NO_LONGER_AVAILABLENot Applicable

ALIVE Expended Access - Clinical Study

United States

Plain-language summary

A prospective, multi-center, single-arm study. This study will enroll a maximum of 35 subjects treated with the Revivent TC System.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 18 years old or older;
✓. LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) scar;
✓. LV Aneurysm/Scar Location: Defined as a scar involving septum and/or anterior, apical or anterolateral regions of the left ventricle as evidenced by cardiac imaging and referred for surgical management;

✕. Left Ventricular Ejection Fraction \< 45%;
✕. Left ventricular end-systolic volume index ≥50 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 MLHF Quality of Life Questionnaire (can be performed at baseline visit);
✕. Patient is on adequate Guideline Directed Medical Therapy (GDMT);
✕0. Subject or a legally authorized representative must provide written informed consent;
✕1. Agree to required follow-up visits; and
✕2. 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.

NCT IDNCT05710042

SponsorBioVentrix

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS