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Trial record 3 of 7 for:    EVEREST II

Real World Expanded Multicenter Study of the MitraClip® System (REALISM) (REALISM)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01931956
First Posted: August 30, 2013
Last Update Posted: June 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Evalve
  Purpose
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6-month, 12-month, 36-month and 60-month clinical follow-up. The study consists of two arms: a High Risk group (NCT01940120) and a Non-High Risk group (NCT00209274) . Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU).

Condition Intervention
Mitral Valve Insufficiency Mitral Valve Regurgitation Mitral Valve Incompetence Mitral Regurgitation Mitral Insufficiency Device: MitraClip® implant

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Continued Access Registry of the Evalve® MitraClip® System: EVEREST II Real World Expanded Multicenter Study of the MitraClip System (REALISM)

Further study details as provided by Evalve:

Primary Outcome Measures:
  • Major Adverse Events [ Time Frame: 30 days ]
    A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.

  • Major Adverse Events [ Time Frame: 12 months ]
    A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.

  • 12-Month Efficacy [ Time Frame: 12 months ]
    Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR > 2+ (moderate to severe (3+) or severe MR (4+)).


Secondary Outcome Measures:
  • Serious Adverse Events [ Time Frame: 30 days ]
    The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.

  • Serious Adverse Events [ Time Frame: 12 months ]
    The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.

  • Clinically Significant Atrial Septal Defect (ASD) [ Time Frame: 30 days ]
    Defined as the occurrence of clinically significant Atrial Septal Defect (ASD) occurring as a result of the endovascular procedure that requires intervention.

  • Clinically Significant Atrial Septal Defect (ASD) [ Time Frame: 12 months ]
    Defined as the occurrence of clinically significant Atrial Septal Defect (ASD) occurring as a result of the endovascular procedure that requires intervention.

  • Major Adverse Events (MAE) in Patients Over 75 Years of Age [ Time Frame: 30 days ]
    Defined as the occurrence of an MAE in patients over 75 years of age.

  • Major Adverse Events in Patients Over 75 Years of Age [ Time Frame: 12 Months ]
    Defined as the occurrence of an MAE in patients over 75 years of age.

  • Acute Procedural Success [ Time Frame: At discharge (2.4 ± 2.4 days) ]
    Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ or less as determined by the echocardiographic assessment at discharge. The 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or uninterpretable, providing the patient has not undergone subsequent surgery after attempted clip.

  • Procedural Success [ Time Frame: 30 days ]
    Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA at 30 days.

  • Clinical Durability [ Time Frame: 12 months ]
    Defined as the proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that at 12 months have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA at 12 months.

  • New York Heart Association (NYHA) Functional Class [ Time Frame: 30 days ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.


  • NYHA Functional Class [ Time Frame: 12 months ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.


  • Clip Implant Rate [ Time Frame: On the day of index procedure (≤1 day) ]
    Defined as the procedural rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.

  • Post-Procedure Length of Hospital Stay [ Time Frame: 30 days ]
    Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.

  • Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU) Time [ Time Frame: 30 days ]
    Defined as the number of hours patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.

  • Incidence of Discharge to a Nursing Home or Skilled Nursing Facility [ Time Frame: 30 days ]
    Defined as discharge to a nursing home or skilled nursing facility following discharge from the hospital after definitive treatment.

  • Hospital Re-admissions [ Time Frame: 30 days ]
    Defined as re-admission of patients to the hospital following discharge from the Clip procedure.


Other Outcome Measures:
  • 36-Item Short Form Health Survey (SF-36) Quality of Life [ Time Frame: 30 days ]

    The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts:

    • Physical functioning
    • Role limitations due to physical or
    • Emotional health
    • Bodily pain
    • General health perceptions
    • Vitality
    • Social functioning
    • General mental health

    Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.

    The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.


  • 36-Item Short Form Health Survey (SF-36) Quality of Life [ Time Frame: 12 months ]

    The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts:

    • Physical functioning
    • Role limitations due to physical or
    • Emotional health
    • Bodily pain
    • General health perceptions
    • Vitality
    • Social functioning
    • General mental health

    Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.

    The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.


  • Change in 6-Minute Walk Test (6MWT) [ Time Frame: At Baseline and 30 Days ]
    Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.

  • Change in 6-Minute Walk Test (6MWT) [ Time Frame: At Baseline and 12 months ]
    Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.


Enrollment: 66
Study Start Date: November 2008
Estimated Study Completion Date: February 2019
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-High Risk
Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. This arm was evaluated as a separate study NCT00209274.
Device: MitraClip® implant
Percutaneous mitral valve repair using MitraClip implant
Experimental: High Risk
Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. This arm was evaluated as a separate study NCT01940120.
Device: MitraClip® implant
Percutaneous mitral valve repair using MitraClip implant
Experimental: Compassionate Use
Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Device: MitraClip® implant
Percutaneous mitral valve repair using MitraClip implant
Experimental: Emergency Use
Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Device: MitraClip® implant
Percutaneous mitral valve repair using MitraClip implant

Detailed Description:

The EVEREST II REALISM study (REALISM study) is a continued access registry designed for continued data collection on the use of Abbott Vascular's MitraClip System (MitraClip® Device) under more "real world" conditions. After the completion of enrollment in the pivotal EVEREST II Randomized Controlled Trial (RCT) NCT00209274 and EVEREST II High Risk Registry Study NCT01940120, continued access to the technology was warranted to collect additional safety and effectiveness data on the MitraClip® Device. This continued access study was approved by FDA on November 21, 2008 (G030064). There are two arms (High Risk and Non-High Risk) in the REALISM study. Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). Enrollment in the Non-High Risk arm of the study concluded on April 14, 2011 and enrollment in the High Risk arm concluded on December 19, 2013.

