Nit-Occlud PDA Post-Approval Study
1 other identifier
observational
184
1 country
11
Brief Summary
The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and effectiveness of the device in the post-approval phase.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2014
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2014
CompletedFirst Posted
Study publicly available on registry
April 1, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2022
CompletedOctober 4, 2022
September 1, 2022
5.3 years
March 27, 2014
September 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of Serious Device and/or Procedure Related Adverse Events as a Measure of Safety
The primary safety endpoint is to demonstrate the 24-month serious device-related adverse event rate is no worse than the objective-performance criterion (OPC) of 1%.
24 months (2 year)
Rate of Complete PDA Closure as a Measure of Efficacy
The primary effectiveness endpoint is to demonstrate the 12-month (1 year) complete closure rate for the device is no worse than the OPC of 85%. The closure of the ductus arteriosus will be assessed by absence of residual flow at 12 months (1 year) by transthoracic echocardiogram with 2-D color flow mapping and pulse wave Doppler (ECHO).
12 months (1 year)
Secondary Outcomes (1)
Rate of Device and/or Procedure Related Adverse Events as a Measure of Safety
24 months (2 year)
Study Arms (1)
PDA Coil
Patients age 6 months to 21 years weighing \> 5kg with an angiographically confirmed PDA with a minimum diameter of \< 4 mm.
Interventions
The Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter \< 4 mm.
Eligibility Criteria
Patients age 6 months to 21 years weighing \>/= 5kg with an angiographically confirmed PDA with a minimum diameter of \<4 mm.
You may qualify if:
- Angiographically confirmed PDA with minimum diameter \< 4 mm.
- Weight is ≥ 5 kg.
- Age 6 months to 21 years.
You may not qualify if:
- Cardiac anomalies requiring surgery.
- Known bleeding or coagulation disorder.
- Febrile illness within 7 days of planned procedure.
- Pregnancy.
- Pulmonary hypertension with increased pulmonary vascular resistance (≥ 5 Wood Units).
- Hypersensitivity to contrast medium.
- Known nickel allergy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PFM Medical, Inclead
- Bright Research Partnerscollaborator
Study Sites (11)
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Kaiser Permanente
Los Angeles, California, 90027, United States
Children's Hospital of Central California
Madera, California, 93636, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55454, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Medical Center of Dallas
Dallas, Texas, 75235, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Related Publications (2)
Proposed standards for clinical evaluation of patent ductus arteriosus occlusion devices. Multiorganization Advisory Panel to FDA for Pediatric Cardiovascular Devices. Catheter Cardiovasc Interv. 2000 Nov;51(3):293-6. No abstract available.
PMID: 11066109BACKGROUNDKobayashi D, Salem MM, Forbes TJ, Gordon BM, Soriano BD, Dimas V, Goldstein BH, Owada C, Javois A, Bass J, Jones TK, Berman DP, Gillespie MJ, Moore JW, Levi DS. Results of the combined U.S. multicenter postapproval study of the Nit-Occlud PDA device for percutaneous closure of patent ductus arteriosus. Catheter Cardiovasc Interv. 2019 Mar 1;93(4):645-651. doi: 10.1002/ccd.27995. Epub 2018 Dec 3.
PMID: 30511498RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel S Levi, MD
UCLA Pediatric Cardiology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2014
First Posted
April 1, 2014
Study Start
August 1, 2014
Primary Completion
November 20, 2019
Study Completion
August 10, 2022
Last Updated
October 4, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share