Atrial Septal Defect SecundumASO 522NCT02353351
ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study
An observational study of Atrial Septal Defect Secundum, run by Abbott Medical Devices at 65 sites in United States.
Trial summary
Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Septal Defect Secundum
- What is being tested?
- atrial septal occluder
- Type of treatment
- Medical device
- How many people
- 602 participants
- Where
- 65 sitesUnited States
- Study dates
- 19 Jan 2015to 24 Feb 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement). The subject population includes vulnerable patients.
Who may be able to join
- To participate in this clinical investigation, the patient must meet all of the following inclusion criteria:
- Patient indicated for ASD closure who has echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement) and is implanted with the ASO device Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure
- Patient is willing and able to complete the follow-up requirements of this study
- Patient signs the informed consent (or a legal representative signs the informed consent.)
Who cannot join
- Patient is not eligible for clinical investigation participation if he/she meets any of the following exclusion criteria:
- Patient is known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery
- Patient is known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement
- Patient is known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy (unless another anti-platelet agent can be administered for 6 months)
- Patient is known to have a demonstrated intracardiac thrombus on echocardiography
- Patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization
- Patient has margins of defect that are less than 5 mm to the coronary sinus, AV valves or right upper lobe pulmonary vein
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
United States65 sites
Albany Medical College
Albany, New York, 12208
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
North Austin Medical Center
Austin, Texas, 78758
University of Maryland
Baltimore, Maryland, 21201
University of Alabama
Birmingham, Alabama, 35294
Boston Children's Hospital
Boston, Massachusetts, 02115
Holy Spirit Hospital
Camp Hill, Pennsylvania, 17011
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Virginia
Charlottesville, Virginia, 22908
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
The Ohio State University
Columbus, Ohio, 43210
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Geisinger Medical Center
Danville, Pennsylvania, 17822
Children's Hospital of Michigan
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Hospital
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
East Carolina University
Greenville, North Carolina, 27834
Pinnacle Health
Harrisburg, Pennsylvania, 17101
Houston Methodist DeBakey Heart and Vascular Center
Houston, Texas, 77030
Texas Children's Hospital / Baylor College of Medicine
Houston, Texas, 77030
The University of Texas Health Science Center at Houston/Memorial Hermann Hospital
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Baptist Medical Center
Jacksonville, Florida, 32207
Sunrise Hospital
Las Vegas, Nevada, 89109
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Arkansas
Little Rock, Arkansas, 72202
Children's Hospital Los Angeles
Los Angeles, California, 90027
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
University of Southern California
Los Angeles, California, 90033
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Valley Children's Hospital
Madera, California, 93636
University of Wisconsin
Madison, Wisconsin, 53792
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
Yale New Haven Hospital
New Haven, Connecticut, 06504
Cohen Children's Medical Center
New Hyde Park, New York, 11040
Children's Hospital
New Orleans, Louisiana, 70118
New York Presbyterian/Cornell
New York, New York, 10021
Mount Sinai Hospital
New York, New York, 10029
Children's Hospital of New York - Presbyterian
New York, New York, 10032
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Florida Hospital Orlando
Orlando, Florida, 32803
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Stanford University Medical Center
Palo Alto, California, 94304
Huntington Memorial Hospital
Pasadena, California, 91105
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennslyvania
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Primary Children's Hospital
Salt Lake City, Utah, 84113
Rady Children's Hospital
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
University of Washington
Seattle, Washington, 98195
Providence Medical Research Group
Spokane, Washington, 99204
St. Louis Children's Hospital
St Louis, Missouri, 63110
All Children's Hospital
St. Petersburg, Florida, 33701
Tampa General Hospital
Tampa, Florida, 33609
University of Arizona
Tucson, Arizona, 85724
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Iowa Heart Center / Mercy Medical Center
West Des Moines, Iowa, 50266
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: Closure of Atrial Septal Defects With the AMPLATZER™ Septal Occluder (ASO) Post Market Surveillance Study
Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)
Read the detailed description
This study will enroll 8000 subjects. The sub-cohort will consist of 160 (2%) subjects, randomly selected from the full cohort. The analysis population will consist of all subjects in the sub-cohort, combined with all subjects with erosion events who are not in the sub-cohort. A detailed assessment of risk factors will be conducted on the subjects in this analysis population.
- Conditions
- Atrial Septal Defect Secundum
- Being tested
- atrial septal occluder
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atrial septal occluderDevice
Also called AMPLATZER Septal Occluder
Single arm atrial septal defect closure with the AMPLATZER Septal Occluder
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of cardiac erosion
Cumulative incidence of erosion will be reported as:
- The number of erosions per 8000 subjects.
