Edwards Cardioband System for Mitral Valve Insufficiency

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sanger Heart & Vascular Institute - Atrium Health, Charlotte, NC
Mitral Valve Insufficiency+1 More
Edwards Cardioband System - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new device can be used to treat heart problems.

See full description

Eligible Conditions

  • Mitral Valve Insufficiency
  • Mitral Regurgitation Functional

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Edwards Cardioband System will improve 1 primary outcome and 5 secondary outcomes in patients with Mitral Valve Insufficiency. Measurement will happen over the course of 30 days.

1 year
Functional improvement (KCCQ)
Functional improvement (NYHA Class)
Functional improvement (increase in 6 MWT distance in meters)
Heart failure hospitalizations
Prevalence of MR ≤ 2+ and hierarchical comparison of device and control groups including time to cardiovascular death, number of heart failure hospitalizations, improvement in 6 MWT distance (in meters) and KCCQ (number of points improved).
30 days
Rates of various adverse events (device group only)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control
1 of 2
Edwards Cardioband System
1 of 2
Active Control
Experimental Treatment

This trial requires 375 total participants across 2 different treatment groups

This trial involves 2 different treatments. Edwards Cardioband System 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.

Edwards Cardioband System
Device
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
ControlGuideline directed medical therapy (GDMT)

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

Sanger Heart & Vascular Institute - Atrium Health - Charlotte, NC

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
Age > 18 years;
Clinically Significant Functional Mitral Regurgitation (MR);
Symptomatic heart failure;
Patient hospitalized due to heart failure during 12 months prior to submission to Central Screening Committee OR elevated Brain Natriuretic Peptid (BNP);
Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit compliance.

Patient Q&A Section

What causes mitral valve insufficiency?

"Mitral stenosis is caused by valve thickening due to calcific deposits, which alter the normal functioning of the valve. Mitral insufficiency can cause valvular stress and abnormal heart function, but other causes should be ruled out." - Anonymous Online Contributor

Unverified Answer

Can mitral valve insufficiency be cured?

"With appropriate management, mitral insufficiency is a relatively benign condition and can be cured by surgical repair or valve replacement with or without concomitant aortic valve repair." - Anonymous Online Contributor

Unverified Answer

What is mitral valve insufficiency?

"The mitral valve performs two important roles in the heart. First, it separates the two main blood-producing chambers, the left atrium and the right ventricle. Second, it prevents blood from flowing backward from the ventricle into the backward-flowing left atrium. With a properly-functioning mitral valve, these important functions are performed by valves attached to the mitral valve. But with a mitral valve that becomes obstructed by a gradual calcification, blood is able to flow backward from the ventricle into the atrium and the left ventricle is no longer filled with oxygen-rich blood." - Anonymous Online Contributor

Unverified Answer

How many people get mitral valve insufficiency a year in the United States?

"About 2 million people experience mitral insufficiency or regurgitation in the United States each year. This is 2.1% of the U.S. population. Half of the people experience valve regurgitation. About 10-13% of the population experienced a cardiac event related to mitral regurgitation (regurgitation or sudden deaths) in the U.S. in the past year. About 50% of the people who get mitral regurgitation experience other valve diseases, such as leaflet tears. Most people with mitral insufficiency or regurgitation can live with their disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for mitral valve insufficiency?

"Given the limitations of surgical outcomes, percutaneous approaches will continue to play a vital role for patients with mitral leakage and will remain a first-line treatment." - Anonymous Online Contributor

Unverified Answer

What are the signs of mitral valve insufficiency?

"Signs and symptoms of mitral valve insufficiency include a palpable second heart sound, tachycardia, chest pain and palpitations. There is a slight increase in transmitral pressure gradient with exercise." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of mitral valve insufficiency?

"The primary cause of mitral insufficiency is mitral regurgitation, either in a congenital or acquired setting. Mitral insufficiency may be a late clinical finding in some patients who have a cardiomyopathy. Mitral insufficiency may also be the explanation for cardiomyopathies in patients with no dilated left ventricle and no systolic or diastolic abnormality on clinical examination." - Anonymous Online Contributor

Unverified Answer

How serious can mitral valve insufficiency be?

"Patients with symptomatic ischemic mitral regurgitation may present with impaired cardiac reserve and left ventricular function. However, in the absence of any other evidence of underlying cardiac disease, the prognosis for patients with ischemic mitral regurgitation appears favorable. The treatment of choice for ischemic mitral regurgitation remains repair if possible." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets mitral valve insufficiency?

"Age is an important determinant for the occurrence of mitral valve dysfunction in this population. Mitral insufficiency is associated with more atherosclerotic disease in the coronary arteries and a higher incidence of myocardial infarction." - Anonymous Online Contributor

Unverified Answer

Is edwards cardioband system typically used in combination with any other treatments?

"In most cases of mitral stenosis and mitral insufficiency, the use of BMS with another treatment option is not more effective than using a combination of other treatment options. There may be individual cases where this approach is a reasonable option." - Anonymous Online Contributor

Unverified Answer

Does mitral valve insufficiency run in families?

"MVI is not a hereditary disease, since no evidence of genetic defect was seen by family history analysis. Although MVI occurs in 1% of the general population, its occurrence in family members seems to be the result of some unknown environmental factor(s)." - Anonymous Online Contributor

Unverified Answer

What is edwards cardioband system?

"The balloon was successfully placed in 97 % of patients and, when placed under appropriate conditions, is a low-risk intervention that provides a good result with minimal morbidity or mortality." - 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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