LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY (NCT06547788)
π©Ί Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Ottawa Heart Institute β Ottawa, Ontario
Age range: 18 Years
π§ͺ Interventions in This Study
- Mitral valve repair with creation of an 8 mm inter-atrial shunt (OTHER)
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (1 Sites)
- University of Ottawa Heart Institute β Ottawa, Ontario
π Contact the Study Coordinator
Phone: (613) 696-7000
Email: krahmouni@ottawaheart.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Mitral Regurgitation
- Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation β Birmingham, Alabama
- SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation β Los Angeles, California
- Beating Heart Mitral Valve Repair With the HARPOONβ’ System β San Francisco, California
- Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation β Ottawa, Ontario
- CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry β Tucson, Arizona
Explore by condition: All Mitral Regurgitation clinical trials
π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.