BiVACOR® Total Artificial Heart Early Feasibility Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
BiVACOR Inc.
Study ID
NCT06174103
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 26, 2024
Status verified
Jul 2024
Primary completion
Aug 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: BiVACOR TAH
    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.

Primary Outcome Measure

Feasibility Endpoint [ Time Frame: 6 months or time of heart transplant (if prior to 6 months post pump implant) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Banner - University Medical Center PhoenixPhoenixArizona85006
Francisco Arabia, MD, MBA
[email protected]
602-377-9310
Duke University HospitalDurhamNorth Carolina27710
Carmelo Milano, MD
[email protected]
919-684-3243
The Christ HospitalCincinnatiOhio45219
Robert D. Dowling, MD
[email protected]
513-585-4880
Texas Heart Institute / Baylor St. Luke's Medical CenterHoustonTexas77030
Joseph G. Rogers, MD
[email protected]
731-790-9401

Find similar trials in Phoenix, AZ

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Banner - University Medical Center Phoenix· Phoenix, AZDuke University Hospital· Durham, NCThe Christ Hospital· Cincinnati, OHTexas Heart Institute / Baylor St. Luke's Medical Center· Houston, TX

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