Mitral RegurgitationLAMBDANCT06547788
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
A study testing Mitral valve repair with creation of an 8 mm inter-atrial shunt in people with Mitral Regurgitation and Mitral Valve Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Mitral Valve Disease, Heart Failure
- What is being tested?
- Mitral valve repair with creation of an 8 mm inter-atrial shunt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2026to 31 Jan 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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+
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Kenza Rahmouni, Dr., krahmouni@ottawaheart.ca
Alice Black, 613-696-7230, alblack@ottawaheart.ca
About this study
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.
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Heart Failure
- Being tested
- Mitral valve repair with creation of an 8 mm inter-atrial shunt
- Medical subject headings
- Mitral Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve repair with creation of an 8 mm inter-atrial shuntOther
Mitral valve repair with creation of an 8 mm inter-atrial shunt
| Study group | Role | What they receive |
|---|---|---|
| Mitral valve repair with creation of an 8m inter-atrial shunt | Experimental | Not described Receives: Other: Mitral valve repair with creation of an 8 mm inter-atrial shunt |
| Mitral valve repair without a shunt | Active comparator | Not described Receives: Other: Mitral valve repair with creation of an 8 mm inter-atrial shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: recruitment rate
Process, Resources, Management, Scientific
Measured: 30 Months
Feasibility: Success rate of intervention
Process, Resources, Management, Scientific
Measured: 30 Months
Feasibility: Study follow-up rate and length
Process, Resources, Management, Scientific
Measured: 30 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start30 Sep 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Chan, Dr., Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547788
- Sponsor's protocol ID
- 20240059
- Acronym
- LAMBDA
- Status last verified
- Apr 2026
- First submitted
- 7 Aug 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No