Clinical trial NCT03055858: AMPLATZER Duct Occluder II Additional Sizes
Official title: AMPLATZER Duct Occluder II Additional Sizes Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patent Ductus Arteriosus
Keywords: PDA
SJM-CIP-10171
ADO II AS
IDE
CAP
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: ADO II AS device
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a PDA
* PDA ≤ 4mm in diameter
* PDA ≥ 3mm in length
* Subject (or legally authorized representative) is willing to comply with all pre-procedure, post-procedure, and follow-up testing requirements and provides consent to participate in the clinical study

NOTE: This study is enrolling children and all local laws and governing IRB requirements will be followed for obtaining informed consent

Exclusion Criteria:

* Weight \< 700 grams at time of the procedure
* Age \< 3 days at time of procedure
* Coarctation of the aorta
* Left pulmonary artery stenosis
* Cardiac output that is dependent on right to left shunt through the patent ductus arteriosus due to pulmonary hypertension
* Intracardiac thrombus
* Active infection requiring treatment at the time of implant
* Female subjects of child bearing potential are either pregnant or desire to become pregnant within six months post implant
* Other disease process likely to limit survival to less than six (6) months
* Participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints

Primary outcomes:
measure: Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant
timeFrame: Through 180 days
measure: Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant
timeFrame: At the 6-month follow-up
Secondary outcomes:
measure: The Rate of Significant Obstruction of the Pulmonary Artery or Aorta
timeFrame: Through 6 month follow-up visit
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Orlando
country: United States
facility: Arnold Palmer Hospital
state: Florida
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: Methodist LeBonheur Healthcare
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Evan Zahn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.