30 days
Measured: 30 days
Percent of Participants With a Life-Threatening Bleeding Event at 30 Days Post-procedure.
Rate of life-threatening (or disabling) bleeding at 30 days
Measured: 30 days
Percent of Participants With Prosthetic Valve Endocarditis at 30 Days Post-procedure.
Rate of prosthetic valve endocarditis at 30 days
Measured: 30 days
Percent of Participant With Prosthetic Valve Thrombosis at 30 Days Post-procedure.
Rate of prosthetic valve thrombosis at 30 days
Measured: 30 days
Percent pf Participants With Valve-Related Dysfunction Requiring Repeat Procedure at 30 Days Post-procedure.
Rate of valve-related dysfunction requiring repeat procedure at 30 days
Measured: 30 days
Percent of Participants With a Repeat Hospitalization for Aortic Valve Disease at 30 Days Post-procedure.
Rate of repeat hospitalization for aortic valve disease at 30 days
Measured: 30 days
Percent of Participants With a Repeat Hospitalization for Ascending Aorta Disease at 30 Days Post-procedure.
Rate of repeat hospitalization for ascending aorta disease at 30 days
Measured: 30 days
Hemodynamic Performance Metrics by Doppler Echocardiography: Mean Aortic Gradient Reported as Mean Average at Baseline and 30 Days
Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
Measured: 30 days
Hemodynamic Performance Metrics by Doppler Echocardiography: Effective Orifice Area Reported as Mean Average at Baseline and 30 Days.
Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.
Measured: 30 days
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days
Reporting of prosthetic valve hemodynamic performance by degree of total prosthetic valve regurgitation at 30 days post-procedure
Measured: 30 days
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Paravalvular Prosthetic Regurgitation at 30 Days
Reporting of prosthetic valve hemodynamic performance by degree of paravalvular regurgitation at 30 days post-procedure
Measured: 30 days
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Transvalvular Prosthetic Regurgitation at 30 Days
Reporting of prosthetic valve hemodynamic performance by degree of transvalvular regurgitation at 30 days post-procedure
Measured: 30 days
New York Heart Association (NYHA) Functional Classification at Baseline and 30 Days
Reporting of NYHA classification change from baseline to 30 days
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
Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days
QoL overall summary (all domains below) and clinical summary (physical function and symptoms only) scores and change in summary scores from baseline using the following measures:
- KCCQ: Quantifies physical function, symptoms, social function, self-efficacy and 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
Health-related Quality of Life (QoL) as Assessed by European QoL (EQ-5D) at Baseline and 30 Days.
QoL summary scores and change from baseline using the following measures:
- EQ-5D: Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state
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 posted17 Aug 2018
- Study start30 Oct 2018
- Primary completion13 Nov 2019
- Study completionDec 2030 (estimated)
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bicuspid Aortic ValveStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Reardon, MD, Study chair, The Methodist Hospital Research InstituteJohn Forrest, MD, Principal investigator, Yale UniversityBasel Ramlawi, MD, Principal investigator, Paramount Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635424
- Sponsor's protocol ID
- 10790330DOC
- Status last verified
- Apr 2026
- First submitted
- 31 Jul 2018
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Forrest JK, Ramlawi B, Deeb GM, Zahr F, Song HK, Kleiman NS, Chetcuti SJ, Michelena HI, Mangi AA, Skiles JA, Huang J, Popma JJ, Reardon MJ. Transcatheter Aortic Valve Replacement in Low-risk Patients With Bicuspid Aortic Valve Stenosis. JAMA Cardiol. 2021 Jan 1;6(1):50-57. doi: 10.1001/jamacardio.2020.4738.
PubMed 33031491