BioVentrix Revivent TC System Clinical Study

STATUS

Recruiting
End date

Dec 31, 2025
participants needed

126
sponsor

BioVentrix

Send

Updated on 20 March 2021

See if I qualify

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 Identifier	NCT02931240
Sponsor	BioVentrix
Last Modified on	20 March 2021

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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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BioVentrix Revivent TC System Clinical Study