RECRUITING

In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: An Evaluation of the Inova Heart Failure Treatment Algorithm

Conditions

Mitral Regurgitation Valvular Heart Disease Heart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2021-01-28

Study Completion:2030-09-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06675448

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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, including the possibility of randomization to the Control group and returning for all required postprocedure follow-up visits, and has provided written informed consent	* 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 * Modified Rankin Scale ≥4 disability * 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.

Inclusion Criteria

Exclusion 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, including the possibility of randomization to the Control group and returning for all required postprocedure follow-up visits, and has provided written informed consent

* 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
* Modified Rankin Scale ≥4 disability
* 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.

Contacts and Locations

Study Contact

Hassan Saeed

CONTACT

(703) 776-5716

hassan.saeed@inova.org

Mahira Awan

CONTACT

(703) 776-5716

mahira.awan@inova.org

Principal Investigator

Wayne Batchelor, MD

PRINCIPAL_INVESTIGATOR

Inova Health Care Services

Study Locations (Sites)

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042

United States

Collaborators and Investigators

Sponsor: Inova Health Care Services

Wayne Batchelor, MD, PRINCIPAL_INVESTIGATOR, Inova Health Care Services

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-28

Study Completion Date2030-09-10

Study Record Updates

Study Start Date2021-01-28

Study Completion Date2030-09-10

Terms related to this study

Additional Relevant MeSH Terms

Mitral Regurgitation
Valvular Heart Disease
Heart Failure