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-2009572 v1.0 | Item approved for U.S. use only.

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.
Important safety information

MITRACLIP DELIVERY SYSTEMS
INDICATION FOR USE

  • The MitraClip™ G4 System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
  • The MitraClip™ G4 System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III  per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

CONTRAINDICATIONS

The MitraClip™ G4 System is contraindicated in patients with the following conditions:

  • Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regimen
  • Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity
  • Active endocarditis of the mitral valve
  • Rheumatic mitral valve disease
  • Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

WARNINGS

  • DO NOT use MitraClip outside of the labeled indication.
  • The MitraClip™ G4 Implant should be implanted with sterile techniques using fluoroscopy and echocardiography (e.g. transesophageal [TEE] and transthoracic [TTE]) in a facility with on-site cardiac surgery and immediate access to a cardiac operating room.
  • Read all instructions carefully. Use universal precautions for biohazards and sharps while handling the MitraClip™ G4 System to avoid user injury. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury including:
    • MitraClip™ G4 Implant erosion, migration or malposition
    • Failure to deliver MitraClip™ G4 Implant to the  intended site
    • Difficulty or failure to retrieve MitraClip™ G4 system components
  • Use caution when treating patients with hemodynamic instability requiring inotropic support or mechanical heart assistance due to the increased risk of mortality in this patient population. The safety and effectiveness of MitraClip™ in these patients has not been evaluated.
  • Patients with a rotated heart due to prior cardiac surgery in whom the System is used may have a potential risk of experiencing adverse events such as atrial perforation, cardiac tamponade, tissue damage, and embolism which may be avoided with preoperative evaluation and proper device usage.
  • For the Steerable Guide Catheter and Delivery Catheter only:
    • The Guide Catheter: the distal 65 cm of the Steerable Guide Catheter with the exception of the distal soft tip, is coated with a hydrophilic coating.
    • The Delivery Catheter: coated with a hydrophilic coating for a length of approximately 131 cm.
    • Failure to prepare the device as stated in these instructions and failure to handle the device with  care could lead to additional intervention or serious adverse event.
  • The Clip Delivery System is provided sterile and designed for single use only. Cleaning, re-sterilization and / or re-use may result in infections, malfunction of the device and other serious injury or death.
  • Note the product “Use by“ date specified on the package.
  • Inspect all product prior to use. Do not use if the package is open or damaged, or if product is damaged.

PRECAUTIONS

  • Prohibitive Risk Primary (or degenerative) Mitral Regurgitation
    • Prohibitive risk is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, due to the presence of one or more of the following documented surgical risk factors:
      • 30-day STS predicted operative mortality risk score of
        • ≥8% for patients deemed likely to undergo mitral valve replacement or
        • ≥6% for patients deemed likely to undergo mitral valve repair
    • Porcelain aorta or extensively calcifed ascending aorta.
    • Frailty (assessed by in-person cardiac surgeon consultation)
    • Hostile chest
    • Severe liver disease / cirrhosis (MELD Score > 12)
    • Severe pulmonary hypertension (systolic pulmonary artery pressure > 2/3 systemic pressure)
    • Unusual extenuating circumstance, such as right ventricular dysfunction with severe tricuspid regurgitation, chemotherapy for malignancy, major bleeding diathesis, immobility, AIDS, severe dementia, high risk of aspiration, internal mammary artery (IMA) at high risk of injury, etc.
    • Evaluable data regarding safety or effectiveness is not available for prohibitive risk Primary patients with an LVEF < 20% or an LVESD > 60 mm. MitraClip™ should be used only when criteria for clip suitability for Primary have been met.
    • The heart team should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease and may also include appropriate physicians to assess the adequacy of heart failure treatment and valvular anatomy.
  • Secondary Mitral Regurgitation
    • Evaluable data regarding safety or effectiveness is not available for secondary MR patients with an LVEF < 20% or an LVESD > 70 mm.
    • The multidisciplinary heart team should be experienced in the evaluation and treatment of heart failure and mitral valve disease and determine that symptoms and MR severity persist despite maximally tolerated GDMT.

POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip™ G4 procedure.

  • Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs
  • Vascular access complications which may require transfusion or vessel repair including:
    • wound dehiscence
    • catheter site reactions
    • Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage)
    • Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion
    • Emboli (air thrombotic material, implant, device component)
    • Peripheral Nerve Injury
  • Lymphatic complications
  • Pericardial complications which may require additional intervention, including:
    • Pericardial effusion
    • Cardiac tamponade
    • Pericarditis
  • Cardiac complications which may require additional interventions or emergency cardiac surgery, including:
    • Cardiac perforation
    • Atrial septal defect
  • Mitral valve complications, which may complicate or prevent later surgical repair, including:
    • Chordal entanglement / rupture
    • Single Leaflet Device Attachment (SLDA)
    • Thrombosis
    • Dislodgement of previously implanted devices
    • Tissue damage
    • Mitral valve stenosis
    • Persistent or residual mitral regurgitation
    • Endocarditis
  • Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias)
  • Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina)
  • Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism)
  • Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA)
  • System organ failure:
    • Cardio-respiratory arrest
    • Worsening heart failure
    • Pulmonary congestion
    • Respiratory dysfunction / failure / atelectasis
    • Renal insufficiency or failure
    • Shock (including cardiogenic and anaphylactic)
  • Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT))
  • Hypotension / hypertension
  • Infection including:
    • Urinary Tract Infection (UTI)
    • Pneumonia
    • Septicemia
  • Nausea / vomiting
  • Chest pain
  • Dyspnea
  • Edema
  • Fever or hyperthermia
  • Pain
  • Death
  • Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications:
    • Skin injury or tissue changes due to exposure to  ionizing radiation
    • Esophageal irritation
    • Esophageal perforation
    • Gastrointestinal bleeding

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