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This study is for patients who have been diagnosed with either a Patent Foramen Ovale [PFO] or an Atrial Septal Defect [ASD]. These are a type of hole located in the wall that separates the top two (2) chambers of the heart. You have been recommended to receive an atrial septal occluder device [a device specifically designed to close PFOs and ASDs] implanted in your heart to close this hole. Because these devices are made of materials that contain nickel, this trial is being conducted to perform blood nickel tests on those patients already referred for an atrial septal occluder device such as yourself. The purpose of this study is to compare levels of nickel in the blood in patients receiving either the Amplatzer or the Helex devices.
This is a single-center, single-operator, investigator-initiated, investigator-funded, open-label, non-randomized cohort study. Inclusion criteria include patients ≥18 years, secundum atrial septal defect (ASD) ≤1cm on transesophageal echocardiography or patent foramen ovale (PFO), without contraindications to antiplatelet and/or antithrombotic therapy, and suitable anatomy for device closure with one of the following: Amplatzer atrial septal occluder, Amplatzer Cribriform septal occluder, Amplatzer PFO occluder, or the Gore Helex septal occluder. After device implantation, routine clinical followup will be performed, including transthoracic echocardiography at 1 day, 1 month, and 6 months, and 48-Holter monitoring for arrhythmia at 1 month.
Research related study procedures are blood draws to measure nickel levels and a patient questionnaire about symptoms. Blood draws will be done at baseline [from the femoral venous sheath immediately prior to device implantation] and at one (1) day, one (1) month, three (3) months and six (6) months. The Questionnaire will be completed at one (1) month, three (3) months and six (6) months but can be done over the telephone if patient is having blood drawn at a lab closer to their home. Patient participation is complete after collection of the 6 month blood results and patient questionnaire.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Atrial Septal Defect
Placement of atrial septal occluder device, Placement of Atrial Septal Occluder Device, Amplatzer Closure Device, Helex Gore Occluder Device
University of Utah
Salt Lake City
University of Utah
Published on BioPortfolio: 2014-07-23T21:10:35-0400
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
The purpose of this study is to evaluate the long-term safety and efficacy of the GORE HELEX(tm) Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).
The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder / GORE® Septal Occluder plus antiplatelet medical management is safe an...
Prospective mono-center clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD)
This clinical trial is a multi center, prospective, randomized, parallel study designed to compare septal to apical ICD lead placement.
To evaluate the safety and feasibility of a modified poly(l-lactic acid) (PLLA) atrial septal defect (ASD) occluder.
Atrial septal communications (ASC) include atrial septal defects (ASD) and patent foramen ovale (PFO).
To study the feasibility of closure of large atrial septal defects (ASDs) using occluder devices >38 mm and assess the midterm complications.
Percutaneous left atrial appendage (LAA) closure (placement of an occluder to close the appendage) is a novel procedure for stroke prevention in patients suffering from atrial fibrillation. The closur...
Developmental abnormalities in any portion of the ATRIAL SEPTUM resulting in abnormal communications between the two upper chambers of the heart. Classification of atrial septal defects is based on location of the communication and types of incomplete fusion of atrial septa with the ENDOCARDIAL CUSHIONS in the fetal heart. They include ostium primum, ostium secundum, sinus venosus, and coronary sinus defects.
A CATHETER-delivered implant used for closing abnormal holes in the cardiovascular system, especially HEART SEPTAL DEFECTS; or passageways intentionally made during cardiovascular surgical procedures.
Rapid, irregular atrial contractions caused by a block of electrical impulse conduction in the right atrium and a reentrant wave front traveling up the inter-atrial septum and down the right atrial free wall or vice versa. Unlike ATRIAL FIBRILLATION which is caused by abnormal impulse generation, typical atrial flutter is caused by abnormal impulse conduction. As in atrial fibrillation, patients with atrial flutter cannot effectively pump blood into the lower chambers of the heart (HEART VENTRICLES).
A condition characterized by a combination of OSTIUM SECUNDUM ATRIAL SEPTAL DEFECT and an acquired MITRAL VALVE STENOSIS.
Gray matter structures of the telencephalon and limbic system in the brain, but containing widely varying definitions among authors. Included here is the cortical septal area, subcortical SEPTAL NUCLEI, and the SEPTUM PELLUCIDUM. Many authorities consider the septal region to be made up of the septal area and the septal nuclei, but excluding the septum pellucidum. (Anthoney, Neuroanatomy and the Neurologic Exam, 1994, pp485-489; NeuroNames, http://rprcsgi.rprc.washington.edu/neuronames/index.html (November 18, 1998)).
Cardiology is a specialty of internal medicine. Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...
Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...