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

Brief Summary

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

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
  • Study Primary Completion Date: July 2013

Detailed Clinical Trial 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).

Interventions Used in this Clinical Trial

  • Other: Telecardiology
    • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Active
    • Patients will be followed by telecardiology.
  • Active Comparator: Control
    • Patients will be followed in the conventional manner. They will be equipped with telecardiology but data will not be used for patient surveillance.

Outcome Measures for this Clinical Trial

Primary Measures

  • Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia.
    • Time Frame: 12-month
      Safety Issue?: No

Secondary Measures

  • Serious adverse events related to supraventricular arrhythmia.
    • Time Frame: 12-month
      Safety Issue?: Yes
  • Atrial burden at the end of the study
    • Time Frame: 12-month
      Safety Issue?: Yes
  • Atrial burden related to time
    • Time Frame: 12-month
      Safety Issue?: Yes
  • Supraventricular arrhythmia prevalence
    • Time Frame: 12-month
      Safety Issue?: No
  • Number of patients with managed supraventricular arrhythmia
    • Time Frame: 12-month
      Safety Issue?: Yes
  • Supraventricular arrhythmia symptoms score (via a questionnaire)
    • Time Frame: at each follow-up visit
      Safety Issue?: Yes
  • Quality of Life (via the EQ-5D Questionnaire)
    • Time Frame: at each follow-up visit
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Biotronik France
  • Collaborator
    • Biotronik SE & Co. KG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Walid AMARA, MD, Principal Investigator, Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE)

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01108692