Patent Ductus Arteriosus (PDA)PREEMIENCT06587282
PREEMIE: Study for Treatment of PDA in Premature Infants
A study testing Bloom Micro Occluder System in people with Patent Ductus Arteriosus (PDA), run by Merit Medical Systems, Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 days and older
- Conditions the study is for
- Patent Ductus Arteriosus (PDA)
- What is being tested?
- Bloom Micro Occluder System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 9 sitesUnited States
- Study dates
- 6 Mar 2025to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
UT Southwestern Medical Center
Dallas, Texas, 75390
Memorial Healthcare System-Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Nicklaus Children's Hospital
Miami, Florida, 33155
Herma Heart Institute-Children's Wisconsin
Milwaukee, Wisconsin, 53226
UC Davis Health
Sacramento, California, 95817
UC San Diego-Rady Children's Hospital
San Diego, California, 92123
Washington University-St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Multicenter, Single Arm Prospective, Non-Randomized Study 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 (PREEMIE)
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.
- Conditions
- Patent Ductus Arteriosus (PDA)
- Being tested
- Bloom Micro Occluder System
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bloom Micro Occluder SystemDevice
Percutaneous transcatheter closure of PDA using Bloom Micro Occluder System
| Study group | Role | What they receive |
|---|---|---|
| PDA treatment | Experimental | PDA treated with Bloom Micro Occluder System Receives: Device: Bloom Micro Occluder System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint
Composite rate of device-related Major Adverse Events (MAE) of interest through 30 days following the index procedure.
Measured: 30 days
Effectiveness Endpoint
The rate of Clinical Success achieved at the 6-month follow-up visit.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start6 Mar 2025
- Primary completionNov 2026 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus Arteriosus (PDA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howaida El-Said, MD, Principal investigator, Rady Children's Hospital, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587282
- Sponsor's protocol ID
- PDA-P3-23-01
- Acronym
- PREEMIE
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Single Arm Prospective, Non-Randomized Study 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 (PREEMIE)
- ClinicalTrials.gov ID
- NCT06587282
- Acronym / sponsor ID
- PREEMIE / PDA-P3-23-01
- Conditions
- Patent Ductus Arteriosus (PDA)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDA treatment | Experimental | Device: Bloom Micro Occluder SystemPDA treated with Bloom Micro Occluder System |
Who may qualify
- Ages
- 5 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bloom Micro Occluder SystemPercutaneous transcatheter closure of PDA using Bloom Micro Occluder System | Device | PDA treatment |
Primary outcome
Safety Endpoint
Time frame: 30 days
Composite rate of device-related Major Adverse Events (MAE) of interest through 30 days following the index procedure.
Effectiveness Endpoint
Time frame: 6 Months
The rate of Clinical Success achieved at the 6-month follow-up visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howaida El-Said, MD principal investigator
Rady Children's Hospital, San Diego
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bloom Micro Occluder System in people with Patent Ductus Arteriosus (PDA), run by Merit Medical Systems, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.