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

Not Applicable

Completed

• Conditions: Atrial Flutter; Atrial Fibrillation; Atrial Tachycardia

• Registration Number: NCT01108692
• Lead Sponsor: Biotronik France

Brief Summary

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

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 Timeline

• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Study Start: 2010-07
• Primary Completion: 2013-07
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 602

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia.	12-month	Delay from enrollment until the next in-office follow-up during which the supraventricular arrhythmia is managed for the first-time.

Secondary Outcome Measures

Name	Time	Method
Atrial burden at the end of the study	12-month
Number of patients with managed supraventricular arrhythmia	12-month	Number of patients with supraventricular arrhythmia and for whom the physician implemented an overall management strategy (antithrombotic and/or antiarrhythmic drugs).
Serious adverse events related to supraventricular arrhythmia.	12-month	Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency
Atrial burden related to time	12-month	In order to check if atrial burden is time-dependent.
Supraventricular arrhythmia prevalence	12-month	Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up.
Supraventricular arrhythmia symptoms score (via a questionnaire)	at each follow-up visit	Questionnaire submitted to the patient at enrollment and at each follow-up visit.
Quality of Life (via the EQ-5D Questionnaire)	at each follow-up visit	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.

Trial Locations

Locations (57)

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

CH d'AUXERRE; 🇫🇷 Auxerre, France

CH d'AVIGNON; 🇫🇷 Avignon, France

CH de Béziers; 🇫🇷 Beziers, France

CH de Blois; 🇫🇷 Blois, France

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