Left atrial shunt to help after mitral valve surgery
Official title: LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Run by Ottawa Heart Institute Research Corporation · NCT06547788 · Data updated 2026-11-12
This study tests whether making a small opening between the left and right atria during mitral valve repair can relieve high left atrial pressure for adults with primary mitral regurgitation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Status | Recruiting |
| Started | December 19, 2024 |
| Main results expected | January 31, 2028 |
| Study ends | January 31, 2030 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT06547788 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with severe primary (degenerative) mitral regurgitation planned for mitral valve repair and a baseline right-to-left atrial pressure gradient ≥ 5 mmHg.
✕Probably not a fit
Patients with secondary MR, prior mitral valve interventions, or very low expected left ventricular function may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with severe primary mitral regurgitation scheduled for mitral valve repair will receive an 8 mm inter-atrial shunt in addition to surgery. The goal is to see if this shunt lowers left atrial pressure and improves post-surgical symptoms. The trial focuses on patients with high baseline right-to-left atrial pressure gradients and excludes those with secondary MR or prior mitral interventions. Outcomes will include hemodynamic measures and clinical status after surgery. This is a single-site interventional study led by the Ottawa Heart Institute Research Corporation.
Why it matters
Potential benefit: If successful, patients may experience reduced left atrial pressure and improved heart failure symptoms after mitral valve surgery.
How similar studies have gone: Previous work suggests atrial shunts can relieve atrial pressures, but evidence in this exact perioperative setting is limited.
Who can join: the full rules
Show full inclusion / exclusion 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+
Where it's running
-
University of Ottawa Heart Institute
Ottawa, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Vincent Chan, Dr. — Ottawa Heart Institute Research Corporation
- Study coordinator: Kenza Rahmouni El Idrissi, Dr.
- Email: krahmouni@ottawaheart.ca
- Phone: 613-696-7000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.