CLINICAL TRIAL

TAVR for Aortic Valve Stenosis

Class II
Waitlist Available · 18+ · All Sexes · Seattle, WA

This study is evaluating whether a new heart valve can be safely used in patients with heart disease.

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About the trial for Aortic Valve Stenosis

Eligible Conditions
Symptomatic Severe Aortic Stenosis · Aortic Valve Stenosis

Treatment Groups

This trial involves 2 different treatments. TAVR 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.
TAVR
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAVR
2019
N/A
~5140

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 experiences symptoms from the aortic valve stenosis, as shown by having a NYHA Functional Class of II or greater. show original
The heart team has agreed (and verified in the case review process) that valve implantation will likely benefit the patient. show original
The study patient or their legal representative has been informed of the nature of the study, agrees to its provisions and has given written consent, which has been approved by the Institutional Review Board (IRB) of the respective clinical site. show original
The patient has a severe form of aortic valve stenosis that limits blood flow from the heart to the rest of the body show original
The patient agrees to comply with all required follow-up visits, including annual visits through 5 years and phone follow-up visits for analysis close date. 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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 year.
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 TAVR will improve 1 primary outcome and 1 secondary outcome in patients with Aortic Valve Stenosis. Measurement will happen over the course of 30 Days.

Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days
30 DAYS
30 DAYS
Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate
1 YEAR
1 YEAR

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 are common treatments for aortic valve stenosis?

Data from a recent study shows that more than half of patients undergoing AVR have experienced at least one post AVR PVD. Most patients will have at least one new PVD after AVR.

Anonymous Patient Answer

What are the signs of aortic valve stenosis?

Abnormal sound from the valve is the only consistent physical finding; signs include holosystolic murmur, holophilic trimmings, mid-diastolic click, mid-systolic click, and post-systolic murmur. For unknown reasons, men are more likely to present with aortic valve stenosis than women.

Anonymous Patient Answer

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

About 1.7 million persons a year get aortic valve stenosis, making it the third most common problem with the heart in US adults. The prevalence of aortic stenosis varies from 5.4% to 10.9% across the life span. This condition worsens with age and accounts for about 60% of all cases of heart failure.

Anonymous Patient Answer

What is aortic valve stenosis?

Stenosis is common in patients evaluated for aortic stenosis, but it rarely causes symptoms. The echocardiograph can be used reliably as a diagnostic tool with good correlation to the severity of the disease.

Anonymous Patient Answer

Can aortic valve stenosis be cured?

Even though satisfactory symptom control may be obtained, the long-term results (particularly in AVR) are often unsatisfactory because of recurrent worsening of symptoms or sudden deterioration.

Anonymous Patient Answer

What causes aortic valve stenosis?

In most cases of aortic stenosis the cause is related to high blood pressure. In about one in 200 cases, the cause is unknown (idiopathic). If systolic blood pressure is between 80 and 100 mmHg the patient should have a heart valve examination to assess the severity of the stenosis; this procedure is often followed by surgery.

Anonymous Patient Answer

What does tavr usually treat?

There is significant variability among providers with regard to what constitutes treatment for aortic valve stenosis. In a recent study of patients with severe aortic stenosis, only 36.6% of providers cited cardiac symptoms as a primary reason for surgery. Although many patients underwent aortic valve replacements, only 16.1% of providers cited them as the primary treatment decision. For most patients, the main reason for treatment modification was a worsening level of cardiac symptoms. Other common reasons include patient demand or patient preference, as well and the presence of other concomitant disease.

Anonymous Patient Answer

What are the latest developments in tavr for therapeutic use?

These developments include use of second-generation tavr for therapeutic use, as well as the possibility that tavr could help treat other pathologies such as atrial fibrillation with the potential for improved outcomes.

Anonymous Patient Answer

What is tavr?

[TAVI (tricuspid valve insufficiency) is a technique to treat acute severe Tricuspid aortic stenosis in both sexes and for all symptomatic and symptomatic asymptomatic patients. We know that this technique is under studies, so we will update you on their advancement]

Anonymous Patient Answer

Does aortic valve stenosis run in families?

Aortic valve stenosis is not inherited in an autosomal dominant manner. As a result, screening is strongly advised for all siblings of both aortic valve stenosis patients and those at high risk for aortic valve stenosis.

Anonymous Patient Answer

What is the latest research for aortic valve stenosis?

The development of new surgical techniques is an ongoing medical field but some of them appear to be better than standard surgical repairs. Especially in patients with valvular aortic stenoses, who have a high incidence of late failure and a low 5-year survival rate, the use of autologous cell therapy, gene therapy, stem cell therapy, and tissue engineering techniques may offer the best alternatives for the future. The following are some of the issues related to aortic valve stenosis: age, gender, genetic factors, size of the aortic valve, presence or absence of heart murmurs, and level of left ventricular hypertrophy.

Anonymous Patient Answer

What are the common side effects of tavr?

Common side effects of tavr were headache, dyspsia, back ache, and gastrointestinal discomfort. More serious side effects of tavr were headache and back pain. Patients with valvular disease on a regular treatment regimen should be monitored closely by their doctor.

Anonymous Patient Answer
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