ALIVE Expended Access - Clinical Study

Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms ALIVE-EA (American Less Invasive Ventricular Enhancement-Expanded Access)

NCT05710042•BioVentrix

View on ClinicalTrials.gov

Summary

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

Detailed Description

The purpose of this study is to allow the continued use of the BioVentrix Revivent TC System for the treatment of LV antero-septal aneurysms/scars in patients with symptomatic heart failure while the pivotal trial for the BioVentrix Revivent TC System is continuing through the follow up phase and the PMA documentation is prepared and reviewed by FDA.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18 years old or older;
•2. LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) scar;
•3. 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;
•4. Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging;
•5. Left Ventricular Ejection Fraction \< 45%;
•6. Left ventricular end-systolic volume index ≥50 mL/m2;
•7. Suffering from heart failure symptoms as defined by NYHA Classification \> 2 not responsive to medical therapy;
•8. Patient completed 6 Minute Walk Test and MLHF Quality of Life Questionnaire (can be performed at baseline visit);
•9. Patient is on adequate Guideline Directed Medical Therapy (GDMT);
•10. Subject or a legally authorized representative must provide written informed consent;
+2 more criteria

Exclusion Criteria

•1. Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 60 days prior to enrollment;
•2. Valvular heart disease, which in the opinion of the investigator, will require surgery;
•3. Functional Mitral Regurgitation greater than moderate (i.e. EROA\>20mm sq.) and primary MR (including MR due to papillary muscle rupture);
•4. Need for coronary revascularization, in the opinion of the site investigator;
•5. Peak Systolic Pulmonary Arterial Pressure \> 60 mm Hg via echo or right heart catheterization and/or evidence of cor pulmonale;
•6. Myocardial Infarction within 90 days prior to enrollment;
•7. Within the last six months, a prior CVA or TIA, or any intracranial hemorrhage, or any permanent neurologic deficit, or any known intracranial pathology;
•8. Co-morbid disease process with life expectancy of less than one year or active malignancy not in remission;
•9. 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
•10. Chronic renal failure with a serum creatinine \>2.5 mg/dL and/or GFR\<30ml/min;
+10 more criteria

Locations (2)

Cleveland Clinic

Cleveland, Ohio, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Key Dates

Last Updated

April 10, 2025

Conditions

Heart FailureLeft Ventricle Remodeling

Interventions

Revivent TC System

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ALIVE Expended Access - Clinical Study

Inclusion Criteria

Exclusion Criteria

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