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Completed

NCT Number: NCT01108692

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Atrial Tachycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Général d'Abbeville, Abbeville, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telecardiology

Other

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.

Other names: Home-Monitoring, Remote monitoring

Primary outcomes

  1. Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia.

    Time frame: 12-month

    Delay from enrollment until the next in-office follow-up during which the supraventricular arrhythmia is managed for the first-time.

Secondary outcomes

  1. Serious adverse events related to supraventricular arrhythmia.

    Time frame: 12-month

    Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency

  2. Atrial burden at the end of the study

    Time frame: 12-month

  3. Atrial burden related to time

    Time frame: 12-month

    In order to check if atrial burden is time-dependent.

  4. Supraventricular arrhythmia prevalence

    Time frame: 12-month

    Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up.

  5. Number of patients with managed supraventricular arrhythmia

    Time frame: 12-month

    Number of patients with supraventricular arrhythmia and for whom the physician implemented an overall management strategy (antithrombotic and/or antiarrhythmic drugs).

  6. Supraventricular arrhythmia symptoms score (via a questionnaire)

    Time frame: at each follow-up visit

    Questionnaire submitted to the patient at enrollment and at each follow-up visit.

  7. Quality of Life (via the EQ-5D Questionnaire)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Biotronik France

Industry

Collaborators

  • Biotronik SE & Co. KG

Registry information

Official study title

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

Acronym: SETAM

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 22, 2010
Registry last updated
Dec 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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