CardioMech MVRS for Mitral Valve Insufficiency

Phase-Based Estimates
1
Effectiveness
1
Safety
Mayo Clinic, Rochester, MN
Mitral Valve Insufficiency
CardioMech MVRS - Device
Eligibility
18+
All Sexes
Eligible conditions
Mitral Valve Insufficiency

Study Summary

This study is evaluating whether a new device can be used to repair mitral valves.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether CardioMech MVRS will improve 2 primary outcomes in patients with Mitral Valve Insufficiency. Measurement will happen over the course of 30 days.

30 days
Change in MR grade
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure

Trial Safety

Trial Design

2 Treatment Groups

Control
CardioMech Mitral Valve Repair System (MVRS)

This trial requires 15 total participants across 2 different treatment groups

This trial involves 2 different treatments. CardioMech MVRS 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.

CardioMech Mitral Valve Repair System (MVRS)
Device
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

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

Closest Location

Mayo Clinic - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Eighteen (18) years of age or greater
Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail
Intermediate or high surgical risk for mitral valve repair

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can mitral valve insufficiency be cured?

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The present study revealed a trend towards an improvement in patients' subjective satisfaction, but neither a significant change in exercise capacities nor a change in echocardiographic parameters. Thus, further long-term follow-up studies are warranted to evaluate the long-term results of surgical treatments for mitral regurgitation.

Unverified Answer

What is mitral valve insufficiency?

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A diagnosis of 'valve insufficiency' is a common finding in mitral valve echocardiography and has a high predictive value of severe regurgitation from the mitral valve.

Unverified Answer

What are common treatments for mitral valve insufficiency?

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The most common treatment for MVI is replacement with a mechanical-tissue valve. The durability of biologic tissue valves (durability of a valve to last for at least 10 years) is still debated.

Unverified Answer

What causes mitral valve insufficiency?

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Mitral valve insufficiency is a condition of the valve leaflets which has many causes both congenital and non-congenital. If the insufficiency is mild it is usually benign and does not require treatment, however if the patient has symptoms it is necessary for a surgical intervention to correct the problem.

Unverified Answer

What are the signs of mitral valve insufficiency?

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For surgeons in the context of valve replacement in mitral valve patients, mitral valve anatomy dictates that the surgeon should be aware of the signs of mitral insufficiency. The degree and severity of these signs can help surgeons predict the outcome of their patients, and plan their operative intervention. The presence of signs of moderate or severe mitral stenosis is associated with a greater requirement for cardiopulmonary bypass. While the presence of signs of moderate to severe mitral stenosis also is associated with an increased risk of cardiac morbidity and mortality, it can also be associated with a successful outcome in the context of mitral valve repair.

Unverified Answer

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

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About 10% of hospitalized patients in the United States are hospitalized for mitral insufficiency a year. Mitral valve disease is likely to be under-recognized by primary care physicians and subspecialists. Many patients with rheumatic disease have atypical presentations of mitral insufficiency which could result in undertreatment with appropriate therapy.

Unverified Answer

Has cardiomech mvrs proven to be more effective than a placebo?

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Cardiomech MV repair offers no advantage over a placebo in patients who were selected for the study based on severity of their symptomatic disease. There were some differences between the two groups in terms of ejection fraction and improvement in LVEF at follow-up. The use of percutaneous annuloplasty and replacement valve prostheses in addition to mitral valve repair appears to be associated with better results even when valve repair is carried out.

Unverified Answer

How serious can mitral valve insufficiency be?

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Mitral valve insufficiency and dysfunction appear to increase the risk for major adverse cardiac events compared with patients without severe mitral valve regurgitation. When clinical manifestations of mitral insufficiency occur, severe mitral regurgitation should be considered and echocardiography performed.

Unverified Answer

What is the average age someone gets mitral valve insufficiency?

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A normal MVA (< or =2 mm(2)). However, the age of presentation of patients with severe mitral regurgitation is typically in late adolescence or young adulthood, which is when the MVA is mostly normal or mildly abnormal. At this time, the prevalence of mitral regurgitation may be around 10% (compared with a low of 1%). Therefore, mitral regurgitation is an [obvious disease in its own right and not simply a precursor of [severe structural heart disease in later life] and it should not be ignored.

Unverified Answer

Is cardiomech mvrs safe for people?

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The cardiomech mvrs is a useful, safe, readily usable device that can be easily inserted in the interatrial groove and can be easily withdrawn without excessive trauma to the valve. However, its use in routine procedures remains elusive due to the high cost and the need for expertise in the placement in this delicate area of the heart.

Unverified Answer

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

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A novel catheter-delivered deoxycholate has been found to be a potential novel therapy for mitral valve repair in patients with severe valvular insufficiency and should be explored in a prospective study.

Unverified Answer

What are the latest developments in cardiomech mvrs for therapeutic use?

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Many factors influence the patient's outlook including the underlying etiology. The patient's age and cardiovascular comorbidity profile also influence the outcomes. Patient selection, optimization and post-procedural management can make a difference in optimizing clinical outcomes.

Unverified Answer
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