AMPLATZER Duct Occluder II Additional Sizes

Status:	Recruiting
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	Any
Updated:	10/19/2018
Start Date:	June 5, 2017
End Date:	June 2021
Contact:	Kimberly Behning
Email:	kbehning@sjm.com
Phone:	651-756-5622

AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) Clinical Study

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.

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

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

We found this trial at

sites

Arnold Palmer Hospital

Orlando, Florida 32806

Principal Investigator: David Nykanen, MD

Phone: 321-841-5365

from

Orlando, FL