RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial

Обзор

A prospective, multi-center randomized trial comparing the Revivent System plus GDMT to GDMT alone. A total of approximately 135 subjects will be randomized in a 2:1 allocation ratio (90 treatment and 45 control), with approximately 128 evaluable patients and assuming 5% loss to follow-up. A primary safety endpoint will be evaluated at 30 days. Primary efficacy endpoint will be at 1 year. Interim efficacy endpoints will be evaluated at 6 months.

Подробное описание

The purpose of the study is to assess the safety and effectiveness of the BioVentrix Revivent System plus GDMT compared to GDMT alone for the treatment of LV anterior/apical scar/aneurysm with possible additional involvement of the lateral, septal, and/or inferior regions in patients with symptomatic heart failure.

Safety will be assessed compared with a Performance Goal based on surgical ventriculoplasty outcomes (MAE's at 30 days).

Вмешательства

• Устройство Revivent System
  BioVentrix has developed the Revivent System to mirror Surgical Ventricular Restoration (SVR). The Revivent System is used to place permanent cardiac implants to the epicardial surface for the purpose of reconfiguring abnormal cardiac geometry that is contributing to the dysfunction.

Первичные конечные точки

• Major Adverse Events Composite Performance Goal [Срок оценки: 30 days]
• Composite Effectiveness Endpoint [Срок оценки: 6 Months]
• Composite Effectiveness Endpoint [Срок оценки: 12 Months]

Критерии участия

Критерии включения

• 18 years old or older
• LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) non-calcified scar
• LV Aneurysm/Scar Location: Defined as a scar involving anterior, apical or anterolateral ± septal regions of the left ventricle as evidenced by cardiac imaging (Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging)
• Left Ventricular Ejection Fraction < 40%
• Left ventricular end-systolic volume index ≥60 mL/m2
• Suffering from heart failure symptoms as defined by NYHA Classification > 2 not responsive to medical therapy
• Patient completed 6 Minute Walk Test and KCCQ Quality of Life Questionnaire (can be performed at baseline visit)
• Patient is on adequate Guideline Directed Medical Therapy (GDMT)
• Subject or a legally authorized representative must provide written informed consent
• Agree to required follow-up visits
• Female subject of childbearing potential does not plan pregnancy for at least one year following the index procedure. For a female of childbearing potential, a pregnancy test must be performed with negative results known within seven days prior to index procedure

Критерии исключения

Candidates will be excluded from the study if ANY of the following conditions is present:

• Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 90 days prior to enrollment
• Valvular heart disease, which in the opinion of the investigator, will require intervention (transcatheter or surgical)
• Mitral Regurgitation greater than moderate (>2+)
• Need for coronary revascularization, in the opinion of the investigator
• Peak Systolic Pulmonary Arterial Pressure > 70 mm Hg via echo or right heart catheterization
• Myocardial Infarction within 90 days prior to enrollment
• Within the last six months, a prior CVA or TIA, or intracranial hemorrhage
• Co-morbid disease process with life expectancy of less than one year or active malignancy not in remission
• Severe pulmonary disease that would preclude general anesthesia
• Any solid organ transplant or is on waiting list for any solid organ transplant other than cardiac
• Chronic renal failure with a GFR<30ml/min
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint

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

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Banner University Medical Center — Phoenix
• Baptist Health South Florida — Miami
• University of Chicago — Chicago
• Saint Luke's Hospital of Kansas City — Kansas City
• Oklahoma Heart Hospital — Oklahoma City
• Penn State Health — Hershey

Идентификаторы

NCT: NCT06813820 · CIP-0100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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