BioVentrix Revivent TC System Clinical Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    126
  • sponsor
    BioVentrix
Updated on 20 March 2021
medical therapy
ejection fraction
heart failure
6-minute walk test

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.

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.

Details
Condition LEFT VENTRICULAR DYSFUNCTION
Treatment Revivent TC
Clinical Study IdentifierNCT02931240
SponsorBioVentrix
Last Modified on20 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years old or older
LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) scar
Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging
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
Left ventricular end-systolic volume index 50 mL/m2
Left Ventricular Ejection Fraction < 45%
Suffering from heart failure symptoms as defined by NYHA Classification > 2 not responsive to medical therapy
Patient is on adequate Guideline Directed Medical Therapy (GDMT)
Patient completed 6 Minute Walk Test and MLHF Quality of Life Questionnaire (can be performed at baseline visit)
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
Calcified ventricular wall in the area of intended anchor implants as verified by cardiac imaging
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
Contraindication or inability to adhere to systemic anticoagulation
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
Known hypersensitivity or contraindication to device materials
The following exclusion criteria apply only to the treatment group and do not
Previous pericardiotomy or left thoracotomy
apply to the concurrent control cohort
Presence of significant ventricular arrhythmias
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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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