BioVentrix Revivent TC™ System Clinical Study

Ventricular Dysfunction, Left Clinical Trial

Official title:

Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms (ALIVE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02931240
• Other study ID #: CIP-0066
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 29, 2017
• Est. completion date: June 30, 2027

Study information

• Verified date: August 2023
• Source: BioVentrix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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;

Related Conditions & MeSH terms

• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• Revivent TC
Treatment of LV scar

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
BioVentrix

Countries where clinical trial is conducted

United States,  Czechia,  Greece,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	1 Month
Primary	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).	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.	1 Year
Secondary	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.	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.	1 year

External Links

•   Sponsor Web Site