ALIVE Expended Access - Clinical Study

NCT05710042 | Unknown

• 1 other identifier: CIP-0067
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Heart Failure; Left Ventricle Remodeling

Keywords

Heart Failure; Left Ventricular Remodeling

Interventions

Revivent TC System DEVICE

The Revivent TC System is indicated for patients suffering from symptomatic heart failure referred for treatment of left ventricular antero-septal aneurysms/scars that are contiguous and includes both anterior and septal components.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Subject or a legally authorized representative must provide written informed consent;
• Agree to required follow-up visits; and
• 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.

You may not qualify if:

• Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 60 days prior to enrollment;
• Valvular heart disease, which in the opinion of the investigator, will require surgery;
• Functional Mitral Regurgitation greater than moderate (i.e. EROA\>20mm sq.) and primary MR (including MR due to papillary muscle rupture);
• Need for coronary revascularization, in the opinion of the site investigator;
• Peak Systolic Pulmonary Arterial Pressure \> 60 mm Hg via echo or right heart catheterization and/or evidence of cor pulmonale;
• Myocardial Infarction within 90 days prior to enrollment;
• Within the last six months, a prior CVA or TIA, or any intracranial hemorrhage, or any permanent neurologic deficit, or any known intracranial pathology;
• Co-morbid disease process with life expectancy of less than one year or active malignancy not in remission;
• Any solid organ transplant or is on waiting list for any solid organ transplant other than cardiac; Page 6 of 64 BioVentrix CIP-0067, Rev A
• Chronic renal failure with a serum creatinine \>2.5 mg/dL and/or GFR\<30ml/min;
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
• Presence of significant ventricular arrhythmias
• Contraindication or inability to adhere to systemic anticoagulation;
• Known hypersensitivity or contraindication to device materials;
• Previous pericardiotomy or left thoracotomy;

Sponsors & Collaborators

• BioVentrix: lead

Study Sites (2)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Heart Failure; Ventricular Remodeling

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregg W Stone, MD

  Icahn School of Medicine at Mount Sinai, New York, NY

  PRINCIPAL INVESTIGATOR

• Jerry Estep, MD

  Cleveland Clinic Florida, Weston, FL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

US (2)