ClinicalTrials.Veeva

Menu

LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY

U

University of Ottawa Heart Institute

Status

Not yet enrolling

Conditions

Mitral Valve Disease
Mitral Regurgitation
Heart Failure

Treatments

Other: Mitral valve repair with creation of an 8 mm inter-atrial shunt

Study type

Interventional

Funder types

Other

Identifiers

NCT06547788
20240059

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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+

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Mitral valve repair with creation of an 8m inter-atrial shunt
Experimental group
Treatment:
Other: Mitral valve repair with creation of an 8 mm inter-atrial shunt
Mitral valve repair without a shunt
Active Comparator group
Treatment:
Other: Mitral valve repair with creation of an 8 mm inter-atrial shunt

Trial contacts and locations

1

Loading...

Central trial contact

Alice Black; Kenza Rahmouni El Idrissi, Dr.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems