Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Investigation on Early Detection and Active Management of Supra-ventricular Arrhythmia With Telecardiology

Conditions
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Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia

Intervention / Treatment
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* Other: Telecardiology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dual chamber pacemaker with activated Telecardiology CHAD2DS2-VASc score ≥ 2 Sinusal rhythm at enrollment Patient willing and able to comply with the protocol Patient has provided informed consent Men and women > 18 years-old Patients geographically stable Exclusion Criteria: Anticoagulation therapy Dual anti-platelet therapy Class I or class III anti-arrhythmic drugs Contraindication to antithrombotic therapy Participation in another clinical study Have a life expectancy < 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Patients will be followed by telecardiology. | Other: Telecardiology<br>* 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.<br>* Other names: Remote monitoring;|
| Active Comparator: Control<br>Patients will be followed in the conventional manner. They will be equipped with telecardiology but data will not be used for patient surveillance. | Other: Telecardiology<br>* 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.<br>* Other names: Remote monitoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse events related to supraventricular arrhythmia. | Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency | 12-month | 
| Atrial burden at the end of the study |  | 12-month | 
| Atrial burden related to time | In order to check if atrial burden is time-dependent. | 12-month | 
| Supraventricular arrhythmia prevalence | Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up. | 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). | 12-month | 
| Supraventricular arrhythmia symptoms score (via a questionnaire) | Questionnaire submitted to the patient at enrollment and at each follow-up visit. | 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. | at each follow-up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, supraventricular arrhythmia, antithrombotic treatment, antiarrhythmic drugs, medical reaction time, telecardiology, early detection, holters memories, Pacemaker