Mitral Valve Repair for Mitral Valve Regurgitation

(LAMBDA Trial)

Overseen By Kenza Rahmouni El Idrissi, Dr.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Secondary MR, Endocarditis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery and immediate recovery

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Mitral valve repair with creation of an 8 mm inter-atrial shunt for Mitral Valve Regurgitation?

Mitral valve repair is widely recognized as an effective treatment for mitral valve regurgitation, with studies showing it is often preferred over replacement due to better outcomes. The procedure has been shown to result in low rates of complications and high survival rates, especially in cases of degenerative disease. ^{1 2 3 4 5}

Is mitral valve repair generally safe for humans?

Mitral valve repair, including the MitraClip device, has been shown to be generally safe in humans, with studies indicating lower operative mortality compared to replacement and good safety outcomes in high-risk patients. However, some complications can occur, and more high-quality studies are needed to confirm these findings. ^{6 7 8 9 10}

How does the treatment of mitral valve repair with an 8 mm inter-atrial shunt differ from other treatments for mitral valve regurgitation?

This treatment is unique because it combines mitral valve repair with the creation of an 8 mm inter-atrial shunt, which is not a standard component of traditional mitral valve repair procedures. The shunt may help manage pressure differences between the heart's chambers, potentially offering benefits not seen with standard repair alone. ^{1 2 3 5 11}

What is the purpose of this trial?

Mitral valve leakage, or mitral regurgitation (MR), is associated with heart failure symptoms including shortness of breath, fatigue, irregular heart rate. When left untreated, it may cause death. Patients with MR can be divided in two broad groups: those with primary MR, caused by disease of the mitral valve structures, and those with secondary MR, due to dilation of the heart chambers. Our study focuses on patients with primary MR. The standard treatment for severe symptomatic primary MR is mitral valve surgery, a type of open-heart surgery. The outcomes following this procedure are excellent, however, a subset of patients continue to experience heart failure symptoms after surgery due to very high pressures in the heart, more specifically in the left atrium, which is one of the four heart chambers. This is called functional mitral stenosis (FMS). Previous studies have shown that creating a small opening between the left and right atria can help relieve the pressure inside the left atrium. We would like to determine whether creating this opening between the two atria at the time of mitral valve surgery can help prevent FMS. To answer this question, we will study two groups of patients who need mitral valve surgery for primary MR. The first group will undergo mitral valve surgery, along with the creation of the opening between the two atria. The second group will undergo mitral valve surgery alone. We will then compare the outcomes between both groups, namely with regards to their heart failure symptoms after open-heart surgery.

Research Team

Vincent Chan, Dr.

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

This trial is for patients with primary mitral valve regurgitation, a heart condition causing symptoms like breathlessness and irregular heartbeat. Participants must need mitral valve surgery but cannot have other conditions that might complicate the procedure or recovery.

Inclusion Criteria

Right-to-left atrial pressure gradient ≥ 5 mmHg at baseline

Pulmonary vascular resistance ≤ 4 Wood units

I have severe valve leakage due to a degenerative condition.

Exclusion Criteria

My heart condition involves secondary causes of mitral regurgitation and mixed mitral valve disease.

I have not had infective endocarditis in the last 30 days.

Any prior mitral valve intervention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mitral valve surgery, with one group receiving an additional inter-atrial shunt procedure

Surgery and immediate recovery

Follow-up

Participants are monitored for heart failure symptoms and other outcomes after surgery

30 months

Treatment Details

Interventions

• Mitral valve repair with creation of an 8 mm inter-atrial shunt

Trial Overview The study tests if creating an 8 mm hole between the left and right atria during standard mitral valve repair surgery can prevent high pressures in the heart and reduce post-surgery heart failure symptoms compared to surgery alone.

Participant Groups

Group I: Mitral valve repair with creation of an 8m inter-atrial shunt Experimental Treatment 1 Intervention

Group II: Mitral valve repair without a shunt Active Control 1 Intervention

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Findings from Research

In a study of 86 patients undergoing mitral valve repair, intraoperative transoesophageal echocardiography (TOE) was found to be the most sensitive method for detecting residual mitral regurgitation, identifying successful repairs in 87% of cases.

Despite saline testing indicating successful repairs, TOE revealed significant residual regurgitation in 8.2% of patients, leading to necessary interventions such as valve replacement or revision, highlighting the importance of accurate intraoperative imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of mitral valve repair by intraoperative transoesophageal echocardiography. Kalman, JM., Jones, EF., Lubicz, S., et al.[2019]

In a study of 107 patients undergoing mitral valve repair with the MitraClip device, successful treatment led to a significant increase in cardiac output (CO) from 5.0 to 5.7 l/min and forward stroke volume (FSV) from 57 to 65 ml, indicating improved heart function immediately after the procedure.

The MitraClip procedure also resulted in reduced left ventricular (LV) pressure and volume, with no patients experiencing a low cardiac output state post-treatment, suggesting that this method may be safer than traditional surgical options for mitral regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The acute hemodynamic effects of MitraClip therapy. Siegel, RJ., Biner, S., Rafique, AM., et al.[2022]

The MitraClip Transcatheter Mitral Valve Repair system has been shown to be safe and effective for treating symptomatic degenerative mitral regurgitation in high-risk patients, with over 4,000 patients treated in the U.S. and more than 35,000 worldwide since its approval in 2013.

Real-world data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry indicate that the MitraClip may be even safer and more effective than results from initial clinical trials, highlighting its potential for broader use in various patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Repair of Mitral Regurgitation. Barker, CM.[2019]

References

1. Japan pubmed.ncbi.nlm.nih.gov

The effect of pathophysiology on the outcome of mitral valve repair for mitral regurgitation. [2016]

2. Turkey pubmed.ncbi.nlm.nih.gov

Clinical outcomes of mitral valve repair in mitral regurgitation: a prospective analysis of 100 consecutive patients. [2016]

3. Australia pubmed.ncbi.nlm.nih.gov

Evaluation of mitral valve repair by intraoperative transoesophageal echocardiography. [2019]

4. Portugal pubmed.ncbi.nlm.nih.gov

Mid-term outcomes of mitral valve repair in a low-volume hospital. [2019]

5. Chile pubmed.ncbi.nlm.nih.gov

[Long-term results of repair versus replacement for degenerative mitral valve regurgitation]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Acute iatrogenic complications after mitral valve repair. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The acute hemodynamic effects of MitraClip therapy. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Comparison of Outcomes following Mitral Valve Repair versus Replacement for Chronic Ischemic Mitral Regurgitation: A Meta-Analysis. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Repair of Mitral Regurgitation. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Safety and efficacy outcomes at 1 year after MitraClip therapy for percutaneous mitral valve repair in patients with severe mitral regurgitation: the Egyptian experience. [2021]

11. Iran pubmed.ncbi.nlm.nih.gov

Mitral valve repair: the chordae tendineae. [2022]