REPAIR MR TRIAL

This page is intended to provide clinical trial information only. The products and procedures discussed on this page are currently in clinical study and are not approved for commercial use. CAUTION: MitraClip (for REPAIR-MR indications) is an investigational device. Limited by Federal (U.S.) law to investigational use only

REPAIR MR TRIAL EXAMINES CLINICAL OUTCOMES OF MITRACLIP TMVr IN MODERATE-SURGICAL-RISK PMR PATIENTS

The REPAIR MR Trial (Percutaneous MitraClip™ Device or Surgical Mitral Valve REpair in PAtients with PrImaRy Mitral Regurgitation who are Candidates for Surgery) is now underway, and will be studying 500 patients at up to 60 medical centers in the United States, Canada, and Europe.

This clinical trial will study the MitraClip™ Transcatheter Mitral Valve Repair system in patients with severe primary mitral regurgitation who are at moderate surgical risk and whose mitral valve (MV) has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. The objective of this trial is to compare the clinical outcomes of the MitraClip device versus open surgical repair.

TRANSCATHETER MITRAL VALVE REPAIR

Transcatheter mitral valve repair is a less-invasive treatment option for patients who are deemed appropriate for this procedure. The procedure is done using the MitraClip Transcatheter Mitral Valve Repair system.

1. A guide catheter (a thin tube) will be inserted through a vein from a small cut in your upper leg to reach your heart.
 

2. The MitraClip implant, which is attached to the end of a Clip delivery system, will be guided to your mitral valve through the catheter.

3. The implant will be positioned and the Clip will grasp the mitral valve leaflets to close the center of the mitral valve and reduce MR.

4. Once the Clip is in place, it will be separated from the Clip delivery system.

 

5. Implanted Clip will become a permanent part of your heart, allowing your mitral valve to close more tightly and reduce the backward flow of blood.

ELIGIBILITY CRITERIA

KEY INCLUSION CRITERIA

Subjects must meet all of the following inclusion criteria in order to participate in the trial:

  • Subject has severe (Grade III or greater per the ASE criteria, which includes severity grades of 3+ and 4+) primary MR as assessed by the echocardiography core-lab (mixed etiology is acceptable provided the principal mechanism of action is due to degenerative mitral valve pathology)
  • The cardiac surgeon of the Site Heart Team (consisting of at least one interventionalist, and one cardiac surgeon) has confirmed that the subject is a candidate for mitral valve surgery and the eligibility committee (EC) has confirmed that the subject’s mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ device with high certainty of achieving MR ≤ mild
  • Subject is symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery systolic pressure > 50 mmHg, or LVESD > 40 mm
  • Subject is at least 75 years of age, OR if younger than 75 years, then has:
    • Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, or
    • Presence of other comorbidities which may introduce a potential surgery-specific impediment
  • Subject provides written informed consent
  • Subject is ≥ 18 years of age
     

KEY EXCLUSION CRITERIA

  • Subject is currently participating in another clinical investigation
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could limit the subject’s ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  • Subject has ischemic or non-ischemic secondary MR
  • Concomitant severe tricuspid valve regurgitation
  • Ejection fraction < 30%
  • Severe mitral annular calcification
  • Acute myocardial infarction in the past 12 weeks
  • Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease
  • Subjects who have concurrent coronary artery disease may be included provided the subjects are eligible for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery. Subjects randomized to the device group, must undergo PCI before the MitraClip procedure. Subjects randomized to the surgical (control) arm may undergo coronary artery revascularization during mitral valve repair surgery.
  • Surgical procedure performed in the past 30 days
  • Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere with the catheter or ipsilateral DVT
  • Transesophageal echocardiography (TEE) is contraindicated
  • Hemodynamic instability: systolic pressure ≤ 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or Intra-Aortic Balloon Pump (IABP)
  • Need for emergency surgery for any reason
  • Prior mitral valve surgery, valvuloplasty, mechanical prosthetic valve or Ventricular Assist Device (VAD)
  • Systolic anterior motion of the Mitral Valve
  • Hypertrophic cardiomyopathy
  • Renal insufficiency requiring dialysis
  • Active infections requiring current antibiotic therapy
  • Subjects who are pregnant or planning to be pregnant

REPAIR MR TRIAL DESIGN

This is a prospective, multi-center, randomized, controlled, clinical investigation of 500 subjects at 60 medical centers in the United States, Canada, and Europe.

