NCT06675448 In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: An Evaluation of the Inova Heart Failure Treatment Algorithm
| NCT ID | NCT06675448 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Inova Health Care Services |
| Condition | Mitral Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-01-28 |
| Primary Completion | 2029-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2021-01-28 with a primary completion date of 2029-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * Symptomatic MR (≥2+) due to cardiomyopathy of either ischemic or nonischemic etiology * Subject has been adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, MR, and HF. * NYHA functional class II, III, or ambulatory IV * Local heart team has determined that MV surgery will not be offered as a treatment option even if the subject is randomized to the Control group. * LVEF ≤50%. * LVESD ≤70 mm * The primary regurgitant jet , in the opinion of the MitraClip implanting investigator, can be successfully treated by the MitraClip (if a secondary jet exists, it must be considered clinically insignificant). * Transseptal catheterization and femoral vein access is feasible per the MitraClip implanting investigator. * Age 18 y or older * Subject or guardian agrees to all provisions of the protocol * NT-proBNP≥ 1500ng/ml or BNP≥ 300ng/ml Exclusion Criteria: * Untreated clinically significant coronary artery disease requiring revascularization * CABG, PCI, or TAVR within the prior 30 d * Aortic or tricuspid valve disease requiring surgery or transcatheter intervention * COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use * Cerebrovascular accident within prior 30 d * Severe symptomatic carotid stenosis (N70% by ultrasound) * Carotid surgery or stenting within prior 30 d * ACC/AHA stage D HF * Presence of any of the following: * Estimated PASP N70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the catheterization laboratory is able to reduce the PVR to b3 Wood units or between 3 and 4.5 Wood units with v wave less than twice the mean of the PCWP * Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing HF other than dilated cardiomyopathy of either ischemic or nonischemic etiology * Infiltrative cardiomyopathies (eg, amyloidosis, hemochromatosis, sarcoidosis) * Hemodynamic instability requiring inotropic support or mechanical heart assistance * Physical evidence of right-sided congestive HF with echocardiographic evidence of moderate or severe right ventricular dysfunction * Implant of CRT or CRT-D within the last 30 d * Mitral valve orifice area \<4.0 cm2 by site-assessed TTE * Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets, or sufficient reduction in MR by the MitraClip * Hemodynamic instability defined as persistent systolic pressure \<90 mm Hg with or without afterload reduction, cardiogenic shock, or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device * Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 m * Life expectancy \<12 m due to noncardiac conditions * Investigators opinion a condition that could limit the subject's participation * Status 1 heart transplant or prior orthotopic heart transplantation * Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure * Echocardiographic evidence of intracardiac mass, thrombus, or vegetation * Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (ie, noncompliant, perforated) * Active infections requiring current antibiotic therapy * TEE is contraindicated or high risk * Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically * Pregnant or planning pregnancy within next 12m * Currently participating in an investigational drug or another device study that has not reached its primary end point * Subject belongs to a vulnerable population or has any disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures.
Contact & Investigator
Matthew Sherwood, MD
PRINCIPAL INVESTIGATOR
Inova Health Care Services
Frequently Asked Questions
Who can join the NCT06675448 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06675448 currently recruiting?
Yes, NCT06675448 is actively recruiting participants. Contact the research team at hassan.saeed@inova.org for enrollment information.
Where is the NCT06675448 trial being conducted?
This trial is being conducted at Falls Church, United States.
Who is sponsoring the NCT06675448 clinical trial?
NCT06675448 is sponsored by Inova Health Care Services. The principal investigator is Matthew Sherwood, MD at Inova Health Care Services. The trial plans to enroll 50 participants.