Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
Starlight Cardiovascular Inc
Study ID
NCT07114718
Status
Recruiting
Apply to this trial

Conditions

  • Congenital Heart Disease
  • Congenital Heart Disease (CHD)

Eligibility Criteria

Sex
ALL
Age
1 Minute - 6 Months
Healthy Volunteers
Not accepted

Interventions

  • Ductus Arteriosus Stent — DEVICE
    The eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.

Study Details

Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System. The study device is a stent that is designed to maintain patency of the Ductus Arteriosus for children who need blood flow through that part of the heart.

Key Dates

Start date
Jan 16, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single Arm - Treatment
    Treatment with the Lifeline Ductus Arteriosus Stent

Primary Outcome Measure

Primary Safety Endpoint [ Time Frame: Implant to 30 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
UCLA Mattel Children'sLos AngelesCalifornia90095
Kirby Johnson
[email protected]
310-267-7600
Sanjay Sinha, MD (PRINCIPAL_INVESTIGATOR)
Leland Stanford Junior UniversityStanfordCalifornia94305
Kifle Yohannes
[email protected]
650-724-4661
Doff McElhinney, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital ColoradoAuroraColorado80045
Madison McPherson
[email protected]
720-777-8403
Jenny Zablah, MD (PRINCIPAL_INVESTIGATOR)
Boston Children's HospitalBostonMassachusetts02115
Lizzy Cooney
[email protected]
617-919-5257
Diego Porras, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Amy Pajk
[email protected]
513-803-0380
Shabana Shahanavaz, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205
Victoria Shay
[email protected]
614-355-5819
Aimee Armstrong, MD (PRINCIPAL_INVESTIGATOR)
Texas Children's Hospital - Baylor College of MedicineHoustonTexas77030
Mauricio Yanez
[email protected]
832-825-5953
Athar Qureshi, MD (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
Jeremy Gillis
[email protected]
206-987-6580
Brian Morray, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
UCLA Mattel Children's· Los Angeles, CALeland Stanford Junior University· Stanford, CAChildren's Hospital Colorado· Aurora, COBoston Children's Hospital· Boston, MACincinnati Children's Hospital Medical Center· Cincinnati, OHNationwide Children's Hospital· Columbus, OH

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