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Treatment Algorithm for Mitral Valve Regurgitation

N/A

Waitlist Available

Led By Vincent Chan, MD

Research Sponsored by Ottawa Heart Institute Research Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Severe ischemic mitral valve regurgitation

Be older than 18 years old

Must not have

Mixed mitral valve pathology

Acute ischemic mitral regurgitation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months after surgery

Awards & highlights

No Placebo-Only Group

Summary

This trialtests if a specific method of deciding whether to repair or replace the mitral valve can improve outcomes in IMR.

Who is the study for?

This trial is for adults who can consent and have severe ischemic mitral valve regurgitation, a heart condition where the valve leaks due to coronary artery disease. It's not for those with mixed valve issues or acute cases of this condition.

What is being tested?

The study compares two approaches: one group gets standard care (valve repair/replacement based on surgeon choice), while the other follows a treatment algorithm deciding between repair or replacement based on specific measurements of the mitral valve.

What are the potential side effects?

Since this trial involves surgical procedures, potential side effects include typical surgery risks such as infection, bleeding, reactions to anesthesia, and complications related to heart surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe leakage in my heart's mitral valve due to poor blood supply.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a mixed condition affecting my mitral valve.

Select...

I have a heart valve issue due to a recent blockage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Left ventricle end-systolic volume indexed to body surface area

Secondary study objectives

Change in indexed left atrial volume

Change in right ventricle systolic pressure

Major adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment algorithmExperimental Treatment1 Intervention

Mitral valve will be replaced if posterior leaflet tethering angle \>=25 degrees. Mitral valve will be repaired if posterior leaflet tethering angle \<25 degrees

Group II: No treatment algorithmActive Control1 Intervention

Mitral valve will be repaired or replaced at surgeon's discretion.

0 / 3Eligibility criteria met