Patent Ductus ArteriosusADO II ASNCT03055858
AMPLATZER Duct Occluder II Additional Sizes
A study testing ADO II AS (PDA closure) in people with Patent Ductus Arteriosus, run by Abbott Medical Devices at 9 sites in United States.
Trial summary
The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA). Read more about this study
- Who is it for?
- Ages 3 days and older
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- ADO II AS (PDA closure)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesUnited States
- Study dates
- 5 Jun 2017to 5 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of a PDA
- PDA ≤ 4mm in diameter
- PDA ≥ 3mm in length
- Subject (or legally authorized representative) is willing to comply with all pre-procedure, post-procedure, and follow-up testing requirements and provides consent to participate in the clinical study
- NOTE: This study is enrolling children and all local laws and governing IRB requirements will be followed for obtaining informed consent
Who cannot join
- Weight < 700 grams at time of the procedure
- Age < 3 days at time of procedure
- Coarctation of the aorta
- Left pulmonary artery stenosis
- Cardiac output that is dependent on right to left shunt through the patent ductus arteriosus due to pulmonary hypertension
- Intracardiac thrombus
Show all 10Show fewer
- Active infection requiring treatment at the time of implant
- Female subjects of child bearing potential are either pregnant or desire to become pregnant within six months post implant
- Other disease process likely to limit survival to less than six (6) months
- Participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Hospital of Michigan
Detroit, Michigan, 48201
Texas Children's Hospital
Houston, Texas, 77030
Cedars Sinai Medical Center
Los Angeles, California, 90048
Methodist LeBonheur Healthcare
Memphis, Tennessee, 38105
Arnold Palmer Hospital
Orlando, Florida, 32806
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Seattle Children's Hospital
Seattle, Washington, 98105
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: AMPLATZER Duct Occluder II Additional Sizes Clinical Study
The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance.
To account for subject dropout, up to 50 subjects will be enrolled in this clinical investigation. Up to an additional 150 subjects may be enrolled under continued access. The clinical investigation will be conducted at up to 10 centers in the United States.
Subjects participating in this clinical investigation will be followed for 3 years. The expected duration of enrollment is 18 months. The total duration of the clinical investigation is expected to be 4.5 years.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- ADO II AS (PDA closure)
- Keywords
- PDA, SJM-CIP-10171, ADO II AS, IDE, CAP
- 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.
ADO II AS (PDA closure)Device
Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
| Study group | Role | What they receive |
|---|---|---|
| PDA closure | Experimental | Not described Receives: Device: ADO II AS (PDA closure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant
Major complications are defined as device (ADO II AS) or procedure-related adverse events resulting in any of the following:
- death,
- life-threatening adverse event,
- persistent or significant disability/incapacity, and/or
- a major open surgical intervention which is performed by a surgeon under general anesthesia
Measured: Through 180 days
Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant
The primary effectiveness endpoint is the rate of effective closure of the ductus arteriosus among subjects with a successful ADO II AS implant as assessed by the presence of either a Grade 0 (none) or Grade 1 (trivial) shunt at the 6-month follow-up by transthoracic echocardiography (TTE).
Measured: At the 6-month follow-up
Secondary outcomes (1)
The Rate of Significant Obstruction of the Pulmonary Artery or Aorta
The rate of significant obstruction of the pulmonary artery or aorta through the 6-month follow-up visit per the following definitions:
- Significant obstruction of the left pulmonary artery is defined as less than 30% flow to the left lung by lung perfusion scan or a peak instantaneous gradient in left pulmonary artery ≥35 mmHg by echocardiogram if lung perfusion scan is not available. OR
- Significant obstruction of the aorta is defined as a gradient of ≥20 mmHg in the aortic isthmus by invasive aortic catheterization or a mean gradient ≥20 mmHg in the aortic isthmus by echocardiogram if invasive aortic catheterization is not available.
Measured: Through 6 month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start5 Jun 2017
- Primary completion25 Sep 2019
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- ADO II AS device
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Evan Zahn, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055858
- Sponsor's protocol ID
- SJM-CIP-10171
- Acronym
- ADO II AS
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2017
- Last updated
- 11 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Morray BH, Sathanandam SK, Forbes T, Gillespie M, Berman D, Armstrong AK, Shahanavaz S, Jones T, Rockefeller T, Justino H, Nykanen D, Weiler C, Gutfinger D, Zahn EM. 3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo Occluder for transcatheter patent ductus arteriosus closure in children >/= 700 grams. J Perinatol. 2023 Oct;43(10):1238-1244. doi: 10.1038/s41372-023-01741-1. Epub 2023 Aug 16.