REALISM is a prospective, multi-center, study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant). Patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation (MR), as determined by the site from a transthoracic echocardiogram (TTE), were considered for enrollment in this study. The TTE and a transesophageal echocardiogram (TEE) are used to assess eligibility criteria for MR severity, valve anatomy and left ventricular parameters.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patients screened in EVEREST II REALISM Study will first be screened for high risk (HR) status and enrolled into the HR arm if they meet eligibility for this arm of the study. If they do not meet eligibility for the HR arm, patients will be further screened for eligibility for enrollment into the non-high risk (NHR) arm.

Key Inclusion Criteria:

  • The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve (MV)
  • Male or non-pregnant female
  • Trans-septal catheterization is determined to be feasible by the treating physician

High Risk Arm:

  • Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a HR surgical candidate due to the presence of one of the following indications:

    1. Porcelain aorta or mobile ascending aortic atheroma
    2. Post-radiation mediastinum
    3. Previous mediastinitis
    4. Functional MR with EF <40
    5. Over 75 years old with EF<40
    6. Re-operation with patent grafts
    7. Two or more prior chest surgeries
    8. Hepatic cirrhosis
    9. Three or more of the following STS high risk factors 9.1 Creatinine >2.5 mg/dL 9.2 Prior chest surgery 9.3 Age over 75 9.4 EF<35
  • Symptomatic moderate to severe (3+) or severe (4+) chronic MR and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient
  • American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower

Non-High Risk Arm:

  • Moderate to severe (3+) or severe (4+) chronic MV regurgitation and:

    1. Symptomatic with >25% LVEF and LVESD ≤55mm or, 2. Asymptomatic with one or more of the following: i. Left Ventricular Ejection Fraction (LVEF) 25% to 60% ii. Left Ventricular End-Systolic Diameter (LVESD) ≥40 mm iii. New onset of Atrial fibrillation (AFib) iv. Pulmonary arterial systolic pressure (PASP) >50 mmHg at rest or >60 mmHg with exercise

  • Candidate for MV repair or replacement surgery, including cardiopulmonary bypass

Key Exclusion Criteria:

  • Evidence of an Acute Myocardial Infarction (AMI) in the prior 12 weeks of the intended treatment
  • In the judgment of the Investigator, the femoral vein cannot accommodate a 24 French scale (F) catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral Deep Venous Thrombus (DVT) is present
  • MV orifice area <4.0 cm2
  • If leaflet flail is present:

    1. Flail Width ≥15 mm, or
    2. Flail Gap ≥10 mm.
  • If leaflet tethering is present:

    1. Vertical coaptation length <2 mm

  • Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:

    1. Evidence of calcification in the grasping area of the A2 and/or P2 scallops
    2. Presence of a significant cleft of A2 or P2 scallops
    3. More than one anatomic criteria dimensionally near the exclusion limits
    4. Bileaflet flail or severe bileaflet prolapse
    5. Lack of both primary and secondary chordal support
  • Hemodynamic instability (systolic pressure <90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump).
  • Need for emergency surgery for any reason
  • Prior MV surgery or valvuloplasty or any currently implanted mechanical prosthetic valve or currently implanted Ventricular assist device (VAD)
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation
  • Active endocarditis or active rheumatic heart disease or leaflets degenerated from either endocarditis or rheumatic disease (i.e. noncompliant, perforated)
  • History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions
  • Life expectancy <12 months
  • Active infections requiring current antibiotic therapy
  • Patients in whom transesophageal echocardiography (TEE) is contraindicated

High Risk Arm:

  • EF <20%, and/or LVESD >60 mm

Non-High Risk Arm:

  • The need for any other cardiac surgery
  • Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure
  • Severe Left Ventricular (LV) dysfunction (EF <25% and/or LVESD >55mm)
  • Severe mitral annular calcification
  • Systolic anterior motion of the MV leaflet
  • Hypertrophic cardiomyopathy
  • History of a stroke or documented Transient Ischemic Attack (TIA) within the prior 6 months
  • Upper GI bleeding within the prior 6 months
  • Platelet count <75,000 cells/mm³
  • Creatinine >2.5mg/dL
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931956


  Show 38 Study Locations
Sponsors and Collaborators
Evalve
Investigators
Study Director: Ted Feldman, M.D. Feldman, M.D. NorthShore University HealthSystem
Study Director: Donald D Glower Jr., MD Duke University
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Evalve
ClinicalTrials.gov Identifier: NCT01931956     History of Changes
Other Study ID Numbers: 0401B
0401 ( Other Identifier: Abbott Vascular )
First Submitted: August 27, 2013
First Posted: August 30, 2013
Results First Submitted: November 17, 2016
Results First Posted: June 19, 2017
Last Update Posted: June 19, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Evalve:
EVEREST
EVEREST I
EVEREST II
Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Mitral Valve
Mitral Regurgitation (MR)
Mitral Valve Prolapse
Edge to Edge (E2E)
Alfieri Technique
MitraClip
Functional MR
Degenerative MR
Echocardiogram
Coronary Artery Disease (CAD)
Heart Failure
Heart Attack
REALISM

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases