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

Biotronik

Status: Completed

Conditions: Atrial Tachycardia; Atrial Flutter; Atrial Fibrillation

Treatments: Other: Telecardiology

Study type: Interventional

Funder types: Industry

Identifiers

NCT01108692

HS053

Details and patient eligibility

About

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.

Full 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).

Enrollment: 602 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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602 participants in 2 patient groups

Active

Experimental group

Description:

Patients will be followed by telecardiology.

Treatment:

Other: Telecardiology

Control

Active Comparator group

Description:

Patients will be followed in the conventional manner. They will be equipped with telecardiology but data will not be used for patient surveillance.

Treatment:

Other: Telecardiology