NCT06547788Not yet recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 7 Aug 2024
- Start date
- 30 Sept 2026
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Diseases
- Heart failure
- NCT number
- NCT06547788
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 30 Sept 2026 to the primary completion date, 31 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior mitral valve intervention
- Need for emergency intervention or surgery
Other illness
- Secondary causes of MR and mixed mitral valve disease
Lab values
- Left ventricular ejection fraction 2+
Other
- Infective endocarditis within 30-days
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.