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

Status: Recruiting
Location: See all (69) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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 functional regurgitation (FMR).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity

• NYHA II, III, or IV

• Six Minute Walk distance ≥ 100 meters and ≤ 600 meters

• Left Ventricular Ejection Fraction ≤ 50%

• LVEDD ≥ 57 mm and LVESD ≤ 75 mm

• Corrected BNP of \> 300 pg/ml, or corrected NT-proBNP \> 1200 pg/ml, or one or more heart failure hospitalizations within one year prior to consent

• Guideline directed heart failure medication regimen

• Age 18 years old

• Carillon implant can be sized and placed in accordance with the IFU

⁃ The subject 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

Locations
United States
Arizona
Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers
RECRUITING
Gilbert
Banner Health - Phoenix
RECRUITING
Phoenix
Banner University Tuscon
RECRUITING
Tucson
Tucson Medical Center Health
RECRUITING
Tucson
California
Memorial Care Hospital
RECRUITING
Long Beach
Keck School of Medicine of USC
RECRUITING
Los Angeles
UCLA Medical Center
RECRUITING
Los Angeles
Stanford University
RECRUITING
Redwood City
Scripps Health
RECRUITING
San Diego
University of California- San Francisco
RECRUITING
San Francisco
Colorado
South Denver Cardiology
RECRUITING
Littleton
Washington, D.c.
Medstar
RECRUITING
Washington
Florida
University of Miami
RECRUITING
Miami
Advent Health Hospital
RECRUITING
Orlando
Palm Beach Gardens Medical
RECRUITING
Palm Beach
Tallahassee Research Institute
RECRUITING
Tallahassee
Tampa General Hospital
RECRUITING
Tampa
Georgia
Augusta University Research Institute
RECRUITING
Augusta
Wellstar Health System,
RECRUITING
Marietta
Illinois
Advocate Good Samaritan
RECRUITING
Downers Grove
Midwest Cardiovascular Institute (MCI)
RECRUITING
Naperville
Prairie Heart Institute
TERMINATED
Springfield
Indiana
Community Health Network
RECRUITING
Indianapolis
Louisiana
Cardiovascular Institute South
RECRUITING
Houma
Ochsner Health System
RECRUITING
New Orleans
Massachusetts
Beth Israel Deaconess
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
St. Elizabeths
RECRUITING
Boston
Maryland
Johns Hopkins
RECRUITING
Baltimore
Michigan
University of Michigan
WITHDRAWN
Ann Arbor
Ascension St. Marys Research Institute
RECRUITING
Saginaw
Minnesota
CentraCare Heart and Vascular
RECRUITING
Saint Cloud
New Jersey
Deborah Heart & Lung
RECRUITING
Browns Mills
Hackensack University Medical Center
RECRUITING
Edison
New York
Albany Medical College,
WITHDRAWN
Albany
University at Buffalo
RECRUITING
Buffalo
Vassar Brothers- Hudson Valley Cardiovascular Practice
RECRUITING
Poughkeepsie
Ohio
Lindner Research Center at the Christ Hospital
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Harrington Vascular
RECRUITING
Cleveland
The Ohio State University
RECRUITING
Columbus
Kettering Health Research Institute
RECRUITING
Dayton
Oklahoma
Oklahoma Heart Institute Hospital
RECRUITING
Tulsa
Saint Francis Hospital,
RECRUITING
Tulsa
Oregon
Oregon Health & Science University (OHSU)
RECRUITING
Portland
Providence Heart Institute
RECRUITING
Portland
Pennsylvania
Geisinger Medical Center
RECRUITING
Danville
Penn Medicine Lancaster General Health
RECRUITING
Lancaster
Thomas Jefferson University
WITHDRAWN
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
Allegheny Health Network
RECRUITING
Pittsburg
Lankenau Institute of Medical Research
RECRUITING
Wynnewood
South Dakota
North Central Heart-Avera
RECRUITING
Sioux Falls
Tennessee
Centennial Medical Center
RECRUITING
Nashville
Virginia
Henrico Doctors Hospital
RECRUITING
Henrico
Carilion Hospital
RECRUITING
Roanoke
Wisconsin
Advocate Aurora Research Institute
RECRUITING
Milwaukee
Other Locations
Canada
University of Alberta
RECRUITING
Edmonton
Toronto General Hospital
RECRUITING
Toronto
Unity Health Toronto, St Michael's Hospital
RECRUITING
Toronto
St Boniface Hospital - University of Manitoba
RECRUITING
Winnipeg
France
Pole Sante Republique
RECRUITING
Clermont Ferrand
Centre Hospitalier Universitaire De Lille
RECRUITING
Lille
Hôpital Cardiologique Louis Pradel
RECRUITING
Lyon
Clinique du Millènaire Montpelier
RECRUITING
Montpellier
Hôpital Européen Georges-Pompidou
RECRUITING
Paris
Greece
European Interbalkan Medical Center
RECRUITING
Thessaloníki
Poland
Poznan University of Medical Sciences
ACTIVE_NOT_RECRUITING
Poznan
United Kingdom
St James University Hospital
RECRUITING
Leeds
Contact Information
Primary
Hank Hauser
hhauser@cardiacdimensions.com
(310) 228-0016
Time Frame
Start Date: 2018-01-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 300
Treatments
Experimental: Intervention Group
Carillon Mitral Contour System and Guideline Directed Heart Failure Medication
Active_comparator: Control Group
Guideline Directed Heart Failure Medication
Sponsors
Leads: Cardiac Dimensions, Inc.

This content was sourced from clinicaltrials.gov