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BioVentrix Revivent TC™ System Clinical Study

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ClinicalTrials.gov Identifier: NCT02931240
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
BioVentrix

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.

Condition or disease Intervention/treatment Phase
Ventricular Dysfunction, Left Device: Revivent TC Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms (ALIVE)
Actual Study Start Date : August 29, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: Treatment
Treatment with the Revivent TC System
Device: Revivent TC
Treatment of LV scar

No Intervention: Control Pool
Treatment with Guideline Directed Medical Therapy for Heart Failure Symptoms Only



Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.


Secondary Outcome Measures :
  1. 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 ]

    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LV Aneurysm Scar Presence: Defined by a contiguous acontractile (akinetic and/or dyskinetic) scar
  • LV Aneurysm Scar Location: Defined as a scar involving septum and 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
  • 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 group must meet all inclusion criteria (including LV Aneurysm Scar Presence), WITH THE EXCEPTION OF LV Aneurysm Scar Location.

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;
  • Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by cardiac imaging;
  • Cardiac Resynchronization Therapy (CRT) device 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;
  • Prior CVA or TIA within the last six months, or any prior 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;
  • Pulmonary disease that would preclude single lung ventilation;
  • Subject is currently participating in another clinical trial that has not yet completed its primary endpoint;
  • Known hypersensitivity or contraindication to device materials;
  • Previous pericardiotomy or left thoracotomy;
  • Pathology/previous surgery/radiation therapy of the right neck;
  • Prior open heart surgery or significant pericarditis; or
  • Presence of significant ventricular arrhythmias

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931240


Contacts
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Contact: Noel Messenger, MBA (925)830-1000 ext 231 nmessenger@bioventrix.com

Locations
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United States, Louisiana
Cardiovascular Institute of the South Enrolling by invitation
Houma, Louisiana, United States, 70360
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-5856
Contact: Keith Aaronson, MD    888-287-1082    keith@med.umich.edu   
Contact: Neha Shah    734-232-4606    neshah@med.umich.edu   
United States, Minnesota
University of Minnesota Medical Center Enrolling by invitation
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Saint Luke's Hospital of Kansas City Enrolling by invitation
Kansas City, Missouri, United States, 64111
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Peter Canino, RN    551-996-5595    peter.canino@hackensackmeridian.org   
Principal Investigator: Carlos Ruiz, MD         
United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Zachary Taylor    646-501-0197    Zachary.Taylor@nyumc.org   
Principal Investigator: Mathew Williams, MD         
United States, Pennsylvania
University of Pittsburg Medical Center Enrolling by invitation
Pittsburgh, Pennsylvania, United States, 15213
United Kingdom
Papworth Hospital NHS Foundation Trust Enrolling by invitation
Cambridge, United Kingdom, CB23 3RE
Freeman Hospital Recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Contact: Samantha Jones, RN    0191 24 48939    Samantha.Jones@nuth.nhs.uk   
Principal Investigator: Azfar Zaman, MD         
Sponsors and Collaborators
BioVentrix
Investigators
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Principal Investigator: Andrew S Wechsler, MD Drexel University College of Medicine

Additional Information:
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Responsible Party: BioVentrix
ClinicalTrials.gov Identifier: NCT02931240     History of Changes
Other Study ID Numbers: CIP-0066
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases