N/A
Completed N=192
AMPLATZER Duct Occluder II Clinical Study
Source: ClinicalTrials.gov NCT00713700 ↗Enrolled (actual)
192
Serious AEs
1.6%
Results posted
Dec 2013
Primary outcomePrimary: The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure. — 1.6 percentage of participants
Summary
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure. |
1.6 | — |
| PRIMARY The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up. |
98.19 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must have diagnosis of a PDA
- 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 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.
Data sourced from ClinicalTrials.gov (NCT00713700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.