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BioVentrix Revivent TC™ System Clinical Study | Clinical Trials | Clareo Health

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BioVentrix Revivent TC™ System Clinical Study

Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms (ALIVE)

NCT02931240•BioVentrix

Summary

A prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System, with 2:1 study vs. active concurrent control group allocation ratio. This study will include 126 patients of which 84 patients will be treated with the investigational device and 42 patients will be included in an active control group.

Detailed Description

The Revivent TC System is indicated for patients referred for surgical treatment of left ventricular scar that is contiguous, and includes both anterior and septal components. Primary and Secondary Effectiveness Endpoints will compare data from the patients treated with the Revivent TC System to a control pool of patients who comply with all aspects of the protocol except scar location and are not treated with the investigational devices but remain on Guideline Directed Medical Therapy (GDMT). The primary safety and effectiveness endpoints will be evaluated at 12 months post procedure. The study will be conducted at a maximum of 20 clinical centers.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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;
•Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging;
•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;
+4 more criteria

Exclusion Criteria

•Candidates will be excluded from the study and active concurrent control group if ANY of the following conditions are present:
•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 degenerative 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;
+11 more criteria

Locations (30)

University of Arizona College of Medicine - Phoenix Banner University Medicine Heart Institute

Phoenix, Arizona, United States

Ronald Regan UCLA Medical Center

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Los Robles Hospital & Medical Center

Thousand Oaks, California, United States

Baptist Hospital of Maimi

Miami, Florida, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

WellStar Health System

Marietta, Georgia, United States

Memorial Medical Center

Springfield, Illinois, United States

Terrebonne General Medical Center

Houma, Louisiana, United States

University of Michigan

Ann Arbor, Michigan, United States

Key Dates

Start Date

August 29, 2017

Primary Completion Date

December 31, 2023

Completion Date

June 30, 2027

Last Updated

August 22, 2023

Enrollment

126

ESTIMATED participants

Conditions

Ventricular Dysfunction, Left

Interventions

Revivent TC

DEVICE

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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: August 22, 2023Data 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.

View ClinicalTrials.gov Terms and Conditions

BioVentrix Revivent TC™ System Clinical Study

Inclusion Criteria

Exclusion Criteria

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

Treatment of Heart Failure Using Human Umbilical Cord Mesenchymal Stem Cells(hUC-MSC)

Open-label, Test-retest Study Assessing Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView.

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction