Recruiting

Mitral Valve Surgery vs. Mitral Valve Surgery with Atrial Opening

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT06547788

Conditions

Mitral Regurgitation

Mitral Valve Disease

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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. 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

Study ID

NCT06547788

Start date

Dec 19, 2024

Status verified date

Nov, 2026

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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+

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mitral valve repair with creation of an 8m inter-atrial shunt

active comparator: Mitral valve repair without a shunt

Interventions

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

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

Primary outcome measure

  • Feasibility: recruitment rate [ Time Frame: 30 Months ]
  • Feasibility: Success rate of intervention [ Time Frame: 30 Months ]
  • Feasibility: Study follow-up rate and length [ Time Frame: 30 Months ]

Central Contacts and Locations

Central contacts

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Nov 5, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.