RESPECT PFO Clinical Trial
Summary
The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Cryptogenic Stroke
Intervention
AMPLATZER PFO Occluder, Standard of Care - Medical Management
Location
University of Alabama
Birmingham
Alabama
United States
35294
Status
Recruiting
Source
AGA Medical Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00465270
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Patient Care Management
Generating, planning, organizing, and administering medical and nursing care and services for patients.
Emergency Treatment
First aid or other immediate intervention for accidents or medical conditions requiring immediate care and treatment before definitive medical and surgical management can be procured.
Case Management
A traditional term for all the activities which a physician or other health care professional normally performs to insure the coordination of the medical services required by a patient. It also, when used in connection with managed care, covers all the activities of evaluating the patient, planning treatment, referral, and follow-up so that care is continuous and comprehensive and payment for the care is obtained. (From Slee & Slee, Health Care Terms, 2nd ed)
Progressive Patient Care
Organization of medical and nursing care according to the degree of illness and care requirements in the hospital. The elements are intensive care, intermediate care, self-care, long-term care, and organized home care.
Practice Management
Business management of medical and dental practices that may include capital financing, utilization management, and arrangement of capitation agreements with other parties.
Clinical Trials
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and...
AMPLATZER Duct Occluder II Clinical Study
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
The Purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of migraine...
Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER
The purpose of this feasibility study is to investigate the safety of the AMPLATZER® Membranous VSD Occluder for the treatment of hemodynamically significant Perimembranous Ventricular Se...
PubMed Articles
The new Amplatzer duct occluder II: when is its use advantageous?
OBJECTIVES: To determine the safety and efficacy of the Amplatzer duct occluder and the Amplatzer duct occluder II in different types of arterial ducts, and to determine in which types of ducts the us...
Erosion of an amplatzer septal occluder device into the aortic root.
Atrial septal defects can be closed surgically or percutaneously. We report a patient who underwent percutaneous closure of an atrial septal defect with an Amplatzer septal occluder device (AGA Medica...
Background: Prevalence of patent foramen ovale (PFO) with detectable right-to-left shunt is higher in young adults with transient ischemic attack (TIA) and stroke compared to the general population. S...
Abstract Although wire device frame fracture associated with thrombus formation has been reported in some types of atrial septal defect occluders, it has not been detected in patients with Amplatzer d...
The transcatheter closure of patent ductus arteriosus (PDA) may cause more complications in small children. Amplatzer (St. Jude Medical, Plymouth, MN) has produces three types of devices for ductal oc...
