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Clinical Trials/NCT06547788
NCT06547788
Not Yet Recruiting
N/A

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

Ottawa Heart Institute Research Corporation1 site in 1 country50 target enrollmentSeptember 30, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mitral Regurgitation
Sponsor
Ottawa Heart Institute Research Corporation
Enrollment
50
Locations
1
Primary Endpoint
Feasibility: Study follow-up rate and length
Status
Not Yet Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 30, 2024
End Date
January 31, 2030
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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+

Outcomes

Primary Outcomes

Feasibility: Study follow-up rate and length

Time Frame: 30 Months

Process, Resources, Management, Scientific

Feasibility: recruitment rate

Time Frame: 30 Months

Process, Resources, Management, Scientific

Feasibility: Success rate of intervention

Time Frame: 30 Months

Process, Resources, Management, Scientific

Study Sites (1)

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