This group included 747 patients at 45 hospitals in the United States.

The Evolut R CE Mark Clinical Study is a prospective, multicenter, controlled, nonrandomized single-arm clinical study to evaluate the repositionable Evolut R system in patients with symptomatic aortic stenosis and heart-team assessed risk of operative mortality.

84% of patients received CoreValve and 16% received Evolut R. 93% of patients received Evolut R and 7% received CoreValve. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.

Talk with your doctor and family members or friends about deciding to join a study. Update my browser now. The CoreValve procedure had an acceptable safety profile and was an effective alternative. TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), LIFELINE CARDIOVASCULAR TECHNICAL SUPPORT, Electromagnetic Compatibility Guide for Cardiac Devices, Minimally Invasive Therapies (formerly Covidien), Information About Proposition 65 for California Customers, California Transparency in Supply Chains Act. If you are interested, ask your doctor for more information on additional clinical studies. and were effective in treating severe aortic stenosis patients at intermediate risk. Clinical trials of transcatheter aortic valve replacement Karim Al-Azizi, Mohanad Hamandi, Michael Mack Review ... (Medtronic, Inc, Minneapolis, MN).

Therapies & Procedures This site uses cookies to store information on your computer.



Patients underwent attempted TAV implant under the same inclusion and exclusion criteria and trial procedures as the SURTAVI Trial, with no randomization to surgery.†. The purpose of this study was to evaluate the safety and effectiveness of the CoreValve system in a subset of subjects excluded from the U.S.

The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year, 18 months, and annually through 10 years. The trial included 1,660 patients at 87 hospitals in the United States, Europe, and Canada. Primary safety endpoints were all cause mortality and disabling stroke at 30 days, and the primary efficacy endpoint was percentage of patients with no or trace aortic regurgitation at 30 days.

These patients were at Intermediate Risk for surgery.

The trial showed similar results to the PARTNER 2A trial, and showed that TAVR was

By using the site, you consent to the placement of these cookies. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.

Treatments & Therapies A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated: Subject is legally incompetent, or otherwise vulnerable. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT.

Some are essential to make our site work; others help us improve the user experience. About Compendium. One hundred fifty (150) received the heart valve through a space between their ribs or an artery in their neck. Most received the CoreValve heart valve through an artery in their leg. A bioprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve.



Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

The SURTAVI Trial is a prospective, randomized, multicenter, noninferiority study to compare the safety and efficacy of the Medtronic TAVR system* to SAVR in patients with symptomatic severe aortic stenosis at intermediate surgical risk. Severe aortic stenosis, defined as follows: 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, 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. Studies below are organized by product name and link to a downloadable presentation or study PDF. Your doctor will let you know which risks most likely apply to you based on the patient groups below. These patients were too sick for surgery. The FORWARD Study is a prospective, single-arm, multicenter, observational study to assess the safety and clinical performance of the Medtronic Evolut R system in patients with symptomatic native aortic stenosis or failed bioprosthesis in routine practice.

The CoreValve and Evolut R heart valves were found to have an acceptable safety profile. VIVA is a prospective, observational, single-arm, post-market, multicenter study to collect data regarding use of TAVR with the CoreValve and Evolut R devices in patients with failing surgical aortic bioprostheses at high risk for re-do open-heart surgery. to other options — medications or balloon valvuloplasty.

This group included 151 patients at 24 hospitals in the United States, Australia, New Zealand, and the UK. Severe tricuspid regurgitation amenable to surgical replacement or repair. Transcatheter aortic valve replacement (TAVR - also known as TAVI or transcatheter aortic valve implantation) is a new technology for use in treating aortic stenosis. Genetic and Rare Diseases Information Center, 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

Gastrointestinal (GI) bleeding that would preclude anticoagulation. Change in health-related quality of life assessed by Kansas City Cardiomyopathy, Change in health-related quality of life as assessed by EQ-5D survey. Currently participating in an investigational drug or another device study (excluding registries). Choosing to participate in a study is an important personal decision.

Transcatheter Aortic Valve Replacement in Low-risk Patients With Bicuspid Aortic Valve Stenosis. The STS PROM range in this trial was 3–15%.

Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve). Ongoing sepsis, including active endocarditis. The CoreValve procedure had an acceptable safety profile and was an effective alternative to surgery.




The expanded use addendum is a multi-center, prospective, non-randomized continued access trial.

A self-expanding TAVR valve, CoreValve (Medtronic Inc, Minneapolis, MN) was also studied in inoperable patients with AS, also termed ‘extreme risk’.5 The study met its primary endpoint of 12 month all-cause mortality or major stroke with a combined incidence of 26% at 1 year.

Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
You may at any time change the settings regarding cookies. The following chart shows 30-day or 1-year results from these clinical trials. Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis. This group included 45 patients at 8 hospitals in the United States. Some are essential to make our site work; others help us improve the user experience. This group included 639 patients at 41 hospitals in the United States. Prohibitive left ventricular outflow tract calcification. Aortic annulus diameter of <18 or >30 mm. ADVANCE is a multicenter, prospective, single-arm, observational study to evaluate safety and performance of the CoreValve system in a routine hospital setting with results out to 5 years. These patients were at high risk for surgery. Transcatheter Aortic Valve Replacement

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. With an updated browser, you will have a better Medtronic website experience. The Evolut PRO Study is a prospective, multicenter, controlled, non-randomized single-arm study. Patients The SMall Annuli Randomized To Evolut or Sapien (SMART) post-market trial will compare valve safety and performance of the self-expanding Medtronic Evolut PRO and PRO+TAVR …



All subjects will be treated with a Medtronic TAVR system. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions.

Patients were randomly put in the CoreValve procedure or surgery group.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? As an appendix study, 60 patients were studied with the 34 mm valve. Medtronic has now added to the evidence by releasing results from a clinical trial of its Evolut TAVR devices in bicuspid patients.



Yearly checkups will continue for 10 years. The Evolut R US Clinical Study is a prospective, multicenter, controlled, nonrandomized single-arm clinical study to evaluate the repositionable Evolut R system in patients deemed high or greater risk for surgery. aspirin or heparin (HIT/HITTS) and bivalirudin. The SURTAVI Trial is a prospective, randomized, multicenter, noninferiority study to compare the safety and efficacy of the Medtronic TAVR system* to SAVR in patients with symptomatic severe aortic stenosis at intermediate surgical risk. Evidence of an acute myocardial infarction ≤30 days before the study procedure due to unstable coronary artery disease (WHO criteria).

2020 Oct 7. doi: 10.1001/jamacardio.2020.4738.


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