Heart Failure Clinical Trial

The EMPOWER Trial – The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

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).

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Full Description

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. 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.

Subjects randomized to the Control group will experience an index procedure similar to the Intervention group (without device placement) to ensure 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of ischemic or non-ischemic cardiomyopathy
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.
NYHA Class 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 six months prior to consent
Guideline directed heart failure medication regimen.

Exclusion Criteria:

Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV) or Class I indication for cardiac resynchronization therapy (CRT)
Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
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
Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory
Severe mitral annular calcification
Severe aortic stenosis
Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year

Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months or any other medical condition that, in the judgment of the Investigator, makes the patient a poor candidate for this study

An entire list of eligibility is available in the clinical investigational plan

Study is for people with:

Heart Failure

Estimated Enrollment:

300

Study ID:

NCT03142152

Recruitment Status:

Recruiting

Sponsor:

Cardiac Dimensions, Inc.

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There are 59 Locations for this study

See Locations Near You

Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers
Gilbert Arizona, 85297, United States More Info
Natalie Leon
Contact
[email protected]
Nabil Dib, MD
Principal Investigator
Banner Health - Phoenix
Phoenix Arizona, 85006, United States More Info
Arianna Bedoya
Contact
[email protected]
Tucson Medical Center Health
Tucson Arizona, 85712, United States More Info
Mary Marsh
Contact
[email protected]
Banner University Tuscon
Tucson Arizona, 85724, United States More Info
Karina Carrillo
Contact
[email protected]
Arka Chatterjee, MD
Principal Investigator
Keck School of Medicine of USC
Los Angeles California, 90033, United States More Info
Blanca Garcia
Contact
[email protected]
UCLA Medical Center
Los Angeles California, 90095, United States More Info
Ladda Douangvila
Contact
[email protected]
Olcay Aksoy, MD
Principal Investigator
Scripps Health
San Diego California, 92037, United States More Info
Alison Walton
Contact
[email protected]
University of California- San Francisco
San Francisco California, 94143, United States More Info
Kaye Reambonanza
Contact
[email protected]
Richard Cheng, MD
Principal Investigator
Harbor-UCLA Medical Center
Torrance California, 90502, United States
Medstar
Washington District of Columbia, 20010, United States More Info
Megan Fuller
Contact
[email protected]
Miguel Pinilla-Vera, MD
Principal Investigator
Baptist Hospital of Miami
Miami Florida, 33101, United States More Info
Ramon Quesada, MD
Principal Investigator
Naples Heart Institute
Naples Florida, 34102, United States More Info
Kathy Byrd
Contact
[email protected]
Advent Health Hospital
Orlando Florida, 32803, United States More Info
James Duryea
Contact
[email protected]
Tallahassee Research Institute, Inc
Tallahassee Florida, 32308, United States More Info
Katherine Gearld
Contact
[email protected]
Augusta University Research Institute
Augusta Georgia, 30912, United States More Info
Michelle Rodriguez-Santiago
Contact
[email protected]
Evan Hiner, MD
Principal Investigator
Carle Foundation Hospital
Champaign Illinois, 61801, United States
Rush University
Chicago Illinois, 60612, United States
Advocate Good Samaritan
Downers Grove Illinois, 60515, United States More Info
Lynn McLennan
Contact
[email protected]
NorthShore University Health System
Evanston Illinois, 60201, United States
Midwest Cardiovascular Institute (MCI)
Naperville Illinois, 60540, United States More Info
Josilyn Klimek
Contact
[email protected]
Prairie Heart Institute
Springfield Illinois, 62701, United States
Community Health Network
Indianapolis Indiana, 46250, United States More Info
Brenda Newman
Contact
Community Health Network
Indianapolis Indiana, 46256, United States More Info
Brenda Newman
Contact
[email protected]
Community Healthcare System
Munster Indiana, 46321, United States
Cardiovascular Research Institute of Kansas
Wichita Kansas, 67226, United States More Info
Meredith Thunberg
Contact
[email protected]
Cardiovascular Institute South
Houma Louisiana, 70360, United States More Info
Vaidehi Patel
Contact
[email protected]
Peter Fail, MN
Principal Investigator
Ochsner Health System
