AMPLATZER Duct Occluder II Additional Sizes

Patent Ductus Arteriosus Clinical Trial

— ADO II AS  

Official title:

AMPLATZER Duct Occluder II Additional Sizes Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055858
• Other study ID #: SJM-CIP-10171
• Status: Completed
• Phase: N/A
• Start date: June 5, 2017
• Est. completion date: April 5, 2022

Study information

• Verified date: November 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 5, 2022
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Days and older

Eligibility

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

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Device:
• ADO II AS (PDA closure)
Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Texas Children's Hospital	Houston	Texas
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Methodist LeBonheur Healthcare	Memphis	Tennessee
United States	Arnold Palmer Hospital	Orlando	Florida
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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: death,; life-threatening adverse event,; persistent or significant disability/incapacity, and/or; a major open surgical intervention which is performed by a surgeon under general anesthesia	Through 180 days
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).	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: Significant obstruction of the left pulmonary artery is defined as less than 30% flow to the left lung by lung perfusion scan or a peak instantaneous gradient in left pulmonary artery =35 mmHg by echocardiogram if lung perfusion scan is not available. OR; Significant obstruction of the aorta is defined as a gradient of =20 mmHg in the aortic isthmus by invasive aortic catheterization or a mean gradient =20 mmHg in the aortic isthmus by echocardiogram if invasive aortic catheterization is not available.	Through 6 month follow-up visit