PREEMIE: Study for Treatment of PDA in Premature Infants | NCT06587282

Studies
PREEMIE: Study for Treatment of PDA in Premature Infants

NCT06587282

Sponsor

Merit Medical Systems, Inc.

Status

Active, not recruiting

Last Update Posted

May 15, 2026Actual

Enrollment

55Estimated

Phase

Not Applicable

Conditions

Patent Ductus Arteriosus (PDA)

Interventions

Bloom Micro Occluder System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2025Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Mar 2029Estimated

First Submitted Date

Sep 5, 2024

First Submission Date that Met QC Criteria

Sep 5, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2026

Last Update Posted Date

May 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PDA treatment	Experimental	PDA treated with Bloom Micro Occluder System	Device: Bloom Micro Occluder System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bloom Micro Occluder System	Device	Percutaneous transcatheter closure of PDA using Bloom Micro Occluder System	PDA treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety Endpoint	Composite rate of device-related Major Adverse Events (MAE) of interest through 30 days following the index procedure.	30 days
Effectiveness Endpoint	The rate of Clinical Success achieved at the 6-month follow-up visit.	6 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Days

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Howaida El-Said, MD	Rady Children's Hospital, San Diego	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Health		Sacramento	California	95817	United States
UC San Diego-Rady Children's Hospital

Condition Browse Module

MeSH Terms

ID	Term
D004374	Ductus Arteriosus, Patent

Ancestor Terms

ID	Term
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided