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Active, not recruiting Not applicable

BioVentrix Revivent TC™ System Clinical Study

NCT02931240 · tracked via the Priya Life Science UK tracker
Sponsor
BioVentrix
Phase
Not applicable
Started
2017-08-29
Last updated
2023-08-22

Condition(s) studied

Ventricular Dysfunction, Left

Investigational drug(s) / intervention(s)

Revivent TC

Revivent TC: Treatment of LV scar

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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; * 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 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; * 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;

Primary outcome measure(s)

  • Incidence of all cause death, mechanical support, emergent cardiac surgery, prolonged mechanical ventilation, renal failure and clinically important stroke compared to data from the STS database for surgical LV aneurysm repair. — 1 Month
    Composite primary safety endpoint of all cause death, placement of a mechanical support device intra or post-op (IABP, VAD, ECMO or catheter based), emergent cardiac surgery including reoperation for bleeding or tamponade, prolonged mechanical ventilation, renal failure and clinically important stroke (Rankin Score of 4 or higher) through 30-days post procedure. Data from the patients treated with the Revivent TC System will be compared to surgical outcomes data from the Society for Thoracic Surgery database for surgical LV aneurysm repair.
  • The rate of all cause of death, mechanical support, and operation (or re-operation) for HF, bleeding or tamponade from 1 through 12 months post procedure compared to untreated patients who remain on Guideline Directed Medical Therapy (GDMT). — 1 Year
    A composite of all cause of death, placement of a mechanical support device and operation (or re-operation) for HF, bleeding or tamponade from 1 through 12 months (day 31 through 365) post procedure. Data from patients treated with the Revivent TC System will be compared to data from a control pool of patients who comply with all aspects of the protocol except scar (aneurysm) location and are not treated with the investigational devices remain on Guideline Directed Medical Therapy (GDMT). Patients in the GDMT group will be evaluated from day 31 through 365 after the date of enrollment into the study.

Trial sites (30)

FacilityCityRegionStatus
University of Arizona College of Medicine - Phoenix Banner University Medicine Heart Institute Phoenix Arizona
Ronald Regan UCLA Medical Center Los Angeles California
University of California, San Francisco San Francisco California
Los Robles Hospital & Medical Center Thousand Oaks California
Baptist Hospital of Maimi Miami Florida
Emory University Hospital Midtown Atlanta Georgia
WellStar Health System Marietta Georgia
Memorial Medical Center Springfield Illinois
Terrebonne General Medical Center Houma Louisiana
University of Michigan Ann Arbor Michigan
University of Minnesota Medical Center Minneapolis Minnesota
Saint Luke's Hospital of Kansas City Kansas City Missouri
Hackensack University Medical Center Hackensack New Jersey
Mount Sinai Hospital New York New York
New York Presbyterian Hospital New York New York
Wake Forest Baptist Hospital Winston-Salem North Carolina
Cleveland Clinic Cleveland Ohio
Oklahoma Heart Hospital Oklahoma City Oklahoma
UPMC Pinnacle Harrisburg Pennsylvania
Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania
Hospital of the University of Pennsylvania Philadelphia Pennsylvania
Medical University of South Carolina Charleston South Carolina
CHI St. Luke's Health-Baylor St. Luke's Medical Center Houston Texas
Houston Methodist Hospital Houston Texas
Winchester Medical Center Winchester Virginia
Nemocnice Na Homolce Prague Czechia
Hygeia Hospital Athens Greece
Interbalkan Medical Center Thessaloniki Greece
Papworth Hospital NHS Foundation Trust Cambridge United Kingdom
Freeman Hospital Newcastle upon Tyne United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02931240 on ClinicalTrials.gov ↗ ← All trials in the UK