This study investigates if the early detection and treatment of supraventricular arrhythmia (SVA) may help to prevent the progression of the arrhythmia and improve the clinical outcome. The primary endpoint investigates the delay to implement treatment in two groups of patients : * Active group: Patients followed by telecardiology. * Control group: Patients followed in the conventional manner. It is assumed that the delay to implement treatment will be higher in the Control group.
Atrial fibrillation is the most commonly encountered sustained cardiac arrhythmia in medical practice and it is often associated with atrial flutter. In patients with the new pacemaker generation EVIA, the home-monitoring technology provides specific and clinical relevant notifications for detection of atrial arrhythmias. Combined with holters memories, this can help to optimize the treatment of supraventricular arrhythmia (SVA) such as atrial fibrillation or flutter. This study will compare in the two groups the delay to implement for the first time a treatment for the supraventricular arrhythmia (antiarrhythmic drugs and/or an antithrombotic treatment).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
602
Telecardiology will be switched on for both groups. For the Active group, all data will be transmitted to the physician. For the Control group, data will not be used for patients surveillance, only events regarding implant (Elective Replacement Indication) or events regarding data transmission missing will be generated and sent to the physician. A retrospective analysis will be performed at the end of the study to compare the results in the two groups.
CH Général d'Abbeville
Abbeville, France
CH du Pays d'Aix
Aix-en-Provence, France
CH de la région d'Annecy
Annecy, France
CH d'Argentueil
Argenteuil, France
CH d'ARRAS
Arras, France
CH d'AURILLAC
Aurillac, France
Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia.
Delay from enrollment until the next in-office follow-up during which the supraventricular arrhythmia is managed for the first-time.
Time frame: 12-month
Serious adverse events related to supraventricular arrhythmia.
Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency
Time frame: 12-month
Atrial burden at the end of the study
Time frame: 12-month
Atrial burden related to time
In order to check if atrial burden is time-dependent.
Time frame: 12-month
Supraventricular arrhythmia prevalence
Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up.
Time frame: 12-month
Number of patients with managed supraventricular arrhythmia
Number of patients with supraventricular arrhythmia and for whom the physician implemented an overall management strategy (antithrombotic and/or antiarrhythmic drugs).
Time frame: 12-month
Supraventricular arrhythmia symptoms score (via a questionnaire)
Questionnaire submitted to the patient at enrollment and at each follow-up visit.
Time frame: at each follow-up visit
Quality of Life (via the EQ-5D Questionnaire)
The general health perception of the patients will be asked for, via the standardized EuroQOL EQ-5D questionnaire. This questionnaire provides a descriptive profile covering five dimensions (mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression) as well as a self-rating score of the patient's own assessment of its heath status.
Time frame: at each follow-up visit
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CH d'AUXERRE
Auxerre, France
CH d'AVIGNON
Avignon, France
CH de Béziers
Béziers, France
CH de Blois
Blois, France
...and 47 more locations