- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02931240
BioVentrix Revivent TC™ System Clinical Study
Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms (ALIVE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Noel Messenger, MBA
- Phone Number: 231 (925)830-1000
- Email: nmessenger@bioventrix.com
Study Locations
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Prague, Czechia, 150 30
- Nemocnice Na Homolce
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Athens, Greece, 151 23
- Hygeia Hospital
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Thessaloniki, Greece
- Interbalkan Medical Center
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Cambridge, United Kingdom, CB23 3RE
- Papworth Hospital NHS Foundation Trust
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Newcastle Upon Tyne, United Kingdom, NE7 7DN
- Freeman Hospital
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Arizona
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Phoenix, Arizona, United States, 85004
- University of Arizona College of Medicine - Phoenix Banner University Medicine Heart Institute
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California
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Los Angeles, California, United States, 90024
- Ronald Regan UCLA Medical Center
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Thousand Oaks, California, United States, 91360
- Los Robles Hospital & Medical Center
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Florida
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Miami, Florida, United States, 33176
- Baptist Hospital of Maimi
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Georgia
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Atlanta, Georgia, United States, 30308
- Emory University Hospital Midtown
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Marietta, Georgia, United States, 30060
- WellStar Health System
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Illinois
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Springfield, Illinois, United States, 62781
- Memorial Medical Center
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Louisiana
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Houma, Louisiana, United States, 70360
- Terrebonne General Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48109-5856
- University of Michigan
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical Center
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Missouri
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Kansas City, Missouri, United States, 64111
- Saint Luke's Hospital of Kansas City
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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New York
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New York, New York, United States, 10029
- Mount Sinai Hospital
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New York, New York, United States, 10065
- New York Presbyterian Hospital
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Hospital
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
- Oklahoma Heart Hospital
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Pennsylvania
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Harrisburg, Pennsylvania, United States, 17101
- UPMC Pinnacle
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Hershey, Pennsylvania, United States, 17033
- Penn State Health Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Texas
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Houston, Texas, United States, 77030
- Houston Methodist Hospital
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Houston, Texas, United States, 77030
- CHI St. Luke's Health-Baylor St. Luke's Medical Center
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Virginia
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Winchester, Virginia, United States, 22601
- Winchester Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Treatment
Treatment with the Revivent TC System
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Treatment of LV scar
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No Intervention: Control Pool
Treatment with Guideline Directed Medical Therapy for Heart Failure Symptoms Only
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 1 Month
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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.
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1 Month
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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).
Time Frame: 1 Year
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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.
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1 Year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 1 year
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Composite primary effectiveness endpoint consisting of:
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew S Wechsler, MD, Drexel University College of Medicine
- Principal Investigator: Gregg W Stone, MD, Icahn School of Medicine at Mount Sinai
- Principal Investigator: Jerry D Estep, MD, The Cleveland Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIP-0066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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