Bloom Micro Occluder System for Patent Ductus Arteriosus

(PREEMIE Trial)

Recruiting at 8 trial locations

Overseen By Vicky Brunk

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Merit Medical Systems, Inc.

Disqualifiers: Coarctation of aorta, Pulmonary stenosis, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

55 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Bloom Micro Occluder System treatment for Patent Ductus Arteriosus?

The research on similar devices, like the Occlutech Duct Occluder, shows that these types of treatments can effectively close the patent ductus arteriosus (a heart defect) without surgery, providing immediate and short-term positive results. ^{1 2 3 4 5}

How is the Bloom Micro Occluder System treatment different from other treatments for patent ductus arteriosus?

The Bloom Micro Occluder System is unique because it is designed for transcatheter occlusion (blocking a blood vessel using a tube inserted through the skin) of the patent ductus arteriosus, offering a minimally invasive alternative to surgery. This system may provide a novel approach compared to other devices like coils or plugs, potentially improving ease of use and patient outcomes. ^{1 2 6 7 8}

What is the purpose of this trial?

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.

Research Team

Howaida El-Said, MD

Principal Investigator

Rady Children's Hospital

Eligibility Criteria

This trial is for premature infants at least 5 days old, diagnosed with a significant PDA (a heart issue where a blood vessel doesn't close after birth) that needs closing. The PDA must be less than or equal to 4mm wide and at least 5mm long. Infants must weigh between 600-2500 grams.

Inclusion Criteria

My pancreatic duct is 5 mm or longer.

My PDA is 4.0 mm or smaller in diameter.

My weight is between 600 and 2500 grams.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA)

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 visit (in-person) at 6 months

Treatment Details

Interventions

• Bloom Micro Occluder System

Trial Overview The study tests the Bloom Micro Occluder System's safety and effectiveness in treating PDA in preemies over six months. It's a single-group study, meaning all participants receive the same treatment without comparison to another group or placebo.

Participant Groups

Group I: PDA treatment Experimental Treatment 1 Intervention

PDA treated with Bloom Micro Occluder System

Who Is Running the Clinical Trial?

Merit Medical Systems, Inc.

Lead Sponsor

Trials

35

Recruited

3,500+

References

1. England pubmed.ncbi.nlm.nih.gov

Transcatheter occlusion of the patent ductus arteriosus with Cook detachable coils. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Technology assessment of nonsurgical closure of patent ductus arteriosus: an evaluation of the clinical effectiveness and costs of a new medical device. [2012]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Is the new Occlutech duct occluder an appropriate device for transcatheter closure of patent ductus arteriosus? [2018]

4. United States pubmed.ncbi.nlm.nih.gov

The new occlutech duct occluder: immediate results, procedural challenges, and short-term follow-up. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of two transcatheter device strategies for occlusion of the patent ductus arteriosus. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Early experience with the Micro Plug Set for preterm patent ductus arteriosus closure. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Double-helix coil for occlusion of large patent ductus arteriosus: evaluation in a chronic lamb model. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Initial clinical experience with the Medtronic Micro Vascular Plug™ in transcatheter occlusion of PDAs in extremely premature infants. [2018]