LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY

Not Applicable

Not yet recruiting

• Conditions: Heart Failure; Mitral Regurgitation; Mitral Valve Disease
• Interventions: Other: Mitral valve repair with creation of an 8 mm inter-atrial shunt

• Registration Number: NCT06547788
• Lead Sponsor: Ottawa Heart Institute Research Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Study Start: 2024-09-30
• Primary Completion: 2028-01-31
• Study Completion: 2030-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients ≥18 years of age
• Severe (4+) symptomatic Carpentier Type II MR due to degenerative disease
• Planned surgical mitral valve repair
• Right-to-left atrial pressure gradient ≥ 5 mmHg at baseline
• Pulmonary vascular resistance ≤ 4 Wood units

Exclusion Criteria

• Secondary causes of MR and mixed mitral valve disease
• Infective endocarditis within 30-days
• Any prior mitral valve intervention
• Need for emergency intervention or surgery
• Left ventricular ejection fraction 2+

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitral valve repair with creation of an 8m inter-atrial shunt	Mitral valve repair with creation of an 8 mm inter-atrial shunt	-
Mitral valve repair without a shunt	Mitral valve repair with creation of an 8 mm inter-atrial shunt	-

Primary Outcome Measures

Name	Time	Method
Feasibility: Study follow-up rate and length	30 Months	Process, Resources, Management, Scientific
Feasibility: recruitment rate	30 Months	Process, Resources, Management, Scientific
Feasibility: Success rate of intervention	30 Months	Process, Resources, Management, Scientific

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada