NCT05547165: PIVOTAL

Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants

Recruiting now NA Last updated 30 March 2025

What this trial tests

NA trial testing Percutaneous Patent Ductus Arteriosus Closure (PPC) in Ductus Arteriosus, Patent in 240 participants. Currently enrolling.

Timeline

21 February 2023

Primary endpoint
28 February 2026

28 February 2026

Quick facts

Lead sponsor	Nationwide Children's Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	240
Start date	21 February 2023
Primary completion	28 February 2026
Estimated completion	28 February 2026
Sites	24 locations across United States

Drugs / interventions tested

• Percutaneous Patent Ductus Arteriosus Closure (PPC)
• Responsive Management Intervention
• Echocardiogram, cardiac

Conditions studied

• Ductus Arteriosus, Patent — all drugs for Ductus Arteriosus, Patent →

Sponsor

Nationwide Children's Hospital

Who can join

Adults 7 Days to 32 Days, any sex, with Ductus Arteriosus, Patent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment.

There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The molecular mechanisms of cardiac development and related diseases.
   Li Y, Du J, Deng S, Liu B, et al · · 2024 · cited 53× · PMID 39715759 · DOI 10.1038/s41392-024-02069-8
2. Secular Trends in Patent Ductus Arteriosus Management in Infants Born Preterm in the National Institute of Child Health and Human Development Neonatal Research Network.
   Kaluarachchi DC, Rysavy MA, Carper BA, Chock VY, et al · · 2024 · cited 26× · PMID 38135028 · DOI 10.1016/j.jpeds.2023.113877
3. 3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo™ Occluder for transcatheter patent ductus arteriosus closure in children ≥ 700 grams.
   Morray BH, Sathanandam SK, Forbes T, Gillespie M, et al · · 2023 · cited 25× · PMID 37587183 · DOI 10.1038/s41372-023-01741-1
4. Changes in Patent Ductus Arteriosus Management and Outcomes in Infants Born at 26-28 Weeks' Gestation.
   Kaluarachchi DC, Rysavy MA, Do BT, Chock VY, et al · · 2025 · cited 5× · PMID 39732160 · DOI 10.1016/j.jpeds.2024.114456
5. Who Still Gets Ligated? Reasons for Persistence of Surgical Ligation of the Patent Ductus Arteriosus Following Availability of Transcatheter Device Occlusion for Premature Neonates.
   Hoffmann JK, Khazal Z, Apers W, Sharma P, et al · · 2024 · cited 2× · PMID 38786954 · DOI 10.3390/jcdd11050132
6. Comparison of neurodevelopmental outcomes of extremely preterm infants undergoing trans-catheter closure of the patent ductus arteriosus compared to surgical ligation.
   Kaluarachchi DC, Chock VY, Do BT, Rysavy MA, et al · · 2026 · cited 1× · PMID 40987835 · DOI 10.1038/s41372-025-02417-8
7. PDA in Prematurity: Rethinking a Decades-Old Debate in 2026.
   Plessas-Azurduy P, Lapointe A, Spénard S, Shalish W, et al · · 2026 · PMID 41898223 · DOI 10.3390/biomedicines14030576
8. Beyond diameter: redefining echocardiography criteria in trials of early PDA therapy.
   Bischoff AR, Dias Maia P, McNamara PJ. · · 2026 · PMID 41361029 · DOI 10.1038/s41372-025-02523-7