Actively Recruiting
In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: An Evaluation of the Inova Heart Failure Treatment Algorithm
Led by Inova Health Care Services · Updated on 2025-12-03
50
Participants Needed
1
Research Sites
501 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The overarching goal of this research proposal is to study the feasibility and clinical impact of implementing an Inova system-wide heart failure treatment algorithm for patients with symptomatic heart failure due to reduced left ventricular ejection fraction (HFreF) and secondary MR Aim is to check the effectiveness of the IHFTA in identifying patients who are most likely to benefit from percutaneous transcatheter Mitraclip repair in real world
CONDITIONS
Official Title
In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: An Evaluation of the Inova Heart Failure Treatment Algorithm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic mitral regurgitation (grade 2 or higher) due to ischemic or nonischemic cardiomyopathy
- Adequately treated for coronary artery disease, left ventricular dysfunction, mitral regurgitation, and heart failure
- New York Heart Association (NYHA) functional class II, III, or ambulatory IV
- Local heart team has decided mitral valve surgery will not be offered even if assigned to control group
- Left ventricular ejection fraction (LVEF) 50% or less
- Left ventricular end-systolic diameter (LVESD) 70 mm or less
- MitraClip implanting investigator believes primary regurgitant jet can be treated by MitraClip
- Transseptal catheterization and femoral vein access are feasible according to MitraClip implanting investigator
- Age 18 years or older
- Participant or guardian agrees to all study protocol provisions
- NT-proBNP 1500 ng/ml or higher, or BNP 300 ng/ml or higher
You will not qualify if you...
- Untreated clinically significant coronary artery disease requiring revascularization
- Coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or transcatheter aortic valve replacement (TAVR) within the past 30 days
- Aortic or tricuspid valve disease requiring surgery or transcatheter intervention
- Chronic obstructive pulmonary disease (COPD) needing continuous home oxygen or chronic oral steroids
- Stroke within the past 30 days
- Severe symptomatic carotid artery narrowing (greater than 70% by ultrasound)
- Carotid surgery or stenting within the past 30 days
- Stage D heart failure according to ACC/AHA classification
- High pulmonary artery systolic pressure (greater than 70 mm Hg), unless reduced by vasodilator therapy
- Hypertrophic, restrictive, or constrictive cardiomyopathy, or other non-dilated structural heart diseases causing heart failure
- Infiltrative cardiomyopathies like amyloidosis, hemochromatosis, or sarcoidosis
- Hemodynamic instability requiring inotropic support or mechanical heart assistance
- Right-sided heart failure with moderate or severe right ventricular dysfunction
- Cardiac resynchronization therapy (CRT) or CRT-defibrillator implanted within last 30 days
- Mitral valve orifice area less than 4.0 cm2
- Leaflet anatomy unsuitable for MitraClip implantation or effective MR reduction
- Persistent low blood pressure below 90 mm Hg or cardiogenic shock
- Need for urgent or planned cardiac surgery within next 12 months
- Life expectancy less than 12 months due to non-cardiac causes
- Conditions limiting participation as judged by investigators
- Status 1 heart transplant or previous orthotopic heart transplant
- Previous mitral valve leaflet surgery, prosthetic mitral valve, or prior transcatheter mitral valve procedure
- Intracardiac mass, thrombus, or vegetation seen on echocardiogram
- Active endocarditis, rheumatic heart disease, or damaged leaflets from rheumatic disease
- Active infections requiring antibiotics
- Contraindication or high risk for transesophageal echocardiogram (TEE)
- Known allergy or contraindication to procedural medications that cannot be medically managed
- Pregnant or planning pregnancy within next 12 months
- Currently participating in another investigational drug or device study not completed
- Belongs to a vulnerable population or unable to give informed consent or follow study procedures
AI-Screening
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Trial Site Locations
Total: 1 location
1
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Actively Recruiting
Research Team
H
Hassan Saeed
CONTACT
M
Mahira Awan
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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