Percutaneous mitral valve repair for Coronary Artery Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Ottawa Heart Institute, Ottawa, Canada
Coronary Artery Disease+1 More
Percutaneous mitral valve repair - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Coronary Artery Disease

Study Summary

This study is evaluating whether a surgical or percutaneous approach to treat ischemic mitral regurgitation is better for patients with coronary artery disease.

See full description

Eligible Conditions

  • Coronary Artery Disease
  • Mitral Valve Insufficiency

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Percutaneous mitral valve repair will improve 4 primary outcomes and 6 secondary outcomes in patients with Coronary Artery Disease. Measurement will happen over the course of Within 12-months of intervention.

Month 12
Hospitalization rate for congestive heart failure
Mortality rate
Rate of Stroke
Rate of myocardial infarction
Within 12-months of intervention
Cumulative hospital days
Month 12
Change in indexed left atrial volume
Degree of left ventricular remodeling
Number of Participants with worsening in heart failure symptoms
Presence of recurrent MR ≥2+
Within12 months of intervention
Rate of mitral valve re-intervention

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Mitral valve surgery
Percutaneous mitral repair

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. Percutaneous Mitral Valve Repair 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.

Percutaneous mitral repair
Procedure
Percutaneous mitral repair +/- coronary artery bypass grafting within 14 days of mitral repair.
Mitral valve surgery
Procedure
Surgical mitral valve surgery +/- coronary artery bypass grafting

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 6 and12 months of intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly within 6 and12 months of intervention for reporting.

Closest Location

University of Ottawa Heart Institute - Ottawa, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients who have severe ischemic Mitral regurgitation, as defined by the 2017 American Society of Echocardiography guidelines for noninvasive evaluation of native valvular regurgitation. show original
The presence of reversible myocardial ischemia has been confirmed by a preoperative myocardial viability study using radionuclide imaging. show original

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 are the signs of coronary artery disease?

Add answer

We have found evidence that the presence of the signs of premature cardiovascular disease (signs of CHD, heart attack, or stroke) increases a patient's risk for developing advanced stages of coronary artery disease. Further work with larger study groups is needed to clarify this relationship more completely.

Unverified Answer

Can coronary artery disease be cured?

Add answer

There appear to be benefits of regular exercise and avoidance of smoking, eating a healthy diet, and controlling hypertension. A healthy, lifestyle is an effective treatment for chronic coronary artery disease.

Unverified Answer

What are common treatments for coronary artery disease?

Add answer

Appropriate use of revascularization is widely practiced but high quality evidence is lacking. Aspirin and beta-blockers are not recommended for prevention of recurrent coronary events for patients with stable CAD.

Unverified Answer

How many people get coronary artery disease a year in the United States?

Add answer

The American Heart Association estimates that there will be around 806,000 new diagnoses of CAD between 2003 and 2030 in the US. This represents an absolute increase of 27% in diagnoses between 2003 and 2030. The projected increase over time, at 5 years, of 7.6% will be very similar to the absolute number of people with coronary disease. The difference in absolute numbers is due, at least in part, to the different inclusion criteria and diagnostic tools used in the two analyses.

Unverified Answer

What is coronary artery disease?

Add answer

Approximately 2.8 million people in Canada have at least one stenosis severity rating of one or more coronary arteries. The rates are highest among the male and elderly population. More than 75% also have CAD, and half have evidence of previous disease. The occurrence and severity of CAD are predicted by age, sex, risk factors, co-morbidities, and ethnicity. CAD is the third most common cause of acute coronary syndrome in Canada, accounting for one in three cases. It also plays a significant role in predicting future death from CAD. The most common manifestation of CAD is unstable angina, followed by non-ST-segment elevation myocardial infarction.

Unverified Answer

What causes coronary artery disease?

Add answer

There is accumulating evidence that both genetics and the environment play a significant role in the development of CAD. There is also strong evidence that a combination of these factors are involved in the pathogenesis of the disease.

Unverified Answer

Have there been any new discoveries for treating coronary artery disease?

Add answer

Yes, there have been new discoveries but they are limited to new methods of treatment of angina, including cardiac resynchronisation therapy (CRT). CRT may help reduce death for patients with severe coronary artery disease. CRT combines the idea that the heart muscle beats more forcefully due to abnormal electrical conduction between the heart chambers, which is known as heart failure, with the concept that the heart muscle can contract more forcefully more easily than heart muscle if abnormal electrochemical signalling can be corrected, therefore aiding heart muscle contraction. For example, if the abnormal heart muscle activity is caused by abnormal electrical contraction (e.g.

Unverified Answer

How serious can coronary artery disease be?

Add answer

Most individuals with coronary artery disease remain asymptomatic. Only a minority will be hospitalized with myocardial infarction per year despite being in high risk categories due to smoking, hypertension, and low levels of exercise.

Unverified Answer

What does percutaneous mitral valve repair usually treat?

Add answer

This retrospective review found that a high percentage of patients with [dilated mitral regurgitation were treated with percutaneous mitral valve repair. Patients with rheumatic mitral regurgitation received repair at a slightly lower rate, but there was no difference in their clinical outcomes.] There was a significant rate of postprocedural and long-term improvement and an acceptable number of complications. It seems that patients with rheumatic mitral regurgitation and [dilated mitral regurgitation who were treated with percutaneous valve repair had comparable outcomes. Patients with rheumatic MR and [dilated mitral regurgitation who were treated with [percutaneous valves repair had significantly better clinical outcomes.

Unverified Answer

What is the latest research for coronary artery disease?

Add answer

In recent years, coronary artery disease has become the most common reason for coronary bypass graft procedures. Today, there are multiple surgical and percutaneous approaches to treat coronary artery disease. Most recent evidence suggest that drug-eluting stents (DES) are an effective means to prevent recurrence after coronary artery disease treatment.

Unverified Answer

What is percutaneous mitral valve repair?

Add answer

In the treatment of rheumatic valve disease, PMVR is the definitive procedure, providing excellent short-term and long-term results in the appropriately selected patient population. The indications for PMVR should be expanded by more stringent application of accepted indications and clinical practice guidelines.

Unverified Answer

What is the average age someone gets coronary artery disease?

Add answer

Age of diagnosis of an incident case of CAD is about 57 years old. This is similar to CAD diagnoses observed among patients from a general internal medicine ward.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Coronary Artery Disease by sharing your contact details with the study coordinator.