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Nickel Allergy With Septal Closure Devices

2014-07-23 21:10:35 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Atrial Septal Defect

Intervention

Placement of atrial septal occluder device, Placement of Atrial Septal Occluder Device, Amplatzer Closure Device, Helex Gore Occluder Device

Location

University of Utah
Salt Lake City
Utah
United States
84132

Status

Recruiting

Source

University of Utah

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:35-0400

Clinical Trials [1513 Associated Clinical Trials listed on BioPortfolio]

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

Long-term Safety Study of the GORE HELEX(tm) 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).

GORE® HELEX® Septal Occluder / GORE® Septal Occluder for Patent Foramen Ovale (PFO) Closure in Stroke Patients - The Gore REDUCE Clinical Study

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...

Safety and Effectiveness Study of the Solysafe Septal Occluder

Prospective mono-center clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD)

Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads

This clinical trial is a multi center, prospective, randomized, parallel study designed to compare septal to apical ICD lead placement.

PubMed Articles [3708 Associated PubMed Articles listed on BioPortfolio]

Study of biodegradable occluder of atrial septal defect in a porcine model.

To evaluate the safety and feasibility of a modified poly(l-lactic acid) (PLLA) atrial septal defect (ASD) occluder.

Transcatheter closure of atrial septal communication: impact on P-wave dispersion, duration and arrhythmia in mid-term follow-up.

Atrial septal communications (ASC) include atrial septal defects (ASD) and patent foramen ovale (PFO).

Feasibility, safety and midterm follow-up of patients after nonsurgical closure of atrial septal defects using very large 40-46 mm nitinol septal occluders.

To study the feasibility of closure of large atrial septal defects (ASDs) using occluder devices >38 mm and assess the midterm complications.

Left atrial appendage segmentation from 3D CCTA images for occluder placement procedure.

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...

Late dislocation of an amplatzer septal occluder in the chordae tendineae of the tricuspid valve after failed transcatheter closure of atrial septal defect.

Medical and Biotech [MESH] Definitions

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)).

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