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Mitral RegurgitationNCT06675448

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

An observational study of Mitral Regurgitation and Valvular Heart Disease, run by Inova Health Care Services at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
MitraClip and Moderate MR
Type of treatment
Medical device
How many people
33 participants
Where
1 siteUnited States
Study dates
28 Jan 2021to 18 Aug 2026
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population for this study include adult patients > 18 years of age who have symptomatic (NYHA class II-IVa) HFreF due to ischemic or idiopathic dilated cardiomyopathy (LV ejection fraction ≤ 50%), moderate (2+) to severe (4+) secondary MR and either at least 1 HF hospitalization within the prior 12 months or an elevated brain natriuretic peptide (BNP≥300) or N-terminal pro b-type natriuretic peptide (NT-proBNP ≥ 1500) and have been determined by the site's local heart team as not being appropriate for MV surgery. This study population is similar to patients enrolled in COAPT, but includes patients who present with moderate 2+ MR and others who may end up needing only optimal GDMT and/or CRT or Cardiomems.

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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)
Show all 31Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

Other trials in United States

About this study

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

Read the detailed description

All patients passing through the IHFTA will be tracked and followed w.r.t. their final therapies. Monthly meetings will occur with the IHFTA research team to assess and discuss any challenges in implementing the protocol. Impediments will be identified, and strategies put forth to address them. To examine whether the Inova IHFTA identifies the patient most likely to benefit from Mitraclip, the baseline clinical and echocardiographic characteristics of patients treated with Mitraclip within the IHFTA (who would have met the criteria for COAPT study) will be compared to those of the treated cohort in the COAPT trial using t-tests and Chi-squared tests

Being tested
MitraClip, Moderate MR
Medical subject headings
Mitral Valve Insufficiency, Heart Valve Diseases, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MitraClipDevice

    Also called MitraClip™ System

    Participants will undergo the Mitraclip procedure according to current standards of practice

  • Moderate MROther

    Patients who present with moderate MR (Mitral regurgitation) will serve also as an internal control against which the outcomes of Mitraclip treated patients)

Study groups in NCT06675448
Study groupRoleWhat they receive
Moderate MRPatients who present with moderate MR and remain in this state will be re-evaluated at 6 months by a phone call and EMR review for ConComitant Cardiac Medication Review, NYHA Class and Adverse Event Evaluation. At 12 months a follow-up evaluation that will include a review of medications, NYHA class, KCCQ, 6MWT, BNP, Adverse Event review and TTE.
Receives: Other: Moderate MR
MitraclipFor patient who undergo Mitraclip, the safety and effectiveness of the procedure will be evaluated and all peri-procedural complications recorded using the same definitions for procedural success and complications used in the COAPT trial
Receives: Device: MitraClip

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in NYHA from baseline to 6 months in patients who undergo Mitraclip

    There are 4 levels of NYHA:

    I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.

    II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.

    III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.

    IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III).

    Measured: baseline to 6 months post Mitraclip procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2024
  2. Study start28 Jan 2021
  3. Primary completion18 Aug 2026
  4. Study completion18 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
33 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06675448
Sponsor's protocol ID
U20-09-4258
Status last verified
Aug 2026
First submitted
4 Nov 2024
Last updated
1 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8.

    PubMed 16980116

  • Rossi A, Dini FL, Faggiano P, Agricola E, Cicoira M, Frattini S, Simioniuc A, Gullace M, Ghio S, Enriquez-Sarano M, Temporelli PL. Independent prognostic value of functional mitral regurgitation in patients with heart failure. A quantitative analysis of 1256 patients with ischaemic and non-ischaemic dilated cardiomyopathy. Heart. 2011 Oct;97(20):1675-80. doi: 10.1136/hrt.2011.225789. Epub 2011 Jul 31.

    PubMed 21807656

  • Hayashi S, Fushimi H. [Shock and lymphatic circulation]. Nihon Rinsho. 1970 Jan;28(1):84-9. No abstract available. Japanese.

    PubMed 4908819

  • Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ; COAPT Investigators. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.

    PubMed 30280640

  • Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27.

    PubMed 30145927

  • Yurewicz EC, Sacco AG, Subramanian MG. Pathways to immunocontraception: biochemical and immunological properties of glycoprotein antigens of the porcine zona pellucida. Adv Exp Med Biol. 1986;207:407-27. doi: 10.1007/978-1-4613-2255-9_22.

    PubMed 3825685

  • Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.

    PubMed 26673558

  • Sahyoun NR, Lentzner H, Hoyert D, Robinson KN. Trends in causes of death among the elderly. Aging Trends. 2001 Mar;(1):1-10. doi: 10.1037/e620692007-001. No abstract available.

    PubMed 11894224

  • Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.

    PubMed 23747642

  • Larson SL. Trophoblastic disease. Minn Med. 1967 Jan;50(1):81-6. No abstract available.

    PubMed 4292097

  • Golander A, Spirer Z, Bogair N, Konforti N. [Mima polymorpha bacteremia]. Harefuah. 1973 Sep 2;85(5):220-1. No abstract available. Hebrew.

    PubMed 4755414

  • McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.

    PubMed 25176015

  • Mack MJ, Abraham WT, Lindenfeld J, Bolling SF, Feldman TE, Grayburn PA, Kapadia SR, McCarthy PM, Lim DS, Udelson JE, Zile MR, Gammie JS, Gillinov AM, Glower DD, Heimansohn DA, Suri RM, Ellis JT, Shu Y, Kar S, Weissman NJ, Stone GW. Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial. Am Heart J. 2018 Nov;205:1-11. doi: 10.1016/j.ahj.2018.07.021. Epub 2018 Aug 1.

    PubMed 30134187

  • Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.

    PubMed 10758967

  • Callaghan P, Brodie J. Laboratory investigation of sewer swabs following the Aberdeen typhoid outbreak of 1964. J Hyg (Lond). 1968 Dec;66(4):489-97. doi: 10.1017/s0022172400028230. No abstract available.

    PubMed 4885562

Questions about this trial

What is this clinical trial studying?

An observational study of Mitral Regurgitation and Valvular Heart Disease, run by Inova Health Care Services at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in NYHA from baseline to 6 months in patients who undergo Mitraclip (time frame: baseline to 6 months post Mitraclip procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06675448, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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