Patent Ductus Arteriosus (PDA)NCT02100683
Nit-Occlud PDA Post-Approval Study
An observational study of Patent Ductus Arteriosus (PDA), run by PFM Medical, Inc at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Patent Ductus Arteriosus (PDA)
- What is being tested?
- PDA Coil
- Type of treatment
- Medical device
- How many people
- 184 participants
- Where
- 11 sitesUnited States
- Study dates
- Aug 2014to 10 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients age 6 months to 21 years weighing >/= 5kg with an angiographically confirmed PDA with a minimum diameter of <4 mm.
Who may be able to join
- Angiographically confirmed PDA with minimum diameter < 4 mm.
- Weight is ≥ 5 kg.
- Age 6 months to 21 years.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Medical Center of Dallas
Dallas, Texas, 75235
Children's Hospital of Michigan
Detroit, Michigan, 48201
Loma Linda University Medical Center
Loma Linda, California, 92354
Kaiser Permanente
Los Angeles, California, 90027
Children's Hospital of Central California
Madera, California, 93636
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55454
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
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.
- Conditions
- Patent Ductus Arteriosus (PDA)
- Being tested
- PDA Coil
- Keywords
- Occluder
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDA CoilDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PDA Coil | Patients age 6 months to 21 years weighing > 5kg with an angiographically confirmed PDA with a minimum diameter of < 4 mm. Receives: Device: PDA Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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).
Measured: 12 months (1 year)
Secondary outcomes (1)
Rate of Device and/or Procedure Related Adverse Events as a Measure of Safety
The secondary safety endpoint is to demonstrate that the rate of device-related adverse events reported through 24-months post procedure is no worse than 6% (OPC rate of 3% plus an added 3% margin).
Measured: 24 months (2 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startAug 2014
- Primary completion20 Nov 2019
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patent Ductus Arteriosus (PDA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- PFM Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Responsible party
- Sponsor
- Investigators
- Daniel S Levi, MD, Principal investigator, UCLA Pediatric Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100683
- Sponsor's protocol ID
- TP126
- Status last verified
- Sep 2022
- First submitted
- 27 Mar 2014
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 11066109Kobayashi 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.
PubMed 30511498
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nit-Occlud PDA Post-Approval Study
- ClinicalTrials.gov ID
- NCT02100683
- Acronym / sponsor ID
- TP126
- Conditions
- Patent Ductus Arteriosus (PDA)
- Keywords
- Occluder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- PFM Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Study start
- Aug 2014 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 1 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDA Coil | – | Device: PDA CoilPatients age 6 months to 21 years weighing > 5kg with an angiographically confirmed PDA with a minimum diameter of < 4 mm. |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients age 6 months to 21 years weighing >/= 5kg with an angiographically confirmed PDA with a minimum diameter of <4 mm.
Key inclusion criteria (3 listed)
- Angiographically confirmed PDA with minimum diameter < 4 mm.
- Weight is ≥ 5 kg.
- Age 6 months to 21 years.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDA CoilThe 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. | Device | PDA Coil |
Primary outcome
Rate of Serious Device and/or Procedure Related Adverse Events as a Measure of Safety
Time frame: 24 months (2 year)
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%.
Rate of Complete PDA Closure as a Measure of Efficacy
Time frame: 12 months (1 year)
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).
1 secondary outcome
Rate of Device and/or Procedure Related Adverse Events as a Measure of Safety
Time frame: 24 months (2 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Background: PubMed 11066109Proposed 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.
- Results publication: PubMed 30511498Kobayashi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel S Levi, MD principal investigator
UCLA Pediatric Cardiology
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus (PDA), run by PFM Medical, Inc at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Serious Device and/or Procedure Related Adverse Events as a Measure of Safety (time frame: 24 months (2 year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02100683, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.