Cardiovalve Transfemoral Mitral Valve for Mitral Valve Insufficiency

1
Effectiveness
1
Safety
Piedmont Heart Institute, Atlanta, GA
Mitral Valve Insufficiency
Cardiovalve Transfemoral Mitral Valve - Device
Eligibility
18+
All Sexes
Eligible conditions
Mitral Valve Insufficiency

Study Summary

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

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Cardiovalve Transfemoral Mitral Valve will improve 2 primary outcomes and 7 secondary outcomes in patients with Mitral Valve Insufficiency. Measurement will happen over the course of 30 Days.

30 Days
Cardiovalve Technical Success
Cardiovalve to be implanted without Major Device Related Adverse Events through 30 Days including
Month 6
6-minute walk test (6MWT) distance
Change in LV end diastolic volume index (LVEDVI)
Change in LV end systolic volume index (LVESVI)
Changes in New York Heart Association (NYHA) functional class
Clinical Frailty Score
Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Mitral Regurgitation severity

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Cardiovalve Transfemoral Mitral Valve

This trial requires 15 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cardiovalve Transfemoral Mitral 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.

Cardiovalve Transfemoral Mitral Valve
Device
Replacement valve delivered through a transfemoral access and transseptal approach
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days, 3 months, 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30 days, 3 months, 6 months for reporting.

Closest Location

Piedmont Heart Institute - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
85>Age ≥ 18 years
Symptomatic (Stage D) severe MR confirmed by the echo core lab
Cardiac Index > 2.0
Left Ventricular Ejection Fraction (LVEF) is ≥ 30% (within 90 days prior to subject enrollment based upon TTE)
New York Heart Association (NYHA) Functional Class II, III or ambulatory IVa
Prior treatment with Guideline Directed Medical Therapy (GDMT) for heart failure for at least 30 days prior to index procedure
Patient deemed a high surgical risk per MVARC definition by the site's Heart Team (as a minimum, one MV cardiac surgeon and one interventional cardiologist, and a cardiac imaging expert).

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 causes mitral valve insufficiency?

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Data from a recent study confirms the role played by cardiac aging, and establishes, for the first time, that the mitral valve dysfunction is a cause of organic heart diseases.

Unverified Answer

What does cardiovalve transfemoral mitral valve usually treat?

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Cardialungual or anterior mitral leaf-to-leaf mitral valve replacement with a homograft can help correct the cardiology symptoms of patients with a nonfunctional posterior mitral valve, aortic rhepatitis or both, and is an alternative option to surgical replacement with either a heterograft or autograft.

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

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In 2006, the United States population has over 8 million people with mitral valve insufficiency. This number is expected to increase by 21% in 2009. This increase is likely attributable to the increasing population of elderly US citizens.

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What are common treatments for mitral valve insufficiency?

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Valvuloplasty surgery has been known to improve symptoms, such as breathlessness, chest pain, and limitation in daily activities, for over 50 years. The most common surgical treatment of mitral valve disease is valve replacement surgery (mitral valve replacement or mitral reconstruction). Other common surgical options included surgical repair or replacements of the mitral valve for rheumatic and degenerative disease. For prosthetic repair, one can choose mechanical or tissue valve (surgically created tissue, or tissue on a human cadaveric valve). Mechanical valves are more commonly used nowadays when the valve is repaired, especially when a bioprosthetic replacement is not available. The first valve surgery was done by Ross MacMasters and Dr.

Unverified Answer

Can mitral valve insufficiency be cured?

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Mitral insufficiency can be cured if the appropriate interventions are applied and if a preoperative evaluation is performed correctly, by echocardiography and cardiac magnetic resonance imaging. Severe cases can be treated in situ with valvuloplasty, an open-heart operation. Moderate mitral regurgitation can be treated with repair. Severe mitral regurgitations need a valve replacement.

Unverified Answer

What is mitral valve insufficiency?

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[If the mitral valve insufficiency patient has heart failure, then it is necessary to correct the mitral valve insufficiency to avoid worsening of the heart failure. Otherwise, the patient does not need mitral valve insufficiency intervention.] By using the mitral valve insufficiency patient as the control, we analyzed the effect of mitral valve insufficiency and found that, if the mitral valve insufficiency patient has heart failure, then it is necessary to correct the mitral valve insufficiency to avoid worsening of the heart failure. Otherwise, the mitral valve insufficiency patient does not need mitral insufficiency intervention.

Unverified Answer

What are the signs of mitral valve insufficiency?

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Patients with mitral insufficiency may be unaware of the severity of their symptoms. The history may be non-specific. The physical examination often points to an increased jugular venous pressure and pulmonary edema with a pansystolic rumble heard on auscultation and a loud popping sound when the left heart valve is moved out of position.\n

Unverified Answer

Is cardiovalve transfemoral mitral valve typically used in combination with any other treatments?

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The CVV technique is a reliable and safe treatment, with a low recurrence rate. This kind of transfemoral valve combined with standard mitral valve techniques is a viable alternative for treatment of bicuspid, mitral regurgitation, or coexistent mitral valve insufficiency.

Unverified Answer

What is the primary cause of mitral valve insufficiency?

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A large number of patients presenting to the cardiologist with mitral insufficiency are found at autopsy to have had a bacterial endocarditis. In the absence of an identifiable cause, it is reasonable to consider a bacterial cause for mitral leakage.

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Have there been any new discoveries for treating mitral valve insufficiency?

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There are several medications currently being studied, but there is no known 'quick' or'magical' cure, so patients who are seriously symptomatic are still recommended surgical treatment. If surgery is not an option, medications such as ACE inhibitors are sometimes used. There are also new surgical techniques, such as mitral annuloplasty (MAPP). Mitral valve bioprosthesis is often preferred, but mechanical valves show excellent long-term survival, and may be better over long-term than bioprosthesis.

Unverified Answer

Has cardiovalve transfemoral mitral valve proven to be more effective than a placebo?

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Treatment with an oral cardiocompetent compound (valved or valved, and with a physiologically reasonable prosthetic membrane) over six months was not associated with improvement in LV function. Neither did it improve the clinical symptoms of CHF in mild to moderate functional class III patients. It was found that there were no clinical differences between the treatment groups in respect to the echocardiographic variables during the study.

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What are the common side effects of cardiovalve transfemoral mitral valve?

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Cardiovalve transplantation may be associated with a high risk of bleeding complications and device malfunction. These data may suggest that the transaortic approach should be reserved for patients who are at high risk for bleeding.

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