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Trial record 2 of 5 for:    carillon

The CARILLON Trial - Assessment of the Carillon® Mitral Contour System® in Treating Functional Mitral Regurgitation Associated With Heart Failure

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ClinicalTrials.gov Identifier: NCT03142152
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Cardiac Dimensions Pty Ltd ( Cardiac Dimensions, Inc. )

Tracking Information
First Submitted Date  ICMJE May 2, 2017
First Posted Date  ICMJE May 5, 2017
Last Update Posted Date March 2, 2020
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • Primary Safety Objective - Freedom from Major Adverse Events [ Time Frame: 12 months ]
    Freedom from a composite of major adverse events (defined as Device Embolization, Vessel Erosion, Cardiac Perforation, and occurrence of cardiac surgery or percutaneous coronary intervention) in the Intervention group is greater than performance goal of 90%.
  • Primary Efficacy Objective 1 - Hierarchical Clinical Composite [ Time Frame: 24 months ]
    To demonstrate that the Carillon Mitral Contour System (Intervention) group is superior to the Control group on the hierarchical composite endpoint of death, transplant or LVAD, percutaneous or surgical mitral valve intervention, heart failure hospitalization, and improvement in six-minute walk distance at 12 months.
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • Primary Safety Objective - Freedom from Major Adverse Events [ Time Frame: 12 months ]
    Freedom from a composite of major adverse events (defined as Device Embolization, Vessel Erosion, Cardiac Perforation, and occurrence of cardiac surgery or percutaneous coronary intervention) in the Intervention group is greater than performance goal of 90%.
  • Primary Efficacy Objective 1 - Hierarchical Clinical Composite [ Time Frame: 12 months ]
    To demonstrate that the Carillon Mitral Contour System (Intervention) group is superior to the Control group on the hierarchical composite endpoint of death, time to first heart failure hospitalization, and improvement in six-minute walk distance. The endpoint will use the Win Ratio analysis method for composite endpoints employing the Finkelstein-Schoenfeld methodology.
  • Primary Efficacy Objective 2 - Change in Regurgitant Volume [ Time Frame: 12 months ]
    To demonstrate a significantly greater decrease from baseline in Regurgitant Volume (assessed by the Echocardiography Core Laboratory) associated with the Carillon Mitral Contour System (Intervention group) relative to the Control group
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Secondary Efficacy Objective 1- Regurgitant Volume [ Time Frame: 12 months ]
    To compare regurgitant volume change relative to control from baseline through 12 months of follow up
  • Secondary Efficacy Objective 2 - HFH Days [ Time Frame: 12 months ]
    To compare heart failure hospitalization days in the Intervention group relative to the Control group, from the time of the index procedure through twelve (12) months.
  • Secondary Efficacy Objective 3 - Change in LV End-Systolic Volume [ Time Frame: 12 months ]
    To demonstrate an improvement from baseline in the parameter left ventricular end-systolic volume (LVESV) associated with the CARILLON Mitral Contour System (Intervention group) relative to the Control group.
  • Secondary Efficacy Objective 4 - Change in 6 Minute Walk Distance [ Time Frame: 12 months ]
    To demonstrate a significantly greater improvement from baseline in six-minute walk distance associated with the CARILLON Mitral Contour System (Intervention group) relative to the Control group.
  • Secondary Efficacy Objective 5 - Change in KCCQ [ Time Frame: 12 months ]
    To demonstrate the improvement from baseline in the overall summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) associated with the CARILLON Mitral Contour System (Intervention group) relative to the Control group.
  • Secondary Efficacy Objective 6 - Change in NYHA Classification [ Time Frame: 12 months ]
    To demonstrate the improvement in the proportion of patients who improve by at least one NYHA class from baseline associated with the CARILLON Mitral Contour System (Intervention group) relative to the Control group.
  • Secondary Safety Objective - Freedom from peri-procedural Major Adverse Events [ Time Frame: 30 days or hospital discharge date, whichever is longer ]
    Freedom from a composite of major adverse events (defined as Death, Myocardial Infarction, Device Embolization, Vessel Erosion, Cardiac Perforation, and occurrence of cardiac surgery or percutaneous coronary intervention) in the Intervention group is greater than 80%.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • Secondary Safety Objective - Freedom from peri-procedural Major Adverse Events [ Time Frame: 30 days or hospital discharge date, whichever is longer ]
    Freedom from a composite of major adverse events (defined as Death, Myocardial Infarction, Device Embolization, Vessel Erosion, Cardiac Perforation, and occurrence of cardiac surgery or percutaneous coronary intervention) in the Intervention group is greater than 80%.
  • Secondary Efficacy Objective 1 - Freedom from Major Adverse Events [ Time Frame: 12 months ]
    To assess the relative risk reduction of heart failure hospitalizations in the Intervention group relative to the Control group, from the time of the index procedure to a minimum of twelve (12) months.
  • Secondary Efficacy Objective 2 - Change in 6 Minute Walk Distance [ Time Frame: 12 months ]
    To demonstrate a significantly greater improvement from baseline in six-minute walk distance associated with the CARILLON Mitral Contour System (Intervention group) relative to the Control group.
  • Secondary Efficacy Objective 3 - Change in LV End-Systolic Volume [ Time Frame: 12 months ]
    To demonstrate an improvement from baseline in the parameter left ventricular end-systolic volume (LVESV) associated with the CARILLON Mitral Contour System (Intervention group) relative to the Control group.
  • Secondary Efficacy Objective 4 - Change in Kansas City Cardiomyopathy Score (Quality of Life measure) [ Time Frame: 12 months ]
    To demonstrate the improvement from baseline in the overall summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) associated with the CARILLON Mitral Contour System (Intervention group) relative to the Control group.
  • Secondary Efficacy Objective 5 - Change in New York Heart Association Classification [ Time Frame: 12 months ]
    To demonstrate the improvement in the proportion of patients who improve by at least one NYHA class from baseline associated with the CARILLON Mitral Contour System (Intervention group) relative to the Control group.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The CARILLON Trial - Assessment of the Carillon® Mitral Contour System® in Treating Functional Mitral Regurgitation Associated With Heart Failure
Official Title  ICMJE Assessment of the Carillon® Mitral Contour System® in Treating Functional Mitral Regurgitation Associated With Heart Failure - The CARILLON Trial
Brief Summary The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating subjects with functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized Control group which is medically managed according to heart failure guidelines.
Detailed Description

