The CARILLON Trial - Assessment of the Carillon® Mitral Contour System® in Treating Functional Mitral Regurgitation Associated With Heart Failure
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03142152|
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : September 21, 2018
|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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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: 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 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 Imaging Core Laboratory) 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%.
- 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.
- 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.
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
|Contact: Rebeka McBride, MSfirstname.lastname@example.org|
|Contact: Suzanne Vogt, MSemail@example.com|
|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 firstname.lastname@example.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 email@example.com|
|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 firstname.lastname@example.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 email@example.com|
|Cleveland, Ohio, United States, 44195|
|Contact: Rita Brienza, BSN 216-444-0122 firstname.lastname@example.org|
|Principal Investigator: Amar Krishnaswamy, MD|
|Nemocnice Na Homolce||Recruiting|
|Contact: Katerina Mzourkova Katerina.Mzourkova@homolka.cz|
|Pole Sante Republique||Not yet recruiting|
|Clermont Ferrand, France|
|Contact: Janusz Lipiecki, MD|
|Centrum Medyczne Hcp||Recruiting|
|Poznan, Poland, 61-485|
|Contact: Piotr Kalmcki, MD 48 605 534009 email@example.com|
|Leeds Teaching Hospital NHS||Not yet recruiting|
|Leeds, United Kingdom|
|Contact: Klaus Witte, MD|
|Principal Investigator:||Samir Kapadia, MD||The Cleveland Clinic|
|Principal Investigator:||Randall Starling, MD||The Cleveland Clinic|
|Principal Investigator:||Marc Gillinov, MD||The Cleveland Clinic|