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Active, not recruitingNCT06587282PREEMIEUpdated Oct 7, 2026

PREEMIE: Study for Treatment of PDA in Premature Infants

An interventional study of Bloom Micro Occluder System in Patent Ductus Arteriosus (PDA), sponsored by Merit Medical Systems, Inc.. Active, not recruiting at 9 sites in United States. Open to participants aged 5 Days and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Merit Medical Systems, Inc. · Not applicable, Interventional, and Treatment

Updated Oct 7, 2026Primary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
5 Days and older
Sex
All
01

Study summary

This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants over a period of 6 months.

02

Conditions studied

  • Patent Ductus Arteriosus (PDA)
03

In context

Ductus Arteriosus, Patent

146 studies on the registry are indexed under Ductus Arteriosus, Patent; 21 are open to participants now.

This study's planned enrollment of 55 is below the median of 80 across 80 interventional studies indexed under Ductus Arteriosus, Patent.

Browse Ductus Arteriosus, Patent studies →

Lead sponsor

Merit Medical Systems, Inc. is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Browse Merit Medical Systems, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Days and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject is age ≥5 days at time of enrollment.
  • Subject has a diagnosis of a hemodynamically significant patent ductus arteriosus (PDA) requiring closure.
  • Subject has a PDA is ≤4.0 mm in diameter.
  • Subject has a PDA is ≥5 mm in length.
  • Subject's weight is between 600-2500 grams at time of enrollment.

Exclusion criteria

Exclusion Criteria:

  • Subject has pre-existing coarctation of the aorta.
  • Subject has pre-existing left pulmonary artery stenosis.
  • Subject has an Intracardiac thrombus that may interfere with the implant procedure
  • Subject has other known hemodynamically significant congenital heart disease conditions at time of enrollment requiring intervention
  • Subject has an active systemic infection at the time of enrollment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • Experimental
    PDA treatment

    PDA treated with Bloom Micro Occluder System

    Device: Bloom Micro Occluder System

Interventions

  • DeviceBloom Micro Occluder System

    Percutaneous transcatheter closure of PDA using Bloom Micro Occluder System

06

What researchers measure

Primary outcomes

  1. Safety Endpoint

    Composite rate of device-related Major Adverse Events (MAE) of interest through 30 days following the index procedure.

    Time frame: 30 days

  2. Effectiveness Endpoint

    The rate of Clinical Success achieved at the 6-month follow-up visit.

    Time frame: 6 Months

07

Study locations

9 sites
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Mar 2025 (actual). Primary completion is estimated for Nov 2026, 20 months after the start.

Primary completion moved once since we started tracking on Sep 25, 2026: Aug 2026 → Nov 2026, on Oct 7, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2024
First posted
Sep 19, 2024
StartActual
Mar 6, 2025
Primary completionEst.
Nov 2026was Aug 2026
CompletionEst.
Mar 2029
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Aug 2026→Nov 2026
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Primary completion Aug 2026→Nov 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06587282
Lead sponsor
Merit Medical Systems, Inc.
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Mar 6, 2025
Primary completion
Nov 2026 (estimated)
Completion
Mar 2029 (estimated)
Last update
Oct 7, 2026

Study contacts

Howaida El-Said, MD
principal investigator · Rady Children's Hospital, San Diego

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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