A total of 352 subjects will be randomized at up to 75 investigational sites in the United States, Canada, Europe and Australia. Subjects will be randomized into one of two study groups using a 1:1 (Intervention : Control) ratio.

Study subjects who are eligible for this clinical study will undergo a transthoracic echocardiographic examination prior to randomization to evaluate the inclusion criteria associated with the severity of mitral regurgitation as well as a review by a Central Review Committee to determine appropriateness for the implant procedure. On the day of the procedure, a coronary angiogram will be performed to evaluate the coronary artery anatomy and a venogram to assess the suitability of the coronary sinus/great cardiac vein (CS/GCV) for placement of the CARILLON implant. If the subject meets the anatomic requirements for device placement, the subject will be randomized. Subjects who meet all eligibility criteria will be randomized into one of two study groups (Intervention or Control).

Subjects randomized to the Intervention group will undergo the CARILLON implant procedure. With the distal aspect of the device anchored, incremental tension will be applied to plicate the peri-annular tissue. After the proximal anchor of the implant is locked in place, safety and efficacy will be reconfirmed prior to releasing the CARILLON implant from the delivery system.

Subjects randomized to the Control group will experience an index procedure similar to the Intervention group (without device placement) to ensure that they will not be able to deduce the group assignment based on the type of intervention or time associated with the procedure.

After the study subjects are discharged, the subjects' primary care specialists (cardiologist/heart failure physician) and clinical investigation site staff will coordinate follow-up evaluations. Subjects will be evaluated at one (1), six (6), twelve (12), eighteen (18) and twenty-four (24) months post-randomization, to assess long-term safety, and functional and clinical status. After the 24-month evaluation, all subjects will be unblinded. All Intervention and Control subjects will be followed with an abbreviated annual contact for an additional three (3) years, for a total of five (5) years. Any additional therapies which are required to treat symptomatic or advancing disease subjects will be reviewed by a Central Review Committee for endpoint evaluation as long as the subject was treated >6months after randomization so that all subjects may remain on the trial for the entire 5 years of follow up.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Functional Mitral Regurgitation
  • Heart Failure
  • Mitral Valve Insufficiency
  • Heart Diseases
  • Cardiovascular Diseases
  • Heart Valve Diseases
Intervention  ICMJE
  • Device: Carillon Mitral Contour System
    The CARILLON implant (mXE2) is designed to be deployed, tensioned, and locked in the coronary vein in order to reshape the mitral annulus and thus reduce mitral annular dilation and mitral regurgitation.
    Other Names:
    • Carillon mXE2
    • Percutaneous mitral valve repair
  • Other: Guideline Directed Heart Failure Medication
    Heart failure medication per ACC/AHA guidelines
Study Arms  ICMJE
  • Experimental: Intervention Group
    Carillon Mitral Contour System and Guideline Directed Heart Failure Medication
    Interventions:
    • Device: Carillon Mitral Contour System
    • Other: Guideline Directed Heart Failure Medication
  • Active Comparator: Control Group
    Guideline Directed Heart Failure Medication
    Intervention: Other: Guideline Directed Heart Failure Medication
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2019)
352
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2017)
400
Estimated Study Completion Date  ICMJE October 1, 2025
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis of ischemic or non-ischemic cardiomyopathy
  2. Symptomatic functional (secondary) mitral regurgitation defined as both: - 2+ (Moderate), 3+ (Moderate/Severe), or 4+ (Severe).

