Patent Ductus ArteriosusADO IINCT00713700

AMPLATZER Duct Occluder II Clinical Study

A study testing AMPLATZER Duct Occluder II in people with Patent Ductus Arteriosus, run by Abbott Medical Devices at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA. Read more about this study

Who is it for?: Ages 6 months to 18 years
Conditions the study is for: Patent Ductus Arteriosus
What is being tested?: AMPLATZER Duct Occluder II
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 192 participants
Where: 25 sitesUnited States
Study dates: Aug 2008to 5 Oct 2016
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 6 months to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Subject must have diagnosis of a PDA
Subject must have a PDA < 5.5mm in diameter by angiography
Subject must have a PDA < 12mm in length by angiography
Subject must have a PDA > 3mm in length by angiography
Subject/legally authorized representative must give consent to participate in the clinical study
Subject/legally authorized representative must consent to follow-up for the duration of the clinical study

Who cannot join

Subject must not be < 6 kilograms for the procedure
Subject must not be < 6 months of age
Subject must not be ≥ 18 years of age
Subject must not have a descending aorta < 10mm in diameter
Subject must not have a right to left shunt through the patent ductus arteriosus
Subject must not have PVR above 8 Woods units or a Rp/Rs >0.4

Show all 14Show fewer

Subject must not have intracardiac thrombus
Subject must not have additional cardiac anomalies requiring surgical or interventional correction
Subject must not have history of more than two lower respiratory infections within the last year (i.e., pneumonia)
Subject must not have active infection requiring treatment at the time of implant
Subject must not have contraindication to anticoagulation treatment
Female subjects of child bearing age must not be pregnant or desire to become pregnant within six months post implant*
Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints
If the subject desires to become pregnant after six months post-implant, further restriction is at the discretion of their physician.

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
The Children's Hospital - Denver
Aurora, Colorado, 80045
Children's Hospital Boston
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
The Children's Hospital at Cleveland Clinic
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas SW Medical Center
Dallas, Texas, 75235
Memorial Regional Hospital (Joe DiMaggio Children's Hospital)
Hollywood, Florida, 33021
Texas Children's Hospital
Houston, Texas, 77030-2399
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232-9119
Mount Sinai School of Medicine
New York, New York, 10029
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4399
Primary Children's Medical Center
Salt Lake City, Utah, 84113
Children's Hospital and Health Center
San Diego, California, 92123
University of California San Francisco Hospital
San Francisco, California, 94143-0544
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105-0371
Washington University School of Medicine
St Louis, Missouri, 63110
The Children's Hospital Montefiore
The Bronx, New York, 10467
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Alfred I. DuPont Hospital for Children -Nemours Cardiac Center
Wilmington, Delaware, 19803

Other trials in United States

About this study

Official title: Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II

The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.

Conditions: Patent Ductus Arteriosus
Being tested: AMPLATZER Duct Occluder II
Keywords: patent ductus arteriosus, PDA
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.

AMPLATZER Duct Occluder IIDevice
AMPLATZER Duct Occluder II

Study groups in NCT00713700
Study group	Role	What they receive
Device	Experimental	Not described Receives: Device: AMPLATZER Duct Occluder II

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.
The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure
SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event.
Measured: 180 days
The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.
The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively.
Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 20085 Oct 2016

First posted11 Jul 2008 (estimated)
Study startAug 2008
Primary completionOct 2011
Study completion5 Oct 2016

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.
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
Masking: None (open label)
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00713700
Sponsor's protocol ID: CL00233
Acronym: ADO II
Status last verified: Jan 2019
First submitted: 9 Jul 2008
Last updated: 4 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Congenital Heart Disease, Congenital Heart Disease (CHD)
Active, not recruiting
PREEMIE: Study for Treatment of PDA in Premature Infants
Patent Ductus Arteriosus (PDA)
Active, not recruitingObservational study
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
Patent Ductus Arteriosus
Active, not recruitingObservational study
PDA for Kidneys Study
Patent Ductus Arteriosus, Congenital Heart Disease
RecruitingPhase 2
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Patent Ductus Arteriosus After Premature Birth

All Patent Ductus Arteriosus trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II
ClinicalTrials.gov ID: NCT00713700
Acronym / sponsor ID: ADO II / CL00233
Conditions: Patent Ductus Arteriosus
Keywords: patent ductus arteriosus, PDA
Study type: Interventional
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Oct 2011 (actual)
Study completion: 5 Oct 2016 (actual)
First posted: 11 Jul 2008 (estimated)
Results: Posted 16 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Device	Experimental	Device: AMPLATZER Duct Occluder II

Who may qualify

Ages: 6 months to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Subject must have diagnosis of a PDA
Subject must have a PDA < 5.5mm in diameter by angiography
Subject must have a PDA < 12mm in length by angiography
Subject must have a PDA > 3mm in length by angiography
Subject/legally authorized representative must give consent to participate in the clinical study

Key exclusion criteria (14 listed)

Subject must not be < 6 kilograms for the procedure
Subject must not be < 6 months of age
Subject must not be ≥ 18 years of age
Subject must not have a descending aorta < 10mm in diameter
Subject must not have a right to left shunt through the patent ductus arteriosus

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
AMPLATZER Duct Occluder IIAMPLATZER Duct Occluder II	Device	Device

Primary outcome

The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.
Time frame: 180 days
The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event.
The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.
Time frame: 180 days
The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively.

Results and safety

Results posted to the registry on 16 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Device	192	188

Primary outcome: The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.

Time frame: 180 days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Device n = 188
Value	1.6 (.33 to 4.59)

Population analysed: Of the 192 enrolled subjects, 188 completed follow-up through 180 days post procedure;3 subjects were lost to follow-up (LTFU) before the 180-day interval and 1 subject was discontinued at the end of the 6-month visit without follow-up.

Primary outcome: The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.

Time frame: 180 days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Device n = 166
Value	98.19 (94.81 to 99.63)

Population analysed: Of the 192 enrolled, 178 subjects experienced successful device placement.Of the 178 subjects with the device implanted,166 had a 6-month TTE and physical examination before 200 days post procedure or had an explant before the 6-month follow-up interval ended.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Device	3 of 192 (1.6%)	19 of 192 (9.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Patent Ductus Arteriosus

Recruiting
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Congenital Heart Disease, Congenital Heart Disease (CHD)
Active, not recruiting
PREEMIE: Study for Treatment of PDA in Premature Infants
Patent Ductus Arteriosus (PDA)
Active, not recruitingObservational study
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
Patent Ductus Arteriosus
Active, not recruitingObservational study
PDA for Kidneys Study
Patent Ductus Arteriosus, Congenital Heart Disease
RecruitingPhase 2
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Patent Ductus Arteriosus After Premature Birth

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.

The record lists no contact. Use the official record to reach the sponsor.

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AMPLATZER Duct Occluder II in people with Patent Ductus Arteriosus, run by Abbott Medical Devices at 25 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 6 inclusion and 14 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 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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 16 Dec 2013). 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?

The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure. (time frame: 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 NCT00713700.

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 Feb 2019.