BiVACOR® Total Artificial Heart Early Feasibility Study

NCT06174103 | Recruiting DMC FDA Device

• 1 other identifier: CP-0001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess the feasibility of using the BiVACOR Total Artificial Heart (TAH) System to support adult patients with severe biventricular heart failure, or univentricular heart failure in which left ventricular assist device (LVAD) support is not recommended, who require mechanical circulatory support to sustain life. The BiVACOR TAH System is intended for use as a bridge to transplant (BTT). Feasibility will be assessed by evaluating safety and performance of the BiVACOR TAH System in study subjects.

Conditions

Heart Failure; Biventricular Failure

Outcome Measures

Primary Outcomes (2)

• Feasibility Endpoint

  Survival on the original BiVACOR pump

  6 months or time of heart transplant (if prior to 6 months post pump implant)

• Safety Endpoint

  Evaluation of the safety of the BiVACOR TAH System using INTERMACS adverse event (AE) terms and definitions (INTERMACS Manual of Operations Version 5).

  Through 6 months

Study Arms (1)

BiVACOR TAH

EXPERIMENTAL

The BiVACOR TAH System will be implanted as a bridge to transplant (BTT) for adults with severe irreversible biventricular heart failure or univentricular heart failure in which LVAD support is not recommended, and who are eligible for cardiac transplantation.

Device: BiVACOR TAH System

Interventions

BiVACOR TAH System DEVICE

The BiVACOR pump is an implantable rotary biventricular blood pump that uses magnetic levitation technology for increased durability to replace both ventricles of a failing heart. The device is intended to replace the diseased heart in patients suffering from heart failure to bridge the time to heart transplant.

BiVACOR TAH

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has severe, irreversible biventricular heart failure and is eligible for biventricular mechanical circulatory support based on the International Society of Heart and Lung Transplantation (ISHLT) guidelines or has univentricular heart failure in which LVAD support is not recommended. ISHLT Guidelines for Biventricular Support:
• Biventricular failure with at least two of the following hemodynamic and/or echocardiographic measurements.
• Right ventricular ejection fraction (RVEF) ≤ 30%
• Right ventricular stroke work index (RVSWI) ≤ 0.25 g/m/beat/m2
• Tricuspid annular plane systolic excursion (TAPSE) ≤ 14 mm
• Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio \> 0.72
• Central venous pressure (CVP) \> 15mmHg
• CVP to pulmonary capillary wedge pressure (PCWP) ratio \> 0.63
• Tricuspid insufficiency grade 4
• Pulmonary artery pressure index (PAPi) \< 2
• Treatment-refractory recurrent and sustained ventricular tachycardia or ventricular fibrillation in the presence of untreatable arrhythmogenic pathologic substrate.
• Heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis/senile or other infiltrative heart disease).
• Patient is categorized as INTERMACS Patient Profile Classification 2 or 3.
• Patient is classified as NYHA Class IV.
• Patient has a left ventricular ejection fraction (LVEF) ≤ 25%, with the exception of patients with restrictive or constrictive physiology.

You may not qualify if:

• Patient has contraindications to anticoagulation or antiplatelet therapies.
• Patient has coagulopathy defined by a platelet count \< 50 k/µl.
• Patient has insufficient space in the chest to accommodate the BiVACOR pump.
• Patient has a body mass index (BMI) ≥ 35 kg/m2.
• Patient is highly pre-sensitized prior to pump implantation.
• Patient is unconscious and unresponsive.
• Patient is on pre-implant extracorporeal membrane oxygenation (ECMO) for \> 7 days.
• Patient is on pre-implant temporary MCSD for more than 21 days \[e.g., Intra-aortic balloon pump (IABP), Impella, CentriMag, etc.\] unless ambulatory and free from adverse effects associated with the MCSD.
• Patient is implanted with durable mechanical circulatory support (LVAD or RVAD).
• Patient experienced cerebrovascular accident (CVA) within three months of eligibility evaluation.
• Patient has severe end-organ dysfunction as evidenced by:
• Total bilirubin \> 4.0 mg/dL or cirrhosis confirmed by imaging or positive biopsy, and/or
• Glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2 or renal replacement therapy dependence.
• Patient has severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease requiring home oxygen.
• Patient has primary pulmonary hypertension ≥ 8 Wood units.

Sponsors & Collaborators

• BiVACOR Inc.: lead

Study Sites (4)

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

RECRUITING

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

Texas Heart Institute / Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Dennis Kirven

CONTACT

804-461-1299; dennis.kirven@bivacor.com

Diane Covington

CONTACT

480-794-0232; dcovington@crconcepts-cro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: June 26, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

US (4)