Treatment for Aortic Valve Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mission Health & Hospitals, Asheville, NC
Aortic Valve Disease+1 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a valve can be used safely for 5 years.

See full description

Eligible Conditions

  • Aortic Valve Disease
  • Aortic Valve Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 5 other outcomes in patients with Aortic Valve Disease. Measurement will happen over the course of Up to 7 days, 6 months, 3 years and 5 years post implant.

5 years post implant
Freedom from all-cause mortality
Freedom from structural valve deterioration
Freedom from surgical valve replacement or transcatheter valve implantation due to structural valve deterioration
Freedom from surgical valve replacement or transcatheter valve-in-valve implantation
Freedom from valve related mortality
Year 5
Valve hemodynamic performance

Trial Safety

Safety Progress

1 of 3

Trial Design

0 Treatment Group

This trial requires 363 total participants across 0 different treatment group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years post implant
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years post implant for reporting.

Closest Location

Mission Health & Hospitals - Asheville, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The subject must be willing and able to provide written consent to participate in this study. show original
The subject is a candidate for surgery to replace their aortic valve, and they are expected to have a St show original
The person is of legal age in the country where they are studying. show original
The subject must be willing and able to comply with all follow-up requirements. show original

Patient Q&A Section

What causes aortic valve disease?

"Results from a recent paper has indicated a genetic component to AV disease; however, other factors like diet and hormones may also play a role; further investigation is needed." - Anonymous Online Contributor

Unverified Answer

Can aortic valve disease be cured?

"For patients with severe disease, aortic valve surgery is often curative of symptoms in patients older than 60 years of age. Early surgical intervention (within 30 days) is correlated with better early and mid-term survival of patients." - Anonymous Online Contributor

Unverified Answer

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

"around 20 million Americans will develop valve disease due to the aortic valve. There will be approximately 10,000 new cases of aortic valve disease in the United States in 2022." - Anonymous Online Contributor

Unverified Answer

What are common treatments for aortic valve disease?

"Most patients with aortic stenosis or regurgitation require surgical valve replacement. However, some patients with aortic stenosis or aortic stenosis and left ventricular dysfunction may be treated with catheter ablation of the accessory pathway, with success rates comparable to those of surgery, or may be treated with cardiac resynchronization therapy." - Anonymous Online Contributor

Unverified Answer

What is aortic valve disease?

"Left ventricular dysfunction is common in adults 50 years of age or beyond. In adults with symptomatic aortic insufficiency or ascending aortic aneurysm, there must be a high index of suspicion for occult aortic valve disease (disease of the heart valves) such as rheumatic aortic stenosis. Aortic insufficiency should be treated by minimally invasive surgical aortic valve replacement because its long-term durability compares favorably with the bioprosthetic artificial valve. The incidence of ascending aortic aneurysm, however, is not known because routine screening is still not generally accepted; therefore, it is more likely that the incidence is relatively low." - Anonymous Online Contributor

Unverified Answer

What are the signs of aortic valve disease?

"Aortic valve disease may present several symptoms because of obstruction to the outflow of blood from the left side of the heart. The main symptoms are dyspnea on exertion, cough, chest pain during coughing, and sudden unexplained weight loss. The first symptom of aortic valve stenosis that the physician encounters often is fatigue. Other specific, often more serious signs and symptoms include fainting or a sudden stop in breathing. All signs are due to obstruction to the outflow of blood. Most patients do not have these symptoms at an early stage of the disease." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with aortic valve disease?

"Based on the results of this study, treatment with ACEI/ARB was better than medical treatment alone in improving HRQOL. Although ACEI and ARB were equivalent in improving HRQOL, the use of ACEI or ARB was correlated with the treatment choice and age at the start of treatment and the clinical severity of the disease." - Anonymous Online Contributor

Unverified Answer

Is treatment safe for people?

"Given a high probability of serious complications associated with surgical treatment, nonoperative care is recommended for degenerative disease of the aortic valve, as it remains as effective as surgical intervention when used in symptomatic patients. In symptomatic patients with normal mitral valves, surgical aortic valve replacement is recommended. However, surgical intervention is associated with significantly higher long-term mortality than nonoperative care in symptomatic patients with normal mitral valves." - Anonymous Online Contributor

Unverified Answer

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

"There has not been any breakthrough in treating aortic valve disease. Current research continues to seek to improve outcomes through better understanding of the pathologic processes responsible for aortic valve disease. Further clinical and preclinical research is underway to elucidate how specific molecules, and specific genes and pathways, influence valve disease progression and progression to cardiac valve replacement to improve outcomes and outcomes of the disease." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets aortic valve disease?

"There are very few national data on AVD; thus, the mean age of onset of AVD is difficult to identify from a single retrospective survey of a single referral region. Despite this caveat, it is reasonable to hypothesize that many patients have AVD diagnosed by age 60 and the average age of diagnosis for AVD is around 63 years." - Anonymous Online Contributor

Unverified Answer

How serious can aortic valve disease be?

"Data from a recent study, severe aortic stenosis was associated with low cardiac and renal event-free survival; advanced age, high New York Heart Association functional class, severe left ventricular dysfunction, and elevated pulmonary arterial pressures were predictive of a worse prognosis. Patients with severe aortic stenosis may benefit from treatment with aortic valve prosthesis." - Anonymous Online Contributor

Unverified Answer

What does treatment usually treat?

"Patients are not generally being diagnosed and treated for an incidental finding of AS, and patients with AS are likely to be treated by surgeons who treat heart valve disease. The [Journal of Cardiovascular Surgery]'s annual ASCP meeting in 2010 [provided the opportunity to discuss some of this information with surgical colleagues and other healthcare professionals who can assist in diagnosing and treating AS] (http://jcs.asm.org/content/65%3A8%9A%90%9A%9C%9Adissection%2C.pdf)." - Anonymous Online Contributor

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