NCT06547788 LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
| NCT ID | NCT06547788 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Mitral Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-12-19 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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+
Contact & Investigator
Vincent Chan, Dr.
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT06547788 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06547788 currently recruiting?
Yes, NCT06547788 is actively recruiting participants. Contact the research team at krahmouni@ottawaheart.ca for enrollment information.
Where is the NCT06547788 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT06547788 clinical trial?
NCT06547788 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Vincent Chan, Dr. at Ottawa Heart Institute Research Corporation. The trial plans to enroll 50 participants.