AMPLATZER Duct Occluder II Clinical Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.

Official Title
-----------------
Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II

Conditions
-----------------
Patent Ductus Arteriosus

Intervention / Treatment
-----------------
* Device: AMPLATZER Duct Occluder II


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Subject must not be < 6 kilograms for the procedure Subject must not be < 6 months of age Subject must not be ≥ 18 years of age Subject must not have a descending aorta < 10mm in diameter Subject must not have a right to left shunt through the patent ductus arteriosus Subject must not have PVR above 8 Woods units or a Rp/Rs >0.4 Subject must not have intracardiac thrombus Subject must not have additional cardiac anomalies requiring surgical or interventional correction Subject must not have history of more than two lower respiratory infections within the last year (i.e., pneumonia) Subject must not have active infection requiring treatment at the time of implant Subject must not have contraindication to anticoagulation treatment Female subjects of child bearing age must not be pregnant or desire to become pregnant within six months post implant* 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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br> | Device: AMPLATZER Duct Occluder II<br>* AMPLATZER Duct Occluder II<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure. | 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. | 180 days | 
| The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up. | 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. | 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PDA, patent ductus arteriosus