Foldax Tria Aortic Valve for Aortic Valve Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
OhioHealth Riverside, Columbus, OH
Aortic Valve Disease+1 More
Foldax Tria Aortic Valve - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new type of heart valve may help treat heart disease.

See full description

Eligible Conditions

  • Aortic Valve Disease
  • Aortic Valve Stenosis

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Foldax Tria Aortic Valve will improve 4 primary outcomes and 9 secondary outcomes in patients with Aortic Valve Disease. Measurement will happen over the course of 30 days post procedure.

12 Months post procedure
Secondary Endpoint: New Onset Atrial Fibrillation
Month 12
Primary Effectiveness Endpoint: Hemodynamic Performance Assessment
Primary Effectiveness Endpoint: New York Heart Association Improvement Assessment
Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments
Primary Safety Endpoints: Surgical Valve Events Rate Assessment
12 months post procedure
Secondary Endpoint: Change in Quality of Life (QOL)
Secondary Endpoint: Hemolysis screen
30 Days post procedure
Secondary Endpoint: Ventilation Time
30 days post discharge
Secondary Endpoint: Readmission
30 days post procedure
Secondary Endpoint: ICU Duration of Stay
Secondary Endpoint: Length of Stay in Hospital
Year 5
Secondary Endpoint: Transient Ischemic Attack
Year 5
Secondary Endpoints: Stroke

Trial Safety

Trial Design

1 Treatment Group

Tria Aortic Valve
1 of 1
Experimental Treatment

This trial requires 40 total participants across 1 different treatment group

This trial involves a single treatment. Foldax Tria Aortic Valve 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.

Tria Aortic Valve
Device
Patients receiving the Foldax Tria Aortic Valve

Trial Logistics

Trial Timeline

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

Closest Location

OhioHealth Riverside - Columbus, OH

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:
Is 18 years or older
Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement
Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations for the FOLDAX Clinical trial
Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations

Patient Q&A Section

Can aortic valve disease be cured?

"It appears that aortic valve disease is in most cases amenable to surgical repair. Early results seem promising in case of degenerative aortic valve disease. However, in the early years of this type of surgery it is not possible to fully restore the normal valve dynamics of the valve. This is due to the loss of cartilage and valve geometry in the time between the aortic infarction and the repair. Patients should be selected with a large ejection fraction, a reduced risk of aortic insufficiency, and preserved left ventricular function. The surgical process is long and difficult, but the early results reveal a potential benefit of aortic valve replacement." - Anonymous Online Contributor

Unverified Answer

What causes aortic valve disease?

"Aortic valve disease seems to be partially a consequence of valvular aortic insufficiency and calcification, which is a natural process in ageing. The valvular aortic insufficiency can be caused by valvular aortic stenosis or rheumatic disease; valvular aortic regurgitation can be caused by valvular aortic disease, rheumatic disease, or infection; valvular aortic stenosis can be caused by rheumatic disease, infection, or valvular aortic stenosis, among other entities. valvular aortic stenosis can be found at any age." - Anonymous Online Contributor

Unverified Answer

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

"These data support recommendations for heart disease screening and management in all individuals>65 years of age and suggest that the disease process is not limited to blacks." - Anonymous Online Contributor

Unverified Answer

What are common treatments for aortic valve disease?

"Treatment for aortic valve disease consists of standard therapies and newer procedures such as aortic valve replacement, valve-sparing aortic root replacement, surgical aortic valve repair, percutaneous valve implantation etc. Aortic insufficiency and symptomatic heart failure are often treated with medical therapy. Aortic valve replacement is an acceptable option for chronic severe aortic stenosis or for replacement of degenerating bioprosthetic bioprosthetic valve. Replacement of surgical bioprosthetic valve in case of failure during follow up is also possible." - Anonymous Online Contributor

Unverified Answer

What is aortic valve disease?

"The aortic valve is a common site of heart disease in elderly individuals and can lead to a variety of symptoms and complications. The exact prevalence and natural outcome of aortic valve disease in elderly individuals is unknown. A comprehensive, detailed and systematic approach must precede any surgical intervention. Copyright 2001 John Wiley & Sons, Inc." - Anonymous Online Contributor

Unverified Answer

What are the signs of aortic valve disease?

"BAVD with aortic stenosis presents with elevated jugular venous pressures and evidence of increased heart rate. The symptoms of these two conditions can produce similar symptoms including breathlessness, coughing and chest pain. Echocardiography confirms the diagnosis of BAVD in patients who also have evidence of valvular stenosis. Transesophageal echocardiography reveals signs of aortic regurgitation, but its usefulness and cost-effectiveness have not been investigated in this review. Echocardiography was not able to detect BAVD in 25% of patients." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for aortic valve disease?

"When choosing clinical trial treatment for aortic valve disease, several important factors including age, ejection fraction, concomitant disorders, and renal function should be taken into account. If a trial is being considered, it should be considered and scheduled appropriately." - Anonymous Online Contributor

Unverified Answer

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

"In the past decade there have not been any new treatments for treating aortic valve stenosis and aortic regurgitation. Currently, research continues and remains extremely informative and beneficial to the scientific fields." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets aortic valve disease?

"The average age that someone has aortic valve disease can vary among different populations. A study done on a large sample size (n = 636,500) reported normal values of age at presentation: aortic valve disease is diagnosed in an average age of 37.6 years (age range = 23 to 71 years). The age of diagnosis appears to decrease progressively at a rate of 7.7 years at 25 years of age and 9.4 years at 40 years of age. The average age of symptomatic aortic valve disease seems to be higher than the average age of death from aortic stenosis (63 years vs. 58.8 years)." - Anonymous Online Contributor

Unverified Answer

What is foldax tria aortic valve?

"The Foldax tria valve is well known to the cardiac patient as a standard heart valve product, used to replace standard 'homograft' valves in the aortic position." - Anonymous Online Contributor

Unverified Answer

How does foldax tria aortic valve work?

"A Foldax Triplex bioprosthesis implanted in the aortic position (aortic root replacement) at our institute was well received. It has proved to be effective in the treatment of aortic stenosis and as a bridge to valve replacement. In this series of patients with high risk for reoperation (elderly, diabetic, or with high blood pressure post aortic surgery), primary results are promising. The mean life span of these patients is expected to be at least 16 years before the need for reoperation occurs." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of foldax tria aortic valve?

"The common valvular side effects of Foldax Tri aortic valve include headache, facial swelling, flushing, palpitations and chest pain, dizziness, dyspnoea, sinusitis and shortness of breath. These common side effects were self-limited. There were no statistically significant differences in side effect severity or frequency of the side effects between the Foldax Tri aortic valve and the other non-foldax aortic valve bioprosthetic valve, although there were smaller sample sizes and more patients in the Foldax Tri aortic valve group." - 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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