Status:
NOT_YET_RECRUITING
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
Mitral Regurgitation
Mitral Valve Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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. Pat...
Eligibility Criteria
Inclusion
- 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
- 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+
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06547788
Start Date
September 30 2024
End Date
January 31 2030
Last Update
August 9 2024
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7