PPC vs Observation for Patent Ductus Arteriosus in Infants
(PIVOTAL Trial)
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?
How is the PICCOLO Occluder treatment different from other treatments for patent ductus arteriosus in infants?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of cardiac function and neurodevelopmental outcomes.
Extension
Participants may continue to be monitored for long-term outcomes, including neurodevelopmental assessments and respiratory support requirements.
Treatment Details
Interventions
- PICCOLO
- Responsive Management Intervention
PICCOLO is already approved in United States, European Union for the following indications:
- Closure of patent ductus arteriosus in preterm infants
- 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
Abbott
Industry Sponsor
Dr. Etahn Korngold
Abbott
Chief Medical Officer
MD, Harvard Medical School
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
University of Bristol
Collaborator
Cedars-Sinai Medical Center
Collaborator
Children's Hospital Los Angeles
Collaborator
National Institutes of Health (NIH)
Collaborator
Dartmouth College
Collaborator
University of Pittsburgh
Collaborator
University of Iowa
Collaborator