AMPLATZER Duct Occluder II Additional Sizes (ADO II AS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03055858|
Recruitment Status : Active, not recruiting
First Posted : February 16, 2017
Last Update Posted : October 28, 2019
The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized, open-label study 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.
|Condition or disease||Intervention/treatment||Phase|
|Patent Ductus Arteriosus||Device: ADO II AS (PDA closure)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||ADO II AS device|
|Masking:||None (Open Label)|
|Official Title:||AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) Clinical Study|
|Actual Study Start Date :||June 5, 2017|
|Actual Primary Completion Date :||September 25, 2019|
|Estimated Study Completion Date :||February 2022|
|Experimental: PDA closure||
Device: ADO II AS (PDA closure)
Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
- Safety Endpoint: The rate of major complications after an attempted ADO II AS device implant [ Time Frame: Through 180 days ]The rate of major complications after an attempted ADO II AS device implant.
- Effectiveness Endpoint: 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 or Grade 1 shunt by transthoracic echocardiography. [ Time Frame: At the six-month follow-up ]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 or Grade 1 shunt by transthoracic echocardiography.
- Obstruction in left pulmonary artery or aorta: The rate of significant obstruction of the pulmonary artery or aorta [ Time Frame: Through 6 month follow-up visit ]The rate of significant obstruction of the pulmonary artery or aorta.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055858
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Florida|
|Arnold Palmer Hospital|
|Orlando, Florida, United States, 32806|
|United States, Michigan|
|Children's Hospital of Michigan|
|Detroit, Michigan, United States, 48201|
|United States, Missouri|
|St. Louis Children's Hospital|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|LeBonheur Children's Hospital|
|Memphis, Tennessee, United States, 38105|
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Evan Zahn, MD||Cedars-Sinai Medical Center|