Aortic Valve StenosisNCT02738853
The Medtronic TAVR 2.0 US Clinical Study
A study testing Medtronic Transcatheter Aortic Valve 2.0 Replacement System in people with Aortic Valve Stenosis, run by Medtronic Cardiovascular at 8 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Medtronic Transcatheter Aortic Valve 2.0 Replacement System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 2016to 15 Dec 2021
- 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 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
- 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 (eg, 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
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- 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-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
- Need for emergency surgery for any reason
- Liver failure (Child-Pugh class C)
- Subject is pregnant or breast feeding
- 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
- Access vessel diameter <5.5 mm or <6.0 mm for patent left internal mammary artery (LIMA)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
Houston Methodist Hospital
Houston, Texas, 77030
The University of Kansas Hospital
Kansas City, Kansas, 66160
Morristown Memorial Hospital
Morristown, New Jersey, 07960
Yale-New Haven Hospital
New Haven, Connecticut, 06520
NYU / Langone Medical Center
New York, New York, 10016
New York-Presbyterian Hospital / Columbia University Medical Center
New York, New York, 10032
About this study
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
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Medtronic Transcatheter Aortic Valve 2.0 Replacement 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 Transcatheter Aortic Valve 2.0 Replacement SystemDevice
Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
| Study group | Role | What they receive |
|---|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System | Experimental | Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System Receives: Device: Medtronic Transcatheter Aortic Valve 2.0 Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality Rate
Measured: 30 days
Stroke (Disabling) Rate
Measured: 30 days
The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram
Measured: 30 days
Secondary outcomes (10)
Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which 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
Percentage of Participants With Life Threatening or Disabling Bleeding
Percentage of participants with life threatening or disabling bleeding - VARC-II definitions
Measured: 30 days
Percentage of Participants With Major Vascular Complication
Percentage of participants with major vascular complication - VARC-II definition
Measured: 30 days
Percentage of Participants With Coronary Artery Obstruction
Percentage of participants with coronary artery obstruction - VARC-II definitions
Measured: 30 days
Percentage of Patient With Acute Kidney Injury- Stage 2 or 3
Percentage of participants with Acute kidney injury - Stage 2 or 3 - VARC-II definitions
Measured: 30 days
Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure
Percentage of participants with valve-related dysfunction requiring repeat procedure - VARC-II definition
Measured: 30 days
Device Success Rate (VARC II)
Measured: 24 hours to 7 days
Hemodynamic Performance - Aortic Valve Area
Aortic Valve Area (cm2) by transthoracic echocardiogram
Measured: 30 days
Hemodynamic Performance - Mean Gradient
Mean gradient (mmHg) by transthoracic echocardiogram
Measured: 30 days
Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace
Total prosthetic regurgitation by transthoracic echocardiogram
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 posted14 Apr 2016 (estimated)
- Study startApr 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Forrest, MD, Principal investigator, Yale New Haven HospitalMathew Williams, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738853
- Sponsor's protocol ID
- 10233065DOC
- Status last verified
- Mar 2023
- First submitted
- 11 Apr 2016
- Last updated
- 21 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wyler von Ballmoos MC, Reardon MJ, Williams MR, Mangi AA, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Oh JK, Qiao H, Forrest JK. Three-Year Outcomes With a Contemporary Self-Expanding Transcatheter Valve From the Evolut PRO US Clinical Study. Cardiovasc Revasc Med. 2021 May;26:12-16. doi: 10.1016/j.carrev.2020.11.007. Epub 2020 Nov 10.
PubMed 33199247Forrest JK, Mangi AA, Popma JJ, Khabbaz K, Reardon MJ, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Saul S, Qiao H, Oh JK, Williams MR. Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap. JACC Cardiovasc Interv. 2018 Jan 22;11(2):160-168. doi: 10.1016/j.jcin.2017.10.014.
PubMed 29348010