A Study Of Surgical Repair Of Discontinuous Branching Pulmonary Arteries

Conditions

• Absent Pulmonary Artery

Eligibility Criteria

Sex

ALL

Age

6 Months - 2 Years

Healthy Volunteers

Not accepted

Interventions

• Acellular Tissue Engineered Vessel (ATEV) Conduit — BIOLOGICAL
  A sterile, single-use acellular vascular graft/conduit surgically implanted once to restore pulmonary blood flow from the main pulmonary artery to the lung in infants with discontinuous pulmonary arteries. Participants receive standard perioperative care and post-implant antithrombotic therapy per protocol.

Study Details

The purpose of this study is to test the safety and performance of a new blood vessel graft, called the ATEV. The graft is designed to reconnect the heart to the lungs and to grow as the child grows, which may eliminate the need for future surgeries.

Key Dates

First listed

Aug 25, 2026

Start date

Oct 1, 2026

Status verified

Aug 2026

Primary completion

Aug 31, 2030

Completion

Aug 31, 2030

Study Design

Enrollment

6 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ATEV Conduit Implantation
  Infants with discontinuous pulmonary arteries requiring conduit placement will undergo surgical implantation of one acellular tissue engineered vessel (ATEV) conduit to restore pulmonary blood flow from the main pulmonary artery to the lung. Participants will receive standard-of-care perioperative management and post-implant antithrombotic therapy and will be followed for 24 months after implantation.

Primary Outcome Measure

Treatment emergent adverse events [ Time Frame: 12 months post-implantation ]

Central Contacts

• CV Surgery Research Team
  507-266-9515
  [email protected]

Locations (1)

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