AMPLATZER Duct Occluder II Clinical Study
- Conditions
- Patent Ductus Arteriosus
- Interventions
- Device: AMPLATZER Duct Occluder II
- Registration Number
- NCT00713700
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
- 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
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Subject must not be < 6 kilograms for the procedure
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Subject must not be < 6 months of age
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Subject must not be ≥ 18 years of age
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Subject must not have a descending aorta < 10mm in diameter
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Subject must not have a right to left shunt through the patent ductus arteriosus
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Subject must not have PVR above 8 Woods units or a Rp/Rs >0.4
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Subject must not have intracardiac thrombus
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Subject must not have additional cardiac anomalies requiring surgical or interventional correction
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Subject must not have history of more than two lower respiratory infections within the last year (i.e., pneumonia)
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Subject must not have active infection requiring treatment at the time of implant
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Subject must not have contraindication to anticoagulation treatment
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Female subjects of child bearing age must not be pregnant or desire to become pregnant within six months post implant*
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Device AMPLATZER Duct Occluder II -
- Primary Outcome Measures
Name Time Method The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up. 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.
The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Alfred I. DuPont Hospital for Children -Nemours Cardiac Center
🇺🇸Wilmington, Delaware, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
The Children's Hospital Montefiore
🇺🇸Bronx, New York, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Memorial Regional Hospital (Joe DiMaggio Children's Hospital)
🇺🇸Hollywood, Florida, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas SW Medical Center
🇺🇸Dallas, Texas, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Children's Hospital and Health Center
🇺🇸San Diego, California, United States
University of California San Francisco Hospital
🇺🇸San Francisco, California, United States
The Children's Hospital - Denver
🇺🇸Aurora, Colorado, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
The Children's Hospital at Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Vanderbilt Children's Hospital
🇺🇸Nashville, Tennessee, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Children's Hospital and Regional Medical Center
🇺🇸Seattle, Washington, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States