Medtronic TAVR Systems for Aortic Valve Disease 1
This study is evaluating whether a new type of heart valve can be used to treat people with bicuspid aortic valve.
See full descriptionAbout the trial for Aortic Valve Disease 1
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.
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.
Approximate Timelines
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.
Patient Q & A Section
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.