Clinical follow-ups will be a combination of in-person and phone only follow-ups.

Clinical follow-ups will be a combination of in-person and phone only follow-ups.

CLINICAL TRIAL ENDPOINTS

CO-PRIMARY ENDPOINT #1

All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at 2 years (any cardiac hospitalizations in the first 30 days post treatment will be excluded)

CO-PRIMARY ENDPOINT #2

Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) from the time of index procedure through 2 years

SECONDARY ENDPOINTS
  • Proportion of subjects with MR ≤ mild (1+) at 30 days post-index procedure among survivors
  • Hospital length of stay from procedure to home discharge (days)
  • Proportion of subjects discharged to home post index hospitalization
  • Quality of life improvement assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) of at least 10 points at 2 years compared to baseline among survivors.
  • Severe Symptomatic mitral stenosis at 1 year

ABOUT MITRAL REGURGITATION

More lives are compromised by Mitral Regurgitation (MR) than any other valve disease. It is a progressive disease; if left untreated, it can lead to heart failure, or even death.2 MR is reported to have a 5-year mortality rate of 47%.3

Guideline-Directed Medical Therapy (GDMT) can be used to treat MR in certain patients. Certain beta-blockers and renin-angiotensin-aldosterone pathway inhibitors have been associated with reverse LV remodeling.4 In some patients, GDMT has been associated with diminished MR severity.5 However, data indicate that many patients go without recommended treatment because adherence to cardiology society guidelines is poor.6-8 In addition, the outlook for patients whose severe MR persists in spite of optimal medical therapy remains bleak.9

Open-heart surgery may be an option to have the mitral valve repaired or replaced. However, as many as half of the symptomatic patients presenting with severe MR, who meet the Class I indications of surgery, do not undergo MV surgery.10 Also, their referral is often delayed until the symptoms are too severe, which leads to sub-optimal long term outcomes. A minimally invasive treatment option that offers an acceptable benefit-risk profile for these patients is needed.

REPAIR MR TRIAL

Join us in the search for treatment alternatives for moderate-risk surgical patients eligible for MitraClip therapy. To find a trial site, click on the button below.

 

LEARN MORE ABOUT THE REPAIR MR TRIAL

MAT-2009573 v1.0 | Item approved for Global OUS use.

References
  1. Lim DS. Contemporary outcomes with MitraClip™ (NTR/XTR) System in primary mitral regurgitation: Results from the Global EXPAND Study. Presented at ACC 2020.
  2. Lim DS, Reynolds MR, Feldman T, et al. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair. J Am Coll Cardiol. 2014;64(2):182-192. doi: 10.1016/j.jacc.2013.10.021.
  3. Dziadzko V. Clavel MA, Dziadzko M, et al. Outcome and undertreatment of mitral regurgitation: a community cohort study. Lancet. 2018:391:960-69.
  4. Cokkinos DV, Belogianneas C. Left ventricular remodeling: a problem in search of solutions. Eur Cardiol Rev. 2016;11(1):29–35.
  5. Seneviratne B, Moore GA, West PD. Effect of captopril on functional mitral regurgitation in dilated heart failure: a randomised double blind placebo controlled trial. Br Heart J. 1994;72(1):63-68.
  6. Bach DS, Awais M, Gurm HS, et al. Failure of guideline adherence for intervention in patients with severe mitral regurgitation. J Am Coll Cardiol. 2009;54(9):860-865.
  7. Badhwar V, Peterson ED, Jacobs JP, et al. Longitudinal outcome of isolated mitral repair in older patients: results from 14,604 procedures performed from 1991 to 2007. Ann Thorac Surg. 2012;94(6):1870-1877.
  8. Toledano K, Rudski LG, Thao Huynh et al. Mitral regurgitation: determinants of referral for cardiac surgery by Canadian cardiologists. Can J Cardiol. 2007;23(3):209-214.
  9. Nasser R, Van Assche L, Vorlat A, et al. Evolution of functional mitral regurgitation and prognosis in medically managed heart failure patients with reduced ejection fraction. JACC Heart Fail. 2017;5:652-659.
  10. Mirabel M, Iung B, Baron G,  et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J. 2007;28(11):1358-1365.

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