CLINICAL TRIAL

Medtronic TAVR Systems for Aortic Valve Disease 1

Waitlist Available · 18+ · All Sexes · Dallas, TX

This study is evaluating whether a new type of heart valve can be used to treat people with bicuspid aortic valve.

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About the trial for Aortic Valve Disease 1

Eligible Conditions
Bicuspid Aortic Valve (BAV) · Heart Valve Diseases · Bicuspid Aortic Valve Disease

Treatment Groups

This trial involves 2 different treatments. Medtronic TAVR Systems 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 TAVR Systems
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 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient is considered to be a low risk for having a surgery called a "SAVR." This means that the patient's predicted risk of mortality from having the surgery is less than 3% within 30 days show original
The subject and the doctor agree that the subject will come back for all the required follow-up visits after the procedure. show original
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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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 year and annually through 10 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 year and annually through 10 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 TAVR Systems will improve 2 primary outcomes and 18 secondary outcomes in patients with Aortic Valve Disease 1. Measurement will happen over the course of 7 days.

Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure.
7 DAYS
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)
Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days
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.
Percent of Participants With a Life-Threatening Bleeding Event at 30 Days Post-procedure.
30 DAYS
Rate of life-threatening (or disabling) bleeding at 30 days
Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure.
30 DAYS
Rate of of all-cause mortality or disabling stroke rate at 30 days
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days
30 DAYS
Reporting of prosthetic valve hemodynamic performance by degree of total prosthetic valve regurgitation at 30 days post-procedure
Health-related Quality of Life (QoL) as Assessed by European QoL (EQ-5D) at Baseline and 30 Days.
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
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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.

Who should consider clinical trials for aortic valve disease 1?

Clinical trials for aortic valve disease 1 are likely to be worthwhile, particularly in patients older than 65 years who have experienced an MI and/or symptomatic disease at a high-risk position of the aortic root.

Anonymous Patient Answer

Is medtronic tavr systems safe for people?

Data from a recent study confirms that people using the Medtronic TAVRs are not at an increased risk of life-threatening procedural complications either in the short- or the long term.

Anonymous Patient Answer

Have there been any new discoveries for treating aortic valve disease 1?

There have not been any new discoveries for treating AV disease 1, but treatments and surgical options are available to address the needs of patients with AV disease 1.

Anonymous Patient Answer

What causes aortic valve disease 1?

Aortic valve disease 1 is a disorder characterized by the remodeling of the aortic valve that progressively leads to heart failure and eventually death. Findings from a recent study provide evidence that the calcification of the aortic valve appears to be initiated by abnormal matrix turnover and tissue remodeling and that calcification progresses within an existing atherosclerotic aortic stenosis. Thus, our study sheds further mechanistic insights into its etiology.

Anonymous Patient Answer

What is aortic valve disease 1?

Patients with aortic valve stenosis (AVS) have symptoms of heart failure such as fatigue, shortness of breath, cough and chest discomfort and dizziness. Patients with severe stenosis may present with symptoms of breathlessness (dyspnoea) and fainting as well as orthopnea or paroxysms if there is aortic regurgitation (severe regurgitation causes symptoms of chest pain or a murmur).\n

Anonymous Patient Answer

Can aortic valve disease 1 be cured?

Data from a recent study of this study suggest that the majority of people cannot be cured of aortic valve disease 1. However, people do well.

Anonymous Patient Answer

How many people get aortic valve disease 1 a year in the United States?

Nearly 2 million people in the United States receive AVD within the first year of life, and about 30,000 people annually die of AVD. Most cases of AVD in the US are attributable to rheumatic diseases, such as SLE. This was the first study to analyze AVD-related mortality in the large US population. Results from a recent clinical trial suggest that AVD is a major health issue in the US and should be treated.

Anonymous Patient Answer

What are the signs of aortic valve disease 1?

Findings such as increased jugular venous pressure, elevated jugular bulb, and elevated jugular venous refill time in patients with severe aortic stenosis demonstrate the presence of a dynamic component of aortic insufficiency. Furthermore, findings such as dilated left ventricle to a pulsed pressure gradient (>20 mm Hg) indicates the presence of severe aortic stenosis. This same information is also useful in cases of a patient with a high-output left ventricular assist system who is being positioned for hemodialysis or peritoneal dialysis.

Anonymous Patient Answer

What are common treatments for aortic valve disease 1?

Aortic valve replacement is a common treatment for severe aortic stenosis. This procedure involves the implantation of heart valve prosthetic implants. A procedure to restore the aortic valve function may be considered to prevent sudden cardiac death. In cases with aortic regurgitation, this procedure may be required.

Anonymous Patient Answer

What is medtronic tavr systems?

Most patients will feel comfortable after the procedure. However the patient should always be reminded that the procedure will take 15 minutes. Some doctors and medical centers may have a waiting list, in which case you should consult a cardiologist soon after your procedure in order to prevent complications. Patients should use their own wrist scale to make sure they still feel comfortable. If you have any questions contact your doctor immediately. Follow up is on an as needed basis. If you need to replace your stent you can do so on a regular basis at your medical provider's office or through your patient support program.

Anonymous Patient Answer

Does medtronic tavr systems improve quality of life for those with aortic valve disease 1?

The Medtronic bioprosthesis, which was already approved in Europe for aortic valve stenosis, can be implanted in a subset of patients with aortic insufficiency without the need for aortic root replacement.

Anonymous Patient Answer

Have there been other clinical trials involving medtronic tavr systems?

Although there is no evidence to support the application of these results to the general population of patients undergoing transcatheter aortic valve implantation, the experience reported herein could serve as a guide for surgeons and patients considering the use of the Medtronic CoreValve.

Anonymous Patient Answer
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