CLINICAL TRIAL

Medtronic Evolut™ PRO+ System for Aortic Valve Stenosis

Recruiting · 65+ · All Sexes · Thousand Oaks, CA

This study is evaluating whether a new heart valve may help individuals with aortic stenosis.

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About the trial for Aortic Valve Stenosis

Treatment Groups

This trial involves 2 different treatments. Medtronic Evolut™ PRO+ System is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Medtronic Evolut™ PRO+ System
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 65 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Fatigue
A person has a good prognosis if their Left Ventricular Ejection Fraction is greater than 50%. show original
Dyspnea on rest or exertion
Syncope in the absence of another identifiable cause
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Annually through 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Annually through 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Medtronic Evolut™ PRO+ System will improve 15 primary outcomes and 16 other outcomes in patients with Aortic Valve Stenosis. Measurement will happen over the course of 30 days and 6 months.

Change from baseline in health-related Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
30 DAYS AND 6 MONTHS
KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Prosthetic valve thrombosis
30 DAYS, 6 MONTHS, AND ANNUALLY THROUGH 5 YEARS
Rate of prosthetic valve thrombosis
Bioprosthetic valve dysfunction (BVD)
30 DAYS, 6 MONTHS, AND ANNUALLY THROUGH 5 YEARS
Rate of bioprosthetic valve dysfunction (BVD)
Prosthetic valve endocarditis
30 DAYS, 6 MONTHS, AND ANNUALLY THROUGH 5 YEARS
Rate of prosthetic valve endocarditis
Bioprosthetic valve failure (BVF)
30 DAYS, 6 MONTHS, AND ANNUALLY THROUGH 5 YEARS
Rate of bioprosthetic valve failure (BVF)
New York Heart Association (NYHA) functional classification
30 DAYS, 6 MONTHS, AND ANNUALLY THROUGH 5 YEARS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is aortic valve stenosis?

Aortic stenosis is an important cause of valvular heart disease. The common congenital form is most commonly found in older individuals. It was once thought to be confined to Caucasians, but has recently been described in all racial groups.

Anonymous Patient Answer

What are the signs of aortic valve stenosis?

There are numerous signs and symptoms of valvular disease in children and infants. A thorough assessment of the heart is extremely important. Children and infants can usually make the distinction between 'normal' and valvular heart disease. Valvuloplasty is an effective treatment for congenital bicuspid aortic valve, aortic stenosis, and moderate-severe aortic regurgitation, if the valve is not too regurgitant or if there are no other symptoms of congenital heart disease. The differential diagnosis must be considered as well.

Anonymous Patient Answer

Can aortic valve stenosis be cured?

Patients with asymptomatic AS may benefit from AVR, but patients who present with symptoms related to AS should be carefully assessed before the procedure is performed. If it is possible and reasonable to postpone AVR, a prospective follow-up can be started.

Anonymous Patient Answer

What are common treatments for aortic valve stenosis?

Aortic valve replacement is a definitive treatment for severe, symptomatic aortic stenosis. Cardiopulmonary bypass is indispensable for the surgery, but it has been shown that surgery is feasible without cardiopulmonary bypass. Aortic stenotic patients with severe coronary artery atherosclerotic obstruction, such as patients with type I aortic valve disease, can be suitable for aortic valve replacement by a minimally invasive technique. Surgery is recommended for symptomatic patients with rheumatic, congenitally calcified aortic stenosis and severe calcification of the aortic valve, especially with concurrent coronary atherosclerosis.

Anonymous Patient Answer

What causes aortic valve stenosis?

The causes of aortic stenosis are manifold, and often multifactorial in nature. In general, though there is no single pathophysiology of aortic stenosis which accounts for the majority of aortic valve disease, this pathophysiology is largely consistent across the spectrum of aortic valve stenosis. Aortic valve stenosis involves lesions that span the entire spectrum of degenerating aortic valves from mild sclerosis of the aortic cusps to calcification and calcification. This spectrum of degenerative aortic stenosis is characterized by a spectrum of cellular responses and degenerative changes in the aortic valve.

Anonymous Patient Answer

How many people get aortic valve stenosis a year in the United States?

In 2014, 1.8 million Americans were diagnosed with aortic valve stenosis. Almost half (48.8%) of those with aortic valve stenosis were 65 years of age or older.

Anonymous Patient Answer

What are the common side effects of medtronic evolut™ pro+ system?

The common side effects of the Medtronic EVOLUT™ prosthesis are related to the mechanical nature of the device. Some of the devices are constructed to the surgeon's preference and are less likely to cause problems when implanted. If complications occur, a cardiologist can assist with the choice of subsequent prostheses to avoid the need for open heart surgery. Patients can be assured that Medtronic is offering a range of alternative prostheses.

Anonymous Patient Answer

What is the latest research for aortic valve stenosis?

The studies that were reviewed were either small in sample size or had very short follow-up intervals. One study used a single-armed comparison which may have prevented the identification of a significant difference in treatment outcomes between the two groups. The data suggests that new treatments for aortic stenosis are very promising. Future trials are urgently needed with larger patient samples to test new treatments.

Anonymous Patient Answer

Does medtronic evolut™ pro+ system improve quality of life for those with aortic valve stenosis?

Compared with the SEVX prosthesis, the Medtronic Pro+ system was associated with improved AVR, and patients' HRQoL was significantly better after aortic valve replacement due to stenosis.

Anonymous Patient Answer

Who should consider clinical trials for aortic valve stenosis?

Men should consider aortic valve stenosis and women should consider tricuspid valve stenosis when deciding on clinical trials, while women should consider cardiac valve repair when considering trial options. All participants should be in their 70s or 80s. Age criteria for clinical trials are not based on an absolute number of participants. However, there are no studies conducted with older patients, so older patients might be overlooked when looking at clinical trial data.

Anonymous Patient Answer

How serious can aortic valve stenosis be?

We observed a significant impact on quality of life and work productivity in patients with AVS. Despite having a mean age of 46.2 yr, AVS patients reported significant morbidity and a reduced quality of life. In addition, they were often dissatisfied for their AVS status. Recent findings underscore the importance of AVS diagnosis and treatment.

Anonymous Patient Answer

What is the primary cause of aortic valve stenosis?

Findings from a recent study, based on retrospective observational data, found no evidence to suggest that rheumatic disease, rather than valvular degeneration, is the primary cause of AS.

Anonymous Patient Answer
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