Идёт набор NCT03142152

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

Без фазы С лечением Functional Mitral Regurgitation Heart Failure Mitral Valve Insufficiency Heart Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Carillon Mitral Contour System, Guideline Directed Heart Failure Medication.
Кому может быть актуально: Состояния в реестре: Functional Mitral Regurgitation, Heart Failure, Mitral Valve Insufficiency, Heart Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Канада, Франция, Греция, Италия +3
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

Устройство 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.
Другое Guideline Directed Heart Failure Medication
Heart failure medication per ACC/AHA guidelines

Первичные конечные точки

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

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Двойное слепое
Основная цель: Лечение

Центры проведения

США · 75 центров

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
… и ещё 67 центров

Франция · 5 центров

Pole Sante Republique — Clermont-Ferrand
… и ещё 4 центра

Канада · 4 центра

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

Испания · 3 центра