Recruiting NCT03142152

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR

No phase Interventional Functional Mitral Regurgitation Heart Failure Mitral Valve Insufficiency Heart Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Carillon Mitral Contour System, Guideline Directed Heart Failure Medication.
Who it may be relevant to: Registry conditions: Functional Mitral Regurgitation, Heart Failure, Mitral Valve Insufficiency, Heart Diseases. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Canada, France, Greece, Italy +3
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).

Detailed description

A total of 300 subjects will be randomized at up to 100 investigational sites in the United States, Canada, and Europe. 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 the Carillon implant 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 implant 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.

Interventions

Device Carillon Mitral Contour System
The Carillon implant 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

Primary outcome measures

Primary Safety Objective - Freedom from Major Adverse Events [Time frame: 12 months]
Primary Efficacy Objective 1 - Hierarchical Clinical Composite [Time frame: 24 months]

Secondary outcome measures (10)

Secondary Efficacy Objective 1- Regurgitant Volume [Time frame: 12 months]
Secondary Efficacy Objective 2 - Change in LV End-diastolic Volume [Time frame: 12 months]
Secondary Efficacy Objective 3 - Change in NYHA [Time frame: 12 months]
Secondary Efficacy Objective 4 - Hierarchical Clinical Composite [Time frame: 12 months]
Secondary Efficacy Objective 5 - Heart Failure Hospitalizations [Time frame: 12 months of follow-up, and any available data up to 24 months]
Exploratory Secondary Endpoint 1 - Change in Six-Minute Walk Distance [Time frame: 12 months]
Exploratory Secondary Endpoint 2 - Change in KCCQ [Time frame: 12 months]
Exploratory Secondary Endpoint 3 - Change in LV End-systolic Volume [Time frame: 12 months]
Exploratory Secondary Endpoint 4 - days lost due to HFH and CV death [Time frame: 12 months of follow-up, and any available data up to 24 months]
Exploratory Secondary Endpoint 5 - Alternative Therapies [Time frame: 12 months of follow-up, and any available data up to 24 months]

Eligibility criteria

Inclusion criteria

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:

≥ 55 mm (women)
≥ 57 mm (men)
LVESD ≤ 75 mm
Corrected NT-proBNP > 1200 pg/ml measured within 60 days of randomization, and/or one or more heart failure hospitalizations within one year prior to consent or one or more outpatient visits for intensification of heart failure therapy within one year prior to consent.
Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee
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

Exclusion criteria

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)
Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
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 judgement of the Investigator or Central Review Committee, makes the patient a poor candidate for this study

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

United States · 75 centers

Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers — Gilbert
Banner Health - Phoenix — Phoenix
AZ Heart Rhythm — Phoenix
Tucson Medical Center Health — Tucson
Banner University Tuscon — Tucson
Memorial Care Hospital — Long Beach
Keck School of Medicine of USC — Los Angeles
UCLA Medical Center — Los Angeles
… and 67 more centers

France · 5 centers

Pole Sante Republique — Clermont-Ferrand
… and 4 more centers

Canada · 4 centers

University of Alberta — Edmonton
St Boniface Hospital - University of Manitoba — Winnipeg
Toronto General Hospital — Toronto
Unity Health Toronto, St Michael's Hospital — Toronto

Spain · 3 centers