Clinical trial NCT02931240: BioVentrix Revivent TC™ System Clinical Study
Official title: Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms (ALIVE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ventricular Dysfunction, Left
Lead sponsor: BioVentrix
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: 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.
timeFrame: 1 Month
measure: 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).
timeFrame: 1 Year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: University of Arizona College of Medicine - Phoenix Banner University Medicine Heart Institute
state: Arizona
city: Los Angeles
country: United States
facility: Ronald Regan UCLA Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Hospital & Medical Center
state: California
city: Miami
country: United States
facility: Baptist Hospital of Maimi
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Marietta
country: United States
facility: WellStar Health System
state: Georgia
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Houma
country: United States
facility: Terrebonne General Medical Center
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Harrisburg
country: United States
facility: UPMC Pinnacle
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: CHI St. Luke's Health-Baylor St. Luke's Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Prague
country: Czechia
facility: Nemocnice Na Homolce
city: Athens
country: Greece
facility: Hygeia Hospital
city: Thessaloniki
country: Greece
facility: Interbalkan Medical Center
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: Drexel University College of Medicine
name: Andrew S Wechsler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Gregg W Stone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Jerry D Estep, MD
role: PRINCIPAL_INVESTIGATOR
References: