BioVentrix Revivent TC™ System Clinical Study

Running, not enrolling · Not applicable

Conditions studied: Ventricular Dysfunction, Left

In brief

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.

Key facts

Study ID: NCT02931240
Run by: BioVentrix
People needed: 126
Starts: 2017-08-29
Expected to finish: 2027-06-30
Last updated by the study team: 2023-08-22

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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;
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 Candidates for the study group must meet ALL of the inclusion criteria.
Candidates allocated to active concurrent control pool of patients must meet all inclusion criteria (including LV Aneurysm/Scar Presence), WITH THE EXCEPTION OF ONE OF THE FOLLOWING:
They have undergone previous pericardiotomy, left thoracotomy, or open heart surgery, or
The LV Aneurysm/Scar location does not permit treatment with the study device, or
The patient elects to be enrolled in the control group

You may not qualify if…

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;
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
The following exclusion criteria apply only to the treatment group and do not apply to the concurrent control cohort:
Contraindication or inability to adhere to systemic anticoagulation;
Known hypersensitivity or contraindication to device materials;
Previous pericardiotomy or left thoracotomy;
Pathology/previous surgery/radiation therapy of the right neck that would interfere with placement of a 14F delivery catheter;
Prior open heart surgery or significant pericarditis;
Calcified ventricular wall in the area of intended anchor implants as verified by cardiac imaging;
Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by cardiac imaging that has not been adequately treated with anticoagulant.
Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement;

Where it is running

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
University of Minnesota Medical Center — Minneapolis, Minnesota, United States
Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Mount Sinai Hospital — New York, New York, United States
New York Presbyterian Hospital — New York, New York, United States
Wake Forest Baptist Hospital — Winston-Salem, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
UPMC Pinnacle — Harrisburg, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Medical University of South Carolina — Charleston, South Carolina, United States
CHI St. Luke's Health-Baylor St. Luke's Medical Center — Houston, Texas, United States
Houston Methodist Hospital — Houston, Texas, United States
Winchester Medical Center — Winchester, Virginia, United States

Full record on ClinicalTrials.gov

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