Ventricular Dysfunction, Left
Conditions
Brief 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.
Interventions
DEVICERevivent TC
Treatment of LV scar
Sponsors
BioVentrix
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of re-hospitalization and improvement of HF Symptoms in patients treated with the test device compared to patients who are maintained on Guideline Directed Medical Therapy. | 1 year | Composite primary effectiveness endpoint consisting of: * No hospital readmission for new or worsening heart failure, and * Improvement in MLHF Quality of Life score by \>10 points, and * Improvement in 6 Minute Walk Distance by \>25 meters, and * Improvement in NYHA Classification \> 1 grade. |
Countries
Czechia, Greece, United Kingdom, United States
Outcome results
None listed