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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDA closure | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADO II AS (PDA closure) | Device | Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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). | At the 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
NOTE: This study is enrolling children and all local laws and governing IRB requirements will be followed for obtaining informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan Zahn, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Arnold Palmer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37587183 | Derived | 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. | |
| 32433821 |
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A total of 50 subjects were enrolled in the ADO II AS IDE study at 8 centers in the United States between 5 June 2017 and 25 January 2018. Following completion of enrollment in the IDE cohort, an additional 150 subjects were enrolled in the continued access protocol (CAP) between 26 March 2018 and 1 February 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | PDA Closure | ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PDA Closure | ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150). The analysis population included the subjects who were available at the time of evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | Through 180 days |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PDA Closure | ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ebony Kargbo | Abbott Laboratories | 612-209-8185 | Ebony.Kargbo@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2018 | Sep 18, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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ADO II AS device
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| Through 6 month follow-up visit |
| Orlando |
| Florida |
| 32806 |
| United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Methodist LeBonheur Healthcare | Memphis | Tennessee | 38105 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Derived |
| Sathanandam 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. |
| Missed Follow-Up Visits |
|
| Mean |
| Standard Deviation |
| months |
|
| Sex: Female, Male | The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The number of participants analyzed includes subjects who were available at that time of analysis | Count of Participants | Participants |
|
| Race (NIH/OMB) | The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PDA Length | The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150) | Mean | Standard Deviation | mm |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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). | The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150). The analysis population included the subjects who were available at the time of evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | At the 6-month follow-up |
|
|
|
| Secondary | 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:
| The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150). The analysis population included the subjects who were available at the time of evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | Through 6 month follow-up visit |
|
|
|
| 9 |
| 200 |
| 13 |
| 200 |
| 26 |
| 200 |
| Hemolysis | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Procedural Blood Loss | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Coarctation of Aorta | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Obstruction of The Aorta | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pulmonary Hypertension | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Desaturation | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Device Migration | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Death Related to Liver Failure and Chronic Lung Disease | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Progressive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory Compromise | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Necrotizing Enterocolitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bleeding | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Device Embolization | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Stroke | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Left Vocal Cord Paralysis | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Device Embolization | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory Compromise | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Anemia Requiring Transfusion | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hoarse Cry | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Tissue from Left Side of Atrial Septum | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hematoma | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypotension | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Obstruction of The Pulmonary Artery | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Thrombus | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Valve Damage | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Valvular Regurgitation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vascular Occlusion | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vessel Damage | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Deterioration in Resp Status | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Right bundle branch block | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
|
| Black or African American |
|
| White |
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| More than one race |
|
| Unknown or Not Reported |
|
|
|