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
- 19 Dec 2024to 31 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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, 1 recruiting
- Recruiting
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 start19 Dec 2024
- 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.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- 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
- Nov 2026
- First submitted
- 7 Aug 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
- ClinicalTrials.gov ID
- NCT06547788
- Acronym / sponsor ID
- LAMBDA / 20240059
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitral valve repair with creation of an 8m inter-atrial shunt | Experimental | Other: Mitral valve repair with creation of an 8 mm inter-atrial shunt |
| Mitral valve repair without a shunt | Active comparator | Other: Mitral valve repair with creation of an 8 mm inter-atrial shunt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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+
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitral valve repair with creation of an 8 mm inter-atrial shuntMitral valve repair with creation of an 8 mm inter-atrial shunt | Other | Mitral valve repair with creation of an 8m inter-atrial shunt, Mitral valve repair without a shunt |
Primary outcome
Feasibility: recruitment rate
Time frame: 30 Months
Process, Resources, Management, Scientific
Feasibility: Success rate of intervention
Time frame: 30 Months
Process, Resources, Management, Scientific
Feasibility: Study follow-up rate and length
Time frame: 30 Months
Process, Resources, Management, Scientific
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent Chan, Dr. principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenza Rahmouni El Idrissi, Dr. (613-696-7000, krahmouni@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: recruitment rate (time frame: 30 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.