40 Participants Needed

Symptom Assessment for Mitral Valve Regurgitation

MD
Overseen ByMedical Director, Cardiovascular Imaging, MD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Atlantic Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the link between symptoms and the severity of mitral regurgitation (MR), a heart condition where blood leaks backward through the mitral valve. It examines how heart stiffness (diastolic dysfunction) might cause symptoms in people with MR. Participants will undergo heart tests before any surgery or valve repair. This study suits those with primary MR, normal heart pumping ability, and the ability to exercise on a treadmill. As an unphased trial, it offers participants the chance to contribute to understanding MR and its symptoms, potentially improving future treatments.

Why are researchers excited about this trial?

Researchers are excited about the study of mitral regurgitation in the context of left heart catheterization because it offers a unique approach to understanding this condition before mitral valve surgery or mitral valve clip procedures. Unlike existing treatments that focus on managing symptoms or surgically repairing the valve, this trial aims to assess the severity of mitral regurgitation directly through catheterization. This method could provide more precise information about the condition, potentially leading to more tailored and effective treatment plans for patients. By pinpointing the relationship between symptoms and severity, it may enhance decision-making in clinical care and improve outcomes for those undergoing mitral valve interventions.

Are You a Good Fit for This Trial?

Inclusion Criteria

My heart condition is due to primary mitral regurgitation.
I can exercise on a treadmill.
I can understand and agree to the study's details.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Participants undergo CMR, CPET, and KCCQ testing to assess mitral regurgitation severity, exercise capacity, and symptom burden

8 weeks
Multiple visits for testing

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Mitral RegurgitationExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Atlantic Health System

Lead Sponsor

Trials
58
Recruited
9,400+