BioVentrix Revivent TC™ System Clinical Study

NCT02931240 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CIP-0066
• Study Type: interventional
• Target: 126
• Locations: 4 countries
• Sites: 30

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.

Conditions

Ventricular Dysfunction, Left

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (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.

  1 year

Study Arms (2)

Treatment

EXPERIMENTAL

Treatment with the Revivent TC System

Device: Revivent TC

Control Pool

NO INTERVENTION

Treatment with Guideline Directed Medical Therapy for Heart Failure Symptoms Only

Interventions

Revivent TC DEVICE

Treatment of LV scar

Treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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
• 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

You may not qualify if:

• 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
• Contraindication or inability to adhere to systemic anticoagulation;
• Known hypersensitivity or contraindication to device materials;

Sponsors & Collaborators

• BioVentrix: lead

Study Sites (30)

University of Arizona College of Medicine - Phoenix Banner University Medicine Heart Institute

Phoenix, Arizona, 85004, United States

Location

Ronald Regan UCLA Medical Center

Los Angeles, California, 90024, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360, United States

Location

Baptist Hospital of Maimi

Miami, Florida, 33176, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

WellStar Health System

Marietta, Georgia, 30060, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

Terrebonne General Medical Center

Houma, Louisiana, 70360, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-5856, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Wake Forest Baptist Hospital

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

UPMC Pinnacle

Harrisburg, Pennsylvania, 17101, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

CHI St. Luke's Health-Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

Nemocnice Na Homolce

Prague, 150 30, Czechia

Location

Hygeia Hospital

Athens, 151 23, Greece

Location

Interbalkan Medical Center

Thessaloniki, Greece

Location

Papworth Hospital NHS Foundation Trust

Cambridge, CB23 3RE, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (1)

• Estep JD, Ben-Yehuda O, Wechsler AS, Puri R, Kao AC, Heimes JK, Pfeiffer MP, Boehmer JP, Ninios V, Zaman A, Stone GW. Transcatheter Left Ventricular Reconstruction in Heart Failure Patients With Prior Anterior Myocardial Infarction: The Prospective ALIVE Trial. JACC Heart Fail. 2025 Feb;13(2):296-308. doi: 10.1016/j.jchf.2024.09.023. Epub 2025 Jan 8.

  PMID: 39797846 DERIVED

Related Links

• Sponsor Web Site

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 13, 2016
• Study Start: August 29, 2017
• Primary Completion: December 31, 2023
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2); US (25); GB (2); CZ (1)