Treatment Algorithm for Mitral Valve Regurgitation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Mixed mitral pathology, acute IMR

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery and immediate recovery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to determine whether patients with severe ischemic mitral valve regurgitation (a leaky heart valve due to heart muscle changes) should undergo valve repair or replacement. Typically, surgeons base this decision on personal preference or experience. However, this study employs an algorithm, a set of guidelines, based on specific heart measurements. The goal is to assess whether the algorithm leads to better patient outcomes compared to the current approach. Individuals with severe ischemic mitral valve regurgitation who can provide informed consent may qualify for this study. Researchers will monitor participants for a year after surgery to evaluate which approach proves more effective. As an unphased trial, this study allows patients to contribute to innovative research that could enhance decision-making in heart valve treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this treatment algorithm is safe for mitral valve regurgitation?

Research has shown that mitral valve surgeries, such as repair or replacement, are generally well-tolerated. Previous studies indicate that these surgeries can improve symptoms and extend patients' lives. For instance, real-world data demonstrates that using the MitraClip to repair the mitral valve is safe during hospital stays.

When choosing between repair or replacement, it is important to recognize the long-standing safety record of these surgeries. The goal is to reduce complications and enhance quality of life. Although the specific method being tested may lack extensive data, the surgeries themselves are well-established and have proven safe in many cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new protocol for deciding how to treat mitral valve regurgitation based on the posterior leaflet tethering angle. Unlike the standard practice, where the decision to repair or replace the valve is left to the surgeon's discretion, this method uses a specific angle measurement to guide treatment. This could lead to more personalized and potentially more effective outcomes by tailoring the intervention to the patient's unique anatomical features.

What evidence suggests that this trial's treatments could be effective for ischemic mitral regurgitation?

This trial compares two approaches for treating mitral valve regurgitation. Research has shown that using a specific method to decide whether to repair or replace the mitral valve can improve patient outcomes. In the treatment algorithm arm of this trial, surgery is guided by measuring the angle of a part of the mitral valve to select the best surgical option. This personalized approach aims to match the treatment to the patient's heart condition, potentially leading to better recovery and heart function. Advances in diagnostic tools and strategies have made this personalized treatment more practical and effective. Meanwhile, in the no treatment algorithm arm, the surgeon decides whether to repair or replace the mitral valve at their discretion. ^{6 7 8 9 10}

Who Is on the Research Team?

Vincent Chan, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

I have a mixed condition affecting my mitral valve.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mitral valve repair or replacement based on either surgeon's discretion or an algorithm

Surgery and immediate recovery

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• No Treatment Algorithm
• Treatment Algorithm

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment algorithm Experimental Treatment 1 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 algorithm Active Control 1 Intervention

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

Treatment Algorithm is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ketalar for:

• Anesthesia
• Pain management
• Sedation

Approved in European Union as Ketalar for:

• Anesthesia
• Pain management
• Sedation

Approved in Canada as Ketalar for:

• Anesthesia
• Pain management
• Sedation

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12387918/

Treatment Strategies for Patients with Mitral Regurgitation Current TMVR strategies can be broadly classified into transcatheter edge-to-edge repair (TEER, MitraClip [Abbott Vascular] and Pascal [Edwards ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.125.074560

Long-Term Outcomes of Early Surgery Versus ... Surgery is recommended for severe, degenerative mitral regurgitation (MR) in symptomatic and asymptomatic patients with left ventricular (LV) ...

3. acc.org acc.org/Latest-in-Cardiology/Articles/2025/06/02/12/24/Advancing-the-Management-of-Mitral-Regurgitation

Advancing the Management of Mitral Regurgitation: A New ... Management of MR is progressing due to advances in transcatheter therapies, AI-driven diagnostics, and earlier intervention strategies. As TEER ...

4. emedicine.medscape.com emedicine.medscape.com/article/155618-treatment

Mitral Regurgitation Treatment & Management Surgery is recommended for moderate to severe (grade >3) mitral regurgitation (MR) in symptomatic patients or those with left ventricular (LV) dysfunction.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00807040

NCT00807040 | Comparing the Effectiveness of Repairing ... Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Regurgitation. Conditions. Mitral Valve Insufficiency ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000000923

2020 ACC/AHA Guideline for the Management of Patients ... The purpose of valvular intervention is to improve symptoms, prolong survival, and minimize the risk of VHD-related complications, such as ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9725093/

2021 ESC/EACTS Guidelines for the management of valvular ... Association between early surgical intervention vs watchful waiting and outcomes for mitral regurgitation due to flail mitral valve leaflets. JAMA. 2013;310 ...

8. eurointervention.pcronline.com eurointervention.pcronline.com/article/incidence-and-in-hospital-safety-outcomes-of-patients-undergoing-percutaneous-mitral-valve-edge-to-edge-repair-using-mitraclip-five-year-german-national-patient-sample-including-13575-implants

Incidence and in-hospital safety outcomes of patients ... Our data indicate that edge-to-edge mitral valve repair using the MitraClip technique has acceptable in-hospital safety outcomes in a real-world scenario.

9. jacc.org jacc.org/doi/10.1016/j.jacc.2020.02.005

2020 Focused Update of the 2017 ACC Expert Consensus ... Association between early surgical intervention vs watchful waiting and outcomes for mitral regurgitation due to flail mitral valve leaflets.

10. jtcvs.org jtcvs.org/article/S0022-5223(21)00592-4/fulltext

2020 ACC/AHA guideline for the management of patients ... The purpose of valvular intervention is to improve symptoms, prolong survival, and minimize the risk of VHD-related complications, such as ...