PubMed 37587183Sathanandam SK, Gutfinger D, O'Brien L, Forbes TJ, Gillespie MJ, Berman DP, Armstrong AK, Shahanavaz S, Jones TK, Morray BH, Rockefeller TA, Justino H, Nykanen DG, Zahn EM. Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients >/=700 grams. Catheter Cardiovasc Interv. 2020 Nov;96(6):1266-1276. doi: 10.1002/ccd.28973. Epub 2020 May 20.
PubMed 32433821
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMPLATZER Duct Occluder II Additional Sizes Clinical Study
- ClinicalTrials.gov ID
- NCT03055858
- Acronym / sponsor ID
- ADO II AS / SJM-CIP-10171
- Conditions
- Patent Ductus Arteriosus
- Keywords
- PDA, SJM-CIP-10171, ADO II AS, IDE, CAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Posted 5 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance.
To account for subject dropout, up to 50 subjects will be enrolled in this clinical investigation. Up to an additional 150 subjects may be enrolled under continued access. The clinical investigation will be conducted at up to 10 centers in the United States.
Subjects participating in this clinical investigation will be followed for 3 years. The expected duration of enrollment is 18 months. The total duration of the clinical investigation is expected to be 4.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ADO II AS device
| Arm | Type | Receives |
|---|---|---|
| PDA closure | Experimental | Device: ADO II AS (PDA closure) |
Who may qualify
- Ages
- 3 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of a PDA
- PDA ≤ 4mm in diameter
- PDA ≥ 3mm in length
- Subject (or legally authorized representative) is willing to comply with all pre-procedure, post-procedure, and follow-up testing requirements and provides consent to participate in the clinical study
- NOTE: This study is enrolling children and all local laws and governing IRB requirements will be followed for obtaining informed consent
Key exclusion criteria (10 listed)
- Weight < 700 grams at time of the procedure
- Age < 3 days at time of procedure
- Coarctation of the aorta
- Left pulmonary artery stenosis
- Cardiac output that is dependent on right to left shunt through the patent ductus arteriosus due to pulmonary hypertension
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 |
|---|---|---|
| ADO II AS (PDA closure)Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS). | Device | PDA closure |
Primary outcome
Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant
Time frame: Through 180 days
Major complications are defined as device (ADO II AS) or procedure-related adverse events resulting in any of the following: * death, * life-threatening adverse event, * persistent or significant disability/incapacity, and/or * a major open surgical intervention which is performed by a surgeon under general anesthesia
Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant
Time frame: At the 6-month follow-up
The primary effectiveness endpoint is the rate of effective closure of the ductus arteriosus among subjects with a successful ADO II AS implant as assessed by the presence of either a Grade 0 (none) or Grade 1 (trivial) shunt at the 6-month follow-up by transthoracic echocardiography (TTE).
1 secondary outcome
The Rate of Significant Obstruction of the Pulmonary Artery or Aorta
Time frame: Through 6 month follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37587183Morray BH, Sathanandam SK, Forbes T, Gillespie M, Berman D, Armstrong AK, Shahanavaz S, Jones T, Rockefeller T, Justino H, Nykanen D, Weiler C, Gutfinger D, Zahn EM. 3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo Occluder for transcatheter patent ductus arteriosus closure in children >/= 700 grams. J Perinatol. 2023 Oct;43(10):1238-1244. doi: 10.1038/s41372-023-01741-1. Epub 2023 Aug 16.
- Derived from this study: PubMed 32433821Sathanandam SK, Gutfinger D, O'Brien L, Forbes TJ, Gillespie MJ, Berman DP, Armstrong AK, Shahanavaz S, Jones TK, Morray BH, Rockefeller TA, Justino H, Nykanen DG, Zahn EM. Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients >/=700 grams. Catheter Cardiovasc Interv. 2020 Nov;96(6):1266-1276. doi: 10.1002/ccd.28973. Epub 2020 May 20.
- 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.
Evan Zahn, MD principal investigator
Cedars-Sinai Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADO II AS (PDA closure) in people with Patent Ductus Arteriosus, run by Abbott Medical Devices at 9 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 5 inclusion and 10 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 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Yes. Results are posted in the registry (first posted 5 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant (time frame: Through 180 days). 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 NCT03055858, 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 11 Feb 2025.