Transcatheter PDA Closure for Patent Ductus Arteriosus
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to confirm the safety and effectiveness of the Amplatzer Piccolo Occluder device for closing the patent ductus arteriosus (PDA) in premature infants in real-world settings. PDAs are blood vessels that should close after birth, but sometimes they remain open, leading to heart and lung issues. The study will collect data from infants under 2 kg with a PDA that requires closure based on their doctor's recommendation. Ideal participants are those diagnosed with a PDA who weigh less than 2 kg but at least 700 grams. As a Phase 4 trial, this study focuses on understanding how the FDA-approved device benefits more patients, ensuring its effectiveness and safety in broader real-world use.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for the Amplatzer Piccolo Occluder device?
Research has shown that the Amplatzer Piccolo Occluder device is generally safe for young infants requiring a heart procedure called PDA closure. Studies indicate a high success rate of over 99% when using this device in infants weighing less than 2 kg, with most procedures completed without major issues.
The device has been tested on many patients and has demonstrated effective results with minimal problems. Some lab tests have confirmed that the materials used in the device, such as nickel-titanium alloy, are generally safe, supporting its well-tolerated use in real-world settings.
Overall, the Amplatzer Piccolo Occluder has a strong safety record, making it a reliable option for tiny patients with heart concerns.12345Why are researchers enthusiastic about this study treatment?
The Amplatzer Piccolo Occluder device is unique because it offers a minimally invasive approach to treating patent ductus arteriosus (PDA), a condition commonly addressed through surgery or medication. Unlike traditional surgical methods, this device can be delivered via a catheter, which significantly reduces recovery time and hospital stays. Researchers are excited about this treatment because it can be used in even the tiniest of patients, including premature infants, offering a safer and more effective alternative to current options.
What evidence suggests that the Amplatzer Piccolo Occluder device is effective for PDA closure in premature infants?
Research has shown that the Amplatzer Piccolo Occluder device effectively closes a heart condition called patent ductus arteriosus (PDA) in premature babies. Studies have found that it successfully closes PDA in most cases and carries a low risk of serious complications. Specifically, more than 95% of babies survive three years after the procedure. This device provides a non-surgical option for closing PDA, which is particularly beneficial for the smallest and most delicate newborns. Overall, the evidence supports its effectiveness and safety for treating PDA in premature infants.16789
Who Is on the Research Team?
Shyam Sathanandam, MD
Principal Investigator
National Principal Investigator
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Transcatheter device closure of the PDA using the Amplatzer Piccolo Occluder device in premature infants less than 2kg
Follow-up
Participants are monitored for safety and effectiveness after the procedure, including assessments for effective PDA closure and potential complications
What Are the Treatments Tested in This Trial?
Interventions
- Amplatzer Piccolo Occluder device
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants will have the same data collected at the same time points.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Le Bonheur 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
Citations
3-year follow-up of a prospective, multicenter study of the ...
This follow-up study demonstrates high rates of PDA closure, low serious complication rates, and survival > 95% at 3 years. The Amplatzer ...
3-year follow-up of a prospective, multicenter study of the ...
Conclusions: This follow-up study demonstrates high rates of PDA closure, low serious complication rates, and survival > 95% at 3 years. The Amplatzer Piccolo™ ...
3.
abbott.mediaroom.com
abbott.mediaroom.com/2022-09-08-Three-Year-Data-on-Worlds-Smallest-Heart-Device-Show-Benefits-of-Fixing-Holes-in-Newborn-Hearts-Without-SurgeryThree-Year Data on World's Smallest Heart Device Show ...
The data confirm that the Amplatzer Piccolo Occluder can offer high success rates in terms of PDA closure while offering low adverse event rates ...
Summary of Safety and Effectiveness Data - accessdata.fda.gov
Purpose: The purpose of the trial was to evaluate the safety and effectiveness of the. AMPLATZER Duct Occluder for the non-surgical closure of patent ductus ...
5.
chla.org
chla.org/blog/experts/research-and-breakthroughs/does-piccolo-pda-closure-improve-outcomes-babiesDoes Piccolo PDA Closure Improve Outcomes for Babies?
A new clinical trial aims to shed light on how to best treat a patent ductus arteriosus in the most fragile infants.
6.
structuralheart.abbott
structuralheart.abbott/products/pda-closure-device/amplatzer-duct-occluder/amplatzer-duct-occluder-piccolo/clinical-dataAmplatzer Piccolo Occluders Clinical Data
Clinical data for the Amplatzer Piccolo Occluder shows significant implant success and effective closure for young infants and up.
7.
cardiovascular.abbott
cardiovascular.abbott/us/en/hcp/products/structural-heart/structural-interventions/amplatzer-pda.htmlAmplatzer Duct Occluders for PDA Closure
The Amplatzer Piccolo™ Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).
Amplatzer Piccolo Occluder Helps Babies' Hearts
The AMPLATZER PiccoloTM Occluder contains nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated ...
3-year follow-up of a prospective, multicenter study of the ...
Transcatheter closure of the PDA in pediatric patients with the Amplatzer Piccolo™ Occluder is safe and effective with > 99% procedural success in patients ≤ 2 ...
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