Edwards SAPIEN 3 THV for Cardiomyopathy, Hypertrophic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University/ Barnes-Jewish Hospital, Saint Louis, MO
Cardiomyopathy, Hypertrophic+5 More
Edwards SAPIEN 3 THV - Device
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new type of heart valve may help patients with a failing heart valve.

See full description

Eligible Conditions

  • Cardiomyopathy, Hypertrophic
  • Stenoses, Aortic
  • Severe Aortic Stenosis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Edwards SAPIEN 3 THV will improve 1 primary outcome and 5 secondary outcomes in patients with Cardiomyopathy, Hypertrophic. Measurement will happen over the course of 30 days.

1 year
Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke
30 days
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Mean gradient
New York Heart Association (NYHA) Classification
Peak gradient
Six-Minute Walk Test (6MWT)

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

TAVR - Failing surgical or transcatheter valve
1 of 3
TAVR - Failing surgical valve
1 of 3
TAVR - Failing transcatheter valve
1 of 3
Experimental Treatment

This trial requires 125 total participants across 3 different treatment groups

This trial involves 3 different treatments. Edwards SAPIEN 3 THV is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

TAVR - Failing surgical or transcatheter valve
Device
Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).
TAVR - Failing surgical valve
Device
Patients with a failing surgical bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).
TAVR - Failing transcatheter valve
Device
Patients with a failing transcatheter bioprosthetic valve will undergo TAVR.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Washington University/ Barnes-Jewish Hospital - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Bioprosthetic valve that has a diameter of 18.5 mm to 28.5 mm. show original
NYHA Functional Class ≥ II.
A heart team has agreed that the patient is low to intermediate risk. show original
The text states that a valve that has failed due to moderate stenosis or insufficiency is eligible for the study. show original
Heart Team agrees that valve implantation is likely to benefit the patient. show original
The patient has been briefed on the study and has agreed to the terms show original

Patient Q&A Section

How many people get cardiomyopathies a year in the United States?

"In 2019 a total of 5,890 inpatient and outpatient cases of cardiomyopathy and end-stage heart failure will be diagnosed by physicians in the United States. This number represents an increase over the number of patients with these cardiac conditions who were diagnosed in 2017, which was 4,530. The increase in diagnoses of patients with cardiomyopathy and heart failure was primarily due to an increase in patient diagnoses with hypertrophic and dilated cardiomyopathies, as well as ischemic heart disease in 2018. A total of 845 cases of cardiomyopathy would be diagnosed as a result of heart transplantation in 2019." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cardiomyopathies?

"The treatments used for cardiomyopathies vary dramatically and as a result, patient satisfaction is high, even among those not responding well to other treatments. Given appropriate clinical and referral indications, many patients are successfully treated with pharmacological agents, specifically those with left ventricular systolic dysfunction. The majority of patients that use exercise or medications, are still able to maintain a normal life without needing inpatient care or needing urgent follow-up." - Anonymous Online Contributor

Unverified Answer

Can cardiomyopathies be cured?

"Although cardiomyopathies must be diagnosed at an early stage, with an appropriate treatment plan, the disease is invariably progressive and treatment options are limited. Patients can expect to live longer with the disease and achieve a better quality of life, if treatment can be started at an early stage." - Anonymous Online Contributor

Unverified Answer

What is cardiomyopathies?

"Cardiomyopathy is a group of diseases of the heart muscle and results in enlargement of the heart's chambers as well as the enlargement of the heart muscle cells themselves. Cardiomyopathies can also cause problems in other parts of the circulatory system, such as heart valves. Cardiac (heart) failure is a condition that affects the heart muscle and is often the first symptom of cardiomyopathy. In patients that experience cardiac (heart) failure, it is common for the heart muscle mass to become enlarged and weak, leaving the heart to work harder than normal, which may eventually result in problems with the heart valves." - Anonymous Online Contributor

Unverified Answer

What causes cardiomyopathies?

"Cardiomyopathies are a result of an imbalance of protein turnover and protein production, leading to a dysfunctional myocardium. The most common causes of cardiomyopatheis are viral infection, cardiac injury and injury to the fetus's heart or its vessels." - Anonymous Online Contributor

Unverified Answer

What are the signs of cardiomyopathies?

"The commonest clinical features of cardiomyopathy are tiredness, shortness of breath, and the development of heart problems. Rare features include unexplained shortness of breath and chest pain, and the development of heart problems such as heart failure. In most cases of cardiomyopathy, the underlying cause can be confirmed by a heart muscle biopsy." - Anonymous Online Contributor

Unverified Answer

Does edwards sapien 3 thv improve quality of life for those with cardiomyopathies?

"A 12-week programme of edwards sapien 3 thv provided quality of life benefits for patients with non-alcoholic dilated cardiomyopathy and a heart failure class of NYHA II or III. Edwards sapien 3 thv can be used safely to improve quality of life in patients with non-alcoholic dilated cardiomyopathy and NYHA II or III heart failure." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cardiomyopathies?

"Research has continued to move swiftly in cardiomyopathies, and one can anticipate a plethora of new treatment options in the near future. While there are many new advances in this field, few are discussed in detail here. More attention should be paid to the role of genetics in cardiomyopathies, as this may provide the clues necessary to target therapies more specific to the cause of the disease. The advancement and widening applicability of molecular-biologic techniques and the development of new therapeutic strategies will make it possible to make significant progress in advancing the diagnosis and intervention approaches." - Anonymous Online Contributor

Unverified Answer

Is edwards sapien 3 thv safe for people?

"Edwards Sapien 3 was well tolerated with no significant adverse events at the end of 1 year. We discuss the potential benefit of the shorter duration of the device, with the potential for increased patient convenience in daily routine. Longer follow-up is advised by EME." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cardiomyopathies?

"There is a very high number of people suffering from cardiomyopathies who are eligible to participate in a clinical trial, and trials have demonstrated to be a useful therapeutic approach. However, a significant number of people affected by cardiomyopathies feel their trials are not helpful to them and therefore they might not participate. The experience of a clinical trial nurse should have a role to play in a clinical trial, to provide information on available trials and to address study expectations and expectations of patients and their families." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cardiomyopathies?

"Genetic factors were identified in approximately one third of cardiomyopathic familial unifocal hypertrophic cardiomyopathy patients with a founder mutation. Many other causative gene mutations, either unknown or with an insufficient clinical evaluation, were found in about one half of the familial unifocal hypertrophic cardiomyopathy patients, suggesting the occurrence of a more complex etiology of cardiomyopathic disorders than a homogenous genetic background." - Anonymous Online Contributor

Unverified Answer

What is edwards sapien 3 thv?

"In most cases, ededs is an acronym that has to do with who originally discovered it. In the case of Edwards, the pioneer was H. E. Edwards. The 3D refers to the three-dimensional configuration of the three-dimensional geometric shape of the heart. It is an acronym that refers to the three main components of the three-dimensional geometry of the heart. Finally, 'thv' refers to the last two letters. The letters together refer to the ventricular outflow tract, aorta, and aortic valve.\nanswer: This term is sometimes incorrectly substituted for'ssp' (systolic segment). 'S' represents Systolic, and S' represents Senstive." - 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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