New Orleans Louisiana, 70121, United States More Info
Angel Penning
Contact
[email protected]
Stephen Jenkins, MD
Principal Investigator
St. Elizabeths
Boston Massachusetts, 02135, United States More Info
Rina Vaquerano
Contact
[email protected]
Richard Patten, MD
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02145, United States More Info
Rahul Sakhuja, MD
Principal Investigator
Baystate Medical Center
Springfield Massachusetts, 01199, United States
University of Michigan
Ann Arbor Michigan, 48859, United States More Info
Allison Schley
Contact
[email protected]
Daniel Menees, MD
Principal Investigator
William Beaumont Health
Royal Oak Michigan, 48073, United States
Ascension St. Marys Research Institute
Saginaw Michigan, 48601, United States More Info
Kristin Levasseur
Contact
[email protected]
Safwan Kassas, MD
Principal Investigator
CentraCare Heart and Vascular
Saint Cloud Minnesota, 57584, United States More Info
Jordan Spaulding
Contact
[email protected]
Deborah Heart & Lung
Browns Mills New Jersey, 08015, United States More Info
Andrew McElvarr, BS
Contact
[email protected]
Richard Kovach
Principal Investigator
University at Buffalo
Buffalo New York, 14203, United States More Info
Kennedy Whitley
Contact
[email protected]
Columbia University Medical Center
New York New York, 10027, United States
Vassar Brothers- Hudson Valley Cardiovascular Practice
Poughkeepsie New York, 12601, United States More Info
Tricia Landi
Contact
[email protected]
Rajeev Narayan, MD
Principal Investigator
Lindner Research Center at the Christ Hospital
Cincinnati Ohio, 45219, United States More Info
Dean Kereiakes, MD
Principal Investigator
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Emily Tylicki
Contact
[email protected]
Amar Krishnaswamy, MD
Principal Investigator
The Ohio State University
Columbus Ohio, 43210, United States More Info
Alexa Golloh
Contact
[email protected]
Mount Carmel
Columbus Ohio, 43219, United States More Info
Elissa VanKirk
Contact
[email protected]
Kettering Health Research Institute
Dayton Ohio, 45459, United States More Info
Chris Seger
Contact
[email protected]
Oklahoma Heart Hospital
Oklahoma City Oklahoma, 73120, United States More Info
Stacie Hanes
Contact
[email protected]
Mohammad Ghani, MD
Principal Investigator
Oregon Health & Science University (OHSU)
Portland Oregon, 97225, United States More Info
John Halvorson
Contact
[email protected]
Providence Heart Institute
Portland Oregon, 97225, United States More Info
Sarah Jackson
Contact
[email protected]
Geisinger Medical Center
Danville Pennsylvania, 17822, United States More Info
Shikhar Agarwal, MD
Principal Investigator
Penn Medicine Lancaster General Health
Lancaster Pennsylvania, 17602, United States More Info
Andy Hershey
Contact
[email protected]
University of Pennsylvania
Philadelphia Pennsylvania, 19014, United States More Info
Karen Maslowski
Contact
[email protected]
Gene Chang, MD
Principal Investigator
Allegheny Health Network
Pittsburgh Pennsylvania, 15212, United States More Info
Tracy Spirk
Contact
[email protected]
UPMC Presbyterian
Pittsburgh Pennsylvania, 15213, United States More Info
Rachel McGargle
Contact
[email protected]
AJ Conrad Smith, MD
Principal Investigator
Methodist Le Bonheur Healthcare
Germantown Tennessee, 38138, United States More Info
Carol Jones
Contact
[email protected]
Mehul Patel, MD
Principal Investigator
Centennial Medical Center
Nashville Tennessee, 37203, United States More Info
Abigail Bentley
Contact
[email protected]
Andrew Goodman, MD
Principal Investigator
UT Health Houston
Houston Texas, 77030, United States More Info
Jose Morales Madrid
Contact
[email protected]
Intermountain Medical Center
Murray Utah, 84111, United States More Info
MJ Chevesich
Contact
[email protected]
Henrico Doctors Hospital
Henrico Virginia, 23229, United States More Info
Amma Agyemang
Contact
[email protected]
Robert Levitt, MD
Principal Investigator
Sentara Norfolk General
Norfolk Virginia, 23501, United States
Carilion Hospital
Roanoke Virginia, 24014, United States More Info
Brittny O'Toole
Contact
[email protected]
Advocate Aurora Research Institute
Milwaukee Wisconsin, 53215, United States More Info
Dena Burke
Contact
[email protected]
Pole Sante Republique
Clermont Ferrand , , France More Info
Nicolas Caillor-Bascoul
Contact
[email protected]
Janusz Lipiecki, MD
Principal Investigator
European Interbalkan Medical Center
Thessaloníki , , Greece More Info
Sosanna Konstantinidou
Contact
[email protected]
Vlasios Ninios, MD
Principal Investigator
Poznan University of Medical Sciences
Poznan , 61-48, Poland More Info
Tomasz Siminiak, MD
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

300

Study ID:

NCT03142152

Recruitment Status:

Recruiting

Sponsor:


Cardiac Dimensions, Inc.

How clear is this clinincal trial information?

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