Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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) non-calcified scar 3. 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) 4. Left Ventricular Ejection Fraction < 40% 5. Left ventricular end-systolic volume index ≥60 mL/m2 6. Suffering from heart failure symptoms as defined by NYHA Classification > 2 not responsive to medical therapy 7. Patient completed 6 Minute Walk Test and KCCQ Quality of Life Questionnaire (can be performed at baseline visit) 8. Patient is on adequate Guideline Directed Medical Therapy (GDMT) 9. Subject or a legally authorized representative must provide written informed consent 10. Agree to required follow-up visits 11. 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

Exclusion Criteria

Candidates will be excluded from the study if ANY of the following conditions is present: 1. Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 90 days prior to enrollment 2. Valvular heart disease, which in the opinion of the investigator, will require intervention (transcatheter or surgical) 3. Mitral Regurgitation greater than moderate (>2+) 4. Need for coronary revascularization, in the opinion of the investigator 5. Peak Systolic Pulmonary Arterial Pressure > 70 mm Hg via echo or right heart catheterization 6. Myocardial Infarction within 90 days prior to enrollment 7. Within the last six months, a prior CVA or TIA, or intracranial hemorrhage 8. Co-morbid disease process with life expectancy of less than one year or active malignancy not in remission 9. Severe pulmonary disease that would preclude general anesthesia 10. Any solid organ transplant or is on waiting list for any solid organ transplant other than cardiac 11. Chronic renal failure with a GFR<30ml/min 12. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Revivent System Therapy plus Guideline Directed Medical Therapy (GDMT)
Medical Intervention through a mini thoracotomy, placement of anchors to plicate the scarred areas of the heart thereby reducing the left ventricle size and improving left ventricle mechanics. Subjects would continue on Guideline Directed Medical Therapy (GDMT)
  • Device: 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.
No Intervention
Guideline Directed Medical Therapy (GDMT) only
Subjects would remain on Guideline Directed Medical Therapy (GDMT) with no additional medical intervention.

Recruiting Locations

Saint Luke's Hospital of Kansas City
Kansas City 4393217, Missouri 4398678 64131
Contact:
Amanda Huffman, RB, BSN
816-932-0391
ahuffman@saint-lukes.org

Oklahoma Heart Hospital
Oklahoma City 4544349, Oklahoma 4544379 73120
Contact:
Debby Schommer, RN, CCRC
405-608-1286
dschommer@okheart.com

Penn State Health
Hershey 5193342, Pennsylvania 6254927 717033
Contact:
Lisa Fox, BSN, RN
717-531-1468
lfox5@pennstatehealth.psu.edu

More Details

Status
Recruiting
Sponsor
BioVentrix

Study Contact

Steve Chartier
(925) 830-1000
schartier@bioventrix.com

Detailed Description

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.