Measured: 1 year
Secondary outcomes (15)
Aortic Rim Measurements (< 5 mm, ≥ 5 mm)
Measured: 1 year
Atrio-Ventricular (AV) Valve Rim Measurements (< 5 mm, ≥ 5 mm)
Measured: 1 year
Superior Vena Cava (SVC) Rim Measurements (< 5 mm, ≥ 5 mm)
Measured: 1 year
Inferior Vena Cava (IVC) Rim Measurements (< 5 mm, ≥ 5 mm)
Measured: 1 year
Other Evaluable Rim Measurements (< 5 mm, ≥ 5 mm)
Measured: 1 year
Ratio of Defect Size (Diameter) to Septal Length (< 0.5:1, ≥ 0.5:1)
Measured: 1 year
Ratio of Defect Size (Diameter) to Septal Width (< 0.5:1, ≥ 0.5:1)
Measured: 1 year
Device Splaying the Aorta (Yes, No)
Measured: 1 year
Device Impingement of the Aorta (Yes, No)
Measured: 1 year
Device Abutting the Aorta (Yes, No)
Measured: 1 year
Age (< 14, ≥ 14 years)
Measured: 1 year
Gender (Male, Female)
Measured: 1 year
Device Size Implanted (< 18 mm, ≥ 18 mm)
Measured: 1 year
Device Size to Defect Size (< 1.5:1, ≥ 1.5:1)
Measured: 1 year
Body Surface Area (<1.5 m2 and ≥ 1.5m2)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study start19 Jan 2015
- Primary completion24 Feb 2017
- Study completion24 Feb 2017
Why it stopped: The sponsor's study closure justification addressed the 522 Order's questions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal Defect SecundumStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashish Oza, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353351
- Sponsor's protocol ID
- PS130046
- Acronym
- ASO 522
- Status last verified
- Jan 2019
- First submitted
- 2 Dec 2014
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
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 Atrial Septal Defects With the AMPLATZER™ Septal Occluder (ASO) Post Market Surveillance Study
- ClinicalTrials.gov ID
- NCT02353351
- Acronym / sponsor ID
- ASO 522 / PS130046
- Conditions
- Atrial Septal Defect Secundum
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The sponsor's study closure justification addressed the 522 Order's questions.
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2015 (actual)
- Primary completion
- 24 Feb 2017 (actual)
- Study completion
- 24 Feb 2017 (actual)
- First posted
- 2 Feb 2015 (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.
Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)
Detailed description
This study will enroll 8000 subjects. The sub-cohort will consist of 160 (2%) subjects, randomly selected from the full cohort. The analysis population will consist of all subjects in the sub-cohort, combined with all subjects with erosion events who are not in the sub-cohort. A detailed assessment of risk factors will be conducted on the subjects in this analysis population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement). The subject population includes vulnerable patients.
Key inclusion criteria (4 listed)
- To participate in this clinical investigation, the patient must meet all of the following inclusion criteria:
- Patient indicated for ASD closure who has echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement) and is implanted with the ASO device Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure
- Patient is willing and able to complete the follow-up requirements of this study
- Patient signs the informed consent (or a legal representative signs the informed consent.)
Key exclusion criteria (7 listed)
- Patient is not eligible for clinical investigation participation if he/she meets any of the following exclusion criteria:
- Patient is known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery
- Patient is known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement
- Patient is known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy (unless another anti-platelet agent can be administered for 6 months)
- Patient is known to have a demonstrated intracardiac thrombus on echocardiography
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 |
|---|---|---|
| atrial septal occluderAlso: AMPLATZER Septal OccluderSingle arm atrial septal defect closure with the AMPLATZER Septal Occluder | Device | – |
Primary outcome
Cumulative incidence of cardiac erosion
Time frame: 1 year
Cumulative incidence of erosion will be reported as: • The number of erosions per 8000 subjects.
15 secondary outcomes
Aortic Rim Measurements (< 5 mm, ≥ 5 mm)
Time frame: 1 year
Atrio-Ventricular (AV) Valve Rim Measurements (< 5 mm, ≥ 5 mm)
Time frame: 1 year
Superior Vena Cava (SVC) Rim Measurements (< 5 mm, ≥ 5 mm)
Time frame: 1 year
Inferior Vena Cava (IVC) Rim Measurements (< 5 mm, ≥ 5 mm)
Time frame: 1 year
Other Evaluable Rim Measurements (< 5 mm, ≥ 5 mm)
Time frame: 1 year
Ratio of Defect Size (Diameter) to Septal Length (< 0.5:1, ≥ 0.5:1)
Time frame: 1 year
Ratio of Defect Size (Diameter) to Septal Width (< 0.5:1, ≥ 0.5:1)
Time frame: 1 year
Device Splaying the Aorta (Yes, No)
Time frame: 1 year
Device Impingement of the Aorta (Yes, No)
Time frame: 1 year
Device Abutting the Aorta (Yes, No)
Time frame: 1 year
Age (< 14, ≥ 14 years)
Time frame: 1 year
Gender (Male, Female)
Time frame: 1 year
Device Size Implanted (< 18 mm, ≥ 18 mm)
Time frame: 1 year
Device Size to Defect Size (< 1.5:1, ≥ 1.5:1)
Time frame: 1 year
Body Surface Area (<1.5 m2 and ≥ 1.5m2)
Time frame: 1 year
Results and safety
The study was stopped early (reason given: The sponsor's study closure justification addressed the 522 Order's questions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Related trials for Atrial Septal Defect Secundum
Not yet recruiting
Dapagliflozin and Right Heart Recovery After ASD Device Closure
ASD2(Secundum Atrial Septal Defect)
Active, not recruiting
Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD
Heart Septal Defect, Heart Septal Defects, Atrial
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.
Ashish Oza study director
Abbott Medical Devices
65 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Septal Defect Secundum, run by Abbott Medical Devices at 65 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 4 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: stopped early, 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 65 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 was stopped early (reason given: The sponsor's study closure justification addressed the 522 Order's questions.). Results are not available in the source record.
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?
Cumulative incidence of cardiac erosion (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.