Study for Atrial Fibrillation Reduction (SAFARI)
Summary
Atrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the heart, is the world’s most common kind of irregular heart beat. People with AF experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness. Although AF can occur in otherwise healthy people for no apparent reason, it is sometimes associated with high blood pressure, heart disease or lung problems. The purpose of the SAFARI trial is to study the effectiveness of pacing algorithms in the upper chamber of the heart for patients who have both AF and bradycardia (slow heart beat).
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Conditions
Atrial Fibrillation, Bradycardia
Intervention
Pacing Algorithms
Location
Yuma
Arizona
United States
Status
Completed
Source
Medtronic Cardiac Rhythm Disease Management
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00267137
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Atrial Flutter
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).
Digoxin
A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)
Sick Sinus Syndrome
A condition caused by dysfunctions related to the SINOATRIAL NODE including impulse generation (CARDIAC SINUS ARREST) and impulse conduction (SINOATRIAL EXIT BLOCK). It is characterized by persistent BRADYCARDIA, chronic ATRIAL FIBRILLATION, and failure to resume sinus rhythm following CARDIOVERSION. This syndrome can be congenital or acquired, particularly after surgical correction for heart defects.
Torsades De Pointes
A malignant form of polymorphic ventricular tachycardia that is characterized by HEART RATE between 200 and 250 beats per minute, and QRS complexes with changing amplitude and twisting of the points. The term also describes the syndrome of tachycardia with prolonged ventricular repolarization, long QT intervals exceeding 500 milliseconds or BRADYCARDIA. Torsades de pointes may be self-limited or may progress to VENTRICULAR FIBRILLATION.
Wandering Behavior
Moving oneself through space while confused or otherwise cognitively impaired. Patterns include akathisia, exhibiting neuroleptic-induced pacing and restlessness; exit seekers who are often newly admitted institution residents who try to open locked exit doors; self-stimulators who perform other activities such as turning doorknobs, in addition to continuous pacing; and modelers who shadow other pacers.
Clinical Trials
Atrial Pacing for Termination and Prevention of Atrial Fibrillation
Atrial fibrillation (AF) is the most common sustained arrhythmia and is associated with substantial morbidity and mortality. Present treatment strategies are aimed at termination of AF an...
Electrophysiologically Guided PAcing Site Selection Study
This study is a long-term, prospective, and controlled evaluation of the incidence of persistent atrial fibrillation (AF) in patients with severe intra-right atrial conduction delay paced...
Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of...
MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
The aim of this study is to test the impact of the managed ventricular pacing (MVP) mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical...
The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, sympto...
PubMed Articles
This study aims to observe the effects of ibutilide on canine cardiac pacing threshold and on induction rates of atrial fibrillation. Eighteen mongrel dogs were anesthetized and administrated with ibu...
BACKGROUND: Atrial fibrillation (AF) is associated with activity of renin-angiotensin-aldosterone system (RAAS). Reduction in renal noradrenaline spillover could be achieved after renal sympathetic de...
Use of transcutaneous external pacing during transvenous pacemaker implantation in dogs.
The aim of this retrospective study was to evaluate the utility of transcutaneous external pacing (TEP) during transvenous pacemaker implantation in dogs. Eighty-two pacemakers were implanted in 77 do...
Cardiac pacing is ineffective in obstructive sleep apnea (SA), but it can alleviate central SA/Cheyne-Stokes respiration (CSA) in patients with heart failure (HF). We examined whether overnight overdr...
An asymptomatic adolescent male athlete was incidentally found to have ventricular preexcitation on electrocardiogram during a sports preparticipation physical. A transesophageal electrophysiology stu...
