Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker
Summary
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Pacemaker Indication
Intervention
EVIA Pacemaker
Location
CHU Bordeaux Haut-Lévêque
Pessac
Bordeaux
France
F - 33604
Status
Active, not recruiting
Source
Biotronik SE & Co. KG
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00916344
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cardiac Pacing, Artificial
Regulation of the rate of contraction of the heart muscles by an artificial pacemaker.
Pacemaker, Artificial
A device designed to stimulate, by electric impulses, contraction of the heart muscles. It may be temporary (external) or permanent (internal or internal-external).
Atrial Premature Complexes
A type of cardiac arrhythmia with premature atrial contractions or beats caused by signals originating from ectopic atrial sites. The ectopic signals may or may not conduct to the HEART VENTRICLES. Atrial premature complexes are characterized by premature P waves on ECG which are different in configuration from the P waves generated by the normal pacemaker complex in the SINOATRIAL NODE.
Parasystole
A cardiac arrhythmia that is caused by interaction of two independently initiated cardiac impulses of different rates from two separate foci. Generally one focus is the SINOATRIAL NODE, the normal pacemaker. The ectopic focus is usually in the HEART VENTRICLE but can be in the HEART ATRIUM or the ATRIOVENTRICULAR NODE. Modulation of the parasystolic rhythm by the sinus rhythm depends on the completeness of entrance block surrounding the parasystolic focus.
Acrospiroma
A rare cutaneous tumor of eccrine sweat gland origin. It is most commonly found on the extremities and is usually benign. There is no indication that heredity or external agents cause these tumors.
Clinical Trials
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PubMed Articles
Pacemaker ECG Quiz No. 23 : Pacemaker malfunction or arrhythmia?
In a 69-year-old patient, a DDDR pacemaker was implanted for sinus node disease with syncope due to sinus arrest with pauses > 4 s. Programming was performed carefully including measures to prevent un...
Laparoscopic-Assisted Retrieval of Migrated Intra-Abdominal Pacemaker Generator.
A 5-year-old boy born with a congenital heart defect had insertion of an epicardial pacemaker that was found on routine evaluation to have been displaced into the rectovesical pouch. He underwent tran...
Optogenetic control of cardiac function.
The cardiac pacemaker controls the rhythmicity of heart contractions and can be substituted by a battery-operated device as a last resort. We created a genetically encoded, optically controlled pacema...
Pacemaker ECG quiz no. 25 : Loss of stimulation of an AAI pacemaker in a soporous female patient
Scientific results of the pacemaker register : Possibilities and limits.
The German obligatory external quality assurance for pacemaker implantation generates a large database giving an almost complete review of in-patient pacemaker interventions since 2001. Publications o...
