Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Vaikom Mahadevan, MD
Headshot of Vaikom Mahadevan
Vaikom Mahadevan

Description

Summary

The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating heart failure with at least mild functional regurgitation.

Official Title

Assessment of the Carillon® Mitral Contour System® in Treating Heart Failure With at Least Mild Functional Mitral Regurgitation

Details

A total of 300 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 and echocardiogram 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.

Keywords

Functional Mitral Regurgitation, Heart Failure, Mitral Valve Insufficiency, Heart Diseases, Cardiovascular Diseases, Heart Valve Diseases, Percutaneous Mitral Valve Repair, Percutaneous Mitral Valve Annuloplasty, Coronary Sinus Annuloplasty, Secondary Mitral Regurgitation, Functional MR, FMR, Carillon Mitral Contour System, Guideline Directed Heart Failure Medication

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Diagnosis of ischemic or non-ischemic cardiomyopathy
  2. Symptomatic functional (secondary) mitral regurgitation of at least 1+ (Mild) severity

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.

  1. NYHA Class II, III, or IVa
  2. Six Minute Walk distance ≥ 150 meters and ≤ 450 meters
  3. Left Ventricular Ejection Fraction ≤ 50%
  4. LVEDD ≥ 60 mm and LVESD ≤ 70 mm Note: As assessed by Imaging Core Laboratory.
  5. Corrected BNP of ≥ 300 pg/ml, or corrected NT-proBNP ≥ 1200 pg/ml, or one or more heart failure hospitalizations within six months prior to consent
  6. Guideline directed heart failure medication regimen.
  7. Age ≥ 18 years old
  8. . CARILLON implant can be sized and placed in accordance with the IFU
  9. . 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

You CAN'T join if...

  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. Unlikely to benefit from annular reduction therapy
  8. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
  9. Hypertrophic cardiomyopathy, infiltrative cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
  10. . Echocardiographic documentation of non-compaction cardiomyopathy as assessed by the Imaging Core Laboratory
  11. . Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV)
  12. . 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
  13. . Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory
  14. . Severe mitral annular calcification
  15. . Severe aortic stenosis
  16. . Not a candidate for right internal jugular venous cannulation
  17. . Hospitalization in past 30 days due to myocardial infarction, coronary artery bypass graft surgery or unstable angina
  18. . Cerebral vascular event within the past 30 days
  19. . Hospitalization in the past 30 days for coronary angioplasty or stent placement or ICD implant
  20. . Pulmonary embolus or deep vein thrombosis within the past six (6) months
  21. . Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
  22. . Expected to require any percutaneous coronary intervention within 30 days of the index procedure.
  23. . 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
  24. . Presence of left atrial appendage (LAA) clot or presence of LAA occluder
  25. . Anemia defined as hemoglobin < 9.0 mg/dL
  26. . 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
  27. . Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
  28. . Active infections requiring current antibiotic therapy
  29. . Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months
  30. . Female subjects pregnant or planning to become pregnant in the next five (5) years
  31. . Subjects unable to perform the required study assessments (e.g., 6 minute walk test)
  32. . Any other medical condition that, in the judgment of the Investigator, makes the patient a poor candidate for this study
  33. . 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

Locations

  • University of California- San Francisco accepting new patients
    San Francisco California 94143 United States
  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCSF

  • Vaikom Mahadevan, MD
    Dr. Vaikom S Mahadevan joined UCSF from the UK in July 2014 as Director of Structural and Adult Congenital cardiac Interventions and the Wiliam W Parmley Endowed Chair in Cardiology and Associate Professor of Medicine. Following completion of his intital medical training in Stanley Medical College in India Dr. Mahadevan did his higher Internal Medicine and Cardiology training …

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cardiac Dimensions, Inc.
ID
NCT03142152
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated