240 Participants Needed

PPC vs Observation for Patent Ductus Arteriosus in Infants

(PIVOTAL Trial)

Recruiting at 19 trial locations
JS
CH
Overseen ByCarl H Backes
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Nationwide Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing whether using a small device called PICCOLO to close an abnormal heart opening in preterm infants with PDA is better than using medications. If successful, it could become the new standard treatment. A new method has been introduced as a possible treatment for PDA in premature infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment PICCOLO Occluder for Patent Ductus Arteriosus in infants?

Research shows that using the Amplatzer Piccolo Occluder for closing a patent ductus arteriosus (a heart condition where a blood vessel doesn't close properly after birth) in infants can improve breathing compared to surgery. A study also followed infants for three years after using this device and found it to be effective in closing the condition.12345

Is the Amplatzer Piccolo Occluder safe for closing patent ductus arteriosus in infants?

The Amplatzer Piccolo Occluder is generally safe for closing patent ductus arteriosus in infants, with a high success rate and low risk of complications. Some rare issues like device movement and minor vessel narrowing have been reported, but serious problems are uncommon.13678

How is the PICCOLO Occluder treatment different from other treatments for patent ductus arteriosus in infants?

The PICCOLO Occluder is unique because it allows for a minimally invasive procedure called transcatheter closure, which is less invasive than traditional surgery and can be performed on very small infants, even those weighing as little as 700 grams.124910

Eligibility Criteria

This trial is for preterm infants with Patent Ductus Arteriosus (PDA), a heart condition present at birth. Eligible infants must be in the NICU, on mechanical ventilation, and between 7-32 days old with a birth weight of ≥700 grams. They should have a specific PDA severity score on an echocardiogram but no chromosomal defects, neuromuscular disorders, congenital lung abnormalities or life-threatening conditions.

Inclusion Criteria

My baby can be enrolled in the study within 5 days of their heart test, and they are 7-32 days old.
My baby was born between 22 and 27 weeks of pregnancy.
You weighed at least 700 grams (about 1.5 pounds) at birth.
See 3 more

Exclusion Criteria

My infant is under a do not resuscitate order or we are considering limiting intensive care.
I have a genetic condition like Trisomy 18.
I have a blood clot in my heart that could affect medical device placement.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either Percutaneous Patent Ductus Arteriosus Closure (PPC) or Responsive Management. Those in the PPC group undergo active intervention, while those in the Responsive Management group receive supportive care.

Up to 36 weeks post-menstrual age

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cardiac function and neurodevelopmental outcomes.

4 months corrected age

Extension

Participants may continue to be monitored for long-term outcomes, including neurodevelopmental assessments and respiratory support requirements.

Up to 4 months corrected age

Treatment Details

Interventions

  • PICCOLO
  • Responsive Management Intervention
Trial OverviewThe study compares two treatments for PDA: percutaneous closure using the PICCOLO device versus supportive management with medications. It's designed to see which method is more effective for these low-weight infants and could potentially set new care standards.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Secondary InterventionExperimental Treatment2 Interventions
Sub-group of patients initially randomized to Responsive Management who may suffer a decline in health status that can be attributed to the presence of a hemodynamically significant patent ductus arteriosus (HSPDA). These patients, upon meeting pre-specified clinical criteria, will undergo active treatment via Percutaneous Patent Ductus Arteriosus Closure (PPC) as in the active comparator arm.
Group II: Primary ComparatorActive Control3 Interventions
Interventional groups that subject will be randomly assigned to include Percutaneous Patent Ductus Arteriosus Closure (PPC) or Responsive Management. Those assigned to PPC will undergo active intervention to close a hemodynamically significant patent ductus arteriosus (HSPDA) whereas those assigned to Responsive Management will be treated to manage the symptoms of the HSPDA and permit natural closure over time.

PICCOLO is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as PICCOLO Occluder for:
  • Closure of patent ductus arteriosus in preterm infants
🇪🇺
Approved in European Union as PICCOLO Occluder for:
  • Closure of patent ductus arteriosus in preterm infants

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials
354
Recruited
5,228,000+

Abbott

Industry Sponsor

Trials
760
Recruited
489,000+
Dr. Etahn Korngold profile image

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford profile image

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

University of Bristol

Collaborator

Trials
114
Recruited
25,030,000+

Cedars-Sinai Medical Center

Collaborator

Trials
523
Recruited
165,000+

Children's Hospital Los Angeles

Collaborator

Trials
257
Recruited
5,075,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Dartmouth College

Collaborator

Trials
93
Recruited
1,415,000+

University of Pittsburgh

Collaborator

Trials
1,820
Recruited
16,360,000+

University of Iowa

Collaborator

Trials
486
Recruited
934,000+

Findings from Research

Transcatheter closure of patent ductus arteriosus (PDA) using the Amplatzer Piccolo Occluder is safe and effective, with successful closure in all cases analyzed from 147 preterm infants.
Infants who underwent catheter closure had a shorter duration of mechanical ventilation (3 days) compared to those who had surgical closure (5 days), and those treated earlier (before 4 weeks of age) were discharged home sooner, indicating potential benefits of this less invasive approach.
Improved ventilation in premature babies after transcatheter versus surgical closure of patent ductus arteriosus.Regan, W., Benbrik, N., Sharma, SR., et al.[2021]
In a study of 408 infants weighing less than 6 kg who underwent transcatheter patent ductus arteriosus (PDA) closure, a high success rate of 92% was achieved without major complications, indicating that this procedure is safe for smaller patients.
While the procedure is effective, the study noted a higher embolization rate (5%) compared to larger patients, suggesting that careful assessment of duct morphology and device retrievability is crucial when considering transcatheter closure versus surgical options.
Outcome after transcatheter occlusion of patent ductus arteriosus in infants less than 6 kg: A national study from United Kingdom and Ireland.Kang, SL., Jivanji, S., Mehta, C., et al.[2018]
In a study of 201 premature infants with a patent ductus arteriosus (PDA), 47% experienced spontaneous closure by 12 months, and 58% by 18 months, indicating a significant rate of natural resolution over time.
The study also found that 8.4% of infants required assisted closure through surgical methods, and there was a notable incidence of serious adverse events, highlighting the need for careful monitoring of these infants after discharge.
Low Rate of Spontaneous Closure in Premature Infants Discharged with a Patent Ductus Arteriosus: A Multicenter Prospective Study.Tolia, VN., Powers, GC., Kelleher, AS., et al.[2022]

References

Improved ventilation in premature babies after transcatheter versus surgical closure of patent ductus arteriosus. [2021]
Outcome after transcatheter occlusion of patent ductus arteriosus in infants less than 6 kg: A national study from United Kingdom and Ireland. [2018]
Low Rate of Spontaneous Closure in Premature Infants Discharged with a Patent Ductus Arteriosus: A Multicenter Prospective Study. [2022]
3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo™ Occluder for transcatheter patent ductus arteriosus closure in children ≥ 700 grams. [2023]
Outcomes for Infants Born in Perinatal Centers Performing Fewer Surgical Ligations for Patent Ductus Arteriosus: A Swiss Population-Based Study. [2021]
Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams. [2021]
Percutaneous Closure of Patent Ductus Arteriosus in Infants 1.5 kg or Less: A Meta-Analysis. [2021]
Piccolo in transcatheter PDA closure multi-centre study from premature to adolescent children. [2023]
Spontaneous Closure of the Ductus Arteriosus in Preterm Infants: A Systematic Review. [2023]
Transjugular venous approach for Piccolo patent ductus arteriosus closure in a 1.4 kg infant. [2022]