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Trial record 2 of 494 for:    cardiac dimensions

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 : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Cardiac Dimensions Pty Ltd ( Cardiac Dimensions, Inc. )

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.

Condition or disease Intervention/treatment Phase
Functional Mitral Regurgitation Heart Failure Mitral Valve Insufficiency Heart Diseases Cardiovascular Diseases Heart Valve Diseases Device: Carillon Mitral Contour System Other: Guideline Directed Heart Failure Medication Not Applicable

Detailed Description:

A total of 450 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 2:1 (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. A coronary angiogram will also be performed to evaluate the coronary artery anatomy as a final eligibility (screening) assessment. Subjects who meet all eligibility criteria will be randomized into one of two study groups (Intervention or Control).

Study subjects will undergo 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 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. A transesophageal or transthoracic echocardiogram will be obtained before, during and after device placement to quantitate the degree of functional mitral regurgitation and to evaluate left ventricular function. 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 12-month evaluation, all subjects will be unblinded. Control subjects and Intervention subjects who were not implanted with CARILLON (e.g., due to venous dissection or other procedural complication - "Non-Implanted"), may be offered the option to receive the CARILLON device, as part of a Cross-Over Registry, at the discretion of the study physician and patient.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Carillon® Mitral Contour System® in Treating Functional Mitral Regurgitation Associated With Heart Failure - The CARILLON Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Intervention Group
Carillon Mitral Contour System and Guideline Directed Heart Failure Medication
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

Active Comparator: Control Group
Guideline Directed Heart Failure Medication
Other: Guideline Directed Heart Failure Medication
Heart failure medication per ACC/AHA guidelines




Primary Outcome Measures :
  1. 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%.

  2. 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.

  3. 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 Imaging Core Laboratory) associated with the Carillon Mitral Contour System (Intervention group) relative to the Control group


Secondary Outcome Measures :
  1. 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%.

  2. Secondary Efficacy Objective 1 - Freedom from Major Adverse Events [ 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≥ 200 meters and ≤ 450 meters
  5. Left Ventricular Ejection Fraction ≤ 50%

    1. Subjects with LVEF ≤ 40% have no additional restrictions
    2. Subjects with LVEF > 40% and ≤ 50%

      • MR grade 3+ or 4+ can only be included if the baseline NYHA is class III or IV
      • MR grade 2+ (at rest) can only be included if the baseline NYHA is class III or IV AND left atrial volume > 48mm/m2 (normalized to body surface area)
  6. LVEDD ≤ 70 mm, or LVEDD / BSA ≤ 4.0 cm/m2 Note: As assessed by Imaging Core Laboratory.
  7. Guideline directed heart failure medication regimen. This minimally includes:

    • On ACE inhibitor (ACE-I) for three (3) months with stable dosage for one (1) month (with documentation as to why this is the maximally tolerated medication, or achieving the mean dose as described in the ACCF/ AHA guidelines

      1. This also includes an Angiotensin II Receptor Blocker (ARB) at stable doses for one (1) month prior to subject registration in the trial, if tolerated, when ACE-I is not tolerated.
      2. The use of an angiotensin receptor-neprilysin inhibitor (ARNI) (valsartan/sacubitril) is an acceptable Class I acceptable alternative for use in patients with HFrEF.34
    • On a beta-blocker for three (3) months with stable dosage for one (1) month (with documentation as to why this is the maximally tolerated medication, or achieving the mean dose as described in the ACCF/ AHA guidelines
    • On a diuretic for three (3) months
  8. Age ≥ 18 years old and ≤ 85 years old (assessed at the time of consent)
  9. CARILLON implant can be sized and placed in accordance with the IFU
  10. 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
  6. Status 1 heart transplant 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 for pulmonic, aortic, or tricuspid 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

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): NCT03142152


Contacts
Contact: Rebeka McBride, MS 1-425-605-5977 rmcbride@cardiacdimensions.com
Contact: Suzanne Vogt, MS 1-425-605-5931 svogt@cardiacdimensions.com

Locations
United States, Georgia
Piedmont Heart Institute Not yet recruiting
Atlanta, Georgia, United States, 30309
Contact: Vivek Rajagopal, MD    404-605-6517      
Contact: Kashaine Gray    404.605.2958    kashaine.gray@piedmont.org   
United States, Illinois
NorthShore University Health System Not yet recruiting
Evanston, Illinois, United States, 60201
Contact: Justin Levisay, MD    847-570-2250      
Contact: Laurene Sherman    847.570.3089    lsherman2@northshore.org   
United States, Louisiana
Ochsner Health System Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Stephen Jenkins, MD    504-842-3727      
Contact: Barbara Hirstius    504.842.7222    bhirstius@ochsner.org   
United States, Ohio
Lindner Research Center at the Christ Hospital Not yet recruiting
Cincinnati, Ohio, United States, 45219
Contact: Ian Sarembock, MD    513-585-1777      
Contact: Darlene Rock    513-585-1777    darlene.rock@thechristhospital.com   
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Rita Brienza, BSN    216-444-0122    brienzr@ccf.org   
Principal Investigator: Amar Krishnaswamy, MD         
Czechia
Nemocnice Na Homolce Recruiting
Prague, Czechia
Contact: Katerina Mzourkova       Katerina.Mzourkova@homolka.cz   
France
Pole Sante Republique Not yet recruiting
Clermont Ferrand, France
Contact: Janusz Lipiecki, MD         
Poland
Centrum Medyczne Hcp Recruiting
Poznan, Poland, 61-485
Contact: Piotr Kalmcki, MD    48 605 534009    pkalm@poczta.fm   
United Kingdom
Leeds Teaching Hospital NHS Not yet recruiting
Leeds, United Kingdom
Contact: Klaus Witte, MD         
Sponsors and Collaborators
Cardiac Dimensions, Inc.
Investigators
Principal Investigator: Samir Kapadia, MD The Cleveland Clinic
Principal Investigator: Randall Starling, MD The Cleveland Clinic
Principal Investigator: Marc Gillinov, MD The Cleveland Clinic

Publications:
Responsible Party: Cardiac Dimensions, Inc.
ClinicalTrials.gov Identifier: NCT03142152     History of Changes
Other Study ID Numbers: CVP 1670-01
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Cardiac Dimensions Pty Ltd ( Cardiac Dimensions, Inc. ):
Functional Mitral Regurgitation
Percutaneous Mitral Valve Repair
Percutaneous Mitral Valve Annuloplasty
Coronary Sinus Annuloplasty
Secondary Mitral Regurgitation
Functional MR
FMR

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