    Note: 4+ can only be included if multidisciplinary site assessment (including a surgeon) determines that surgery is not necessary within the 1-year follow-up period for this study.

  3. NYHA Class II, III, or IV
  4. Six Minute Walk distance ≥ 150 meters and ≤ 450 meters
  5. Left Ventricular Ejection Fraction ≤ 50%
  6. LVESD ≤ 70 mm Note: As assessed by Imaging Core Laboratory.
  7. Corrected BNP of > 300 pg/ml, or corrected NT-proBNP > 1500 pg/ml, or one or more heart failure hospitalizations within one year prior to consent
  8. Guideline directed heart failure medication regimen.
  9. Age ≥ 18 years old
  10. CARILLON implant can be sized and placed in accordance with the IFU
  11. The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent

Exclusion Criteria:

  1. Recipient of intravenous positive-inotrope infusion or intra-aortic balloon pump support within the past 30 days
  2. Heart failure hospitalization within the past 30 days
  3. Anticipated need of left ventricular assist device within twelve (12) months
  4. Class I indication for cardiac resynchronization therapy (CRT), or anticipated need for CRT within twelve (12) months
  5. Primary renal dysfunction or compromised renal function as reflected by an estimated Glomerular Filtration Rate (eGFR) < 30 ml/min, as assessed by MDRD formula, or patients on dialysis
  6. Heart transplant candidate or prior orthotopic heart transplantation
  7. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device.
  8. Hypertrophic cardiomyopathy, infiltrative cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
  9. Echocardiographic documentation of non-compaction cardiomyopathy as assessed by the Imaging Core Laboratory
  10. Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV)
  11. Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture), as assessed by the Imaging Core Laboratory
  12. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory
  13. Severe mitral annular calcification
  14. Severe aortic stenosis
  15. Not a candidate for right internal jugular venous cannulation
  16. Hospitalization in past 30 days due to myocardial infarction, coronary artery bypass graft surgery or unstable angina
  17. Cerebral vascular event within the past 30 days
  18. Hospitalization in the past 30 days for coronary angioplasty or stent placement or ICD implant
  19. Pulmonary embolus or deep vein thrombosis within the past six (6) months
  20. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
  21. Expected to require any percutaneous coronary intervention within 30 days of the index procedure.
  22. Hemodynamic instability defined as sustained systolic blood pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device
  23. Presence of left atrial appendage (LAA) clot or presence of LAA occluder
  24. Anemia defined as hemoglobin < 9.0 mg/dL
  25. Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
  26. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
  27. Active infections requiring current antibiotic therapy
  28. Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months
  29. Female subjects pregnant or planning to become pregnant in the next five (5) years
  30. Subjects unable to perform the required study assessments (e.g., 6 minute walk test)
  31. Any other medical condition that, in the judgment of the Investigator, makes the patient a poor candidate for this study
  32. Subjects belonging to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or comply with the study procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rebeka McBride, MS 1-425-605-5977 rmcbride@cardiacdimensions.com
Contact: Suzanne Vogt, MS 1-425-605-5931 svogt@cardiacdimensions.com
Listed Location Countries  ICMJE France,   Greece,   Poland,   United Kingdom,   United States
Removed Location Countries Czechia
 
Administrative Information
NCT Number  ICMJE NCT03142152
Other Study ID Numbers  ICMJE CVP 1670-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cardiac Dimensions Pty Ltd ( Cardiac Dimensions, Inc. )
Study Sponsor  ICMJE Cardiac Dimensions, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samir Kapadia, MD The Cleveland Clinic
Principal Investigator: Randall Starling, MD The Cleveland Clinic
Principal Investigator: Marc Gillinov, MD The Cleveland Clinic
PRS Account Cardiac Dimensions Pty Ltd
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP