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

This study has been completed.
Sponsor:
Collaborator:
Biotronik SE & Co. KG
Information provided by (Responsible Party):
Biotronik France
ClinicalTrials.gov Identifier:
NCT01108692
First received: April 21, 2010
Last updated: December 5, 2013
Last verified: December 2013

April 21, 2010
December 5, 2013
July 2010
July 2013   (final data collection date for primary outcome measure)
Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia. [ Time Frame: 12-month ] [ Designated as safety issue: No ]
Delay from enrollment until the next in-office follow-up during which the supraventricular arrhythmia is managed for the first-time.
Same as current
Complete list of historical versions of study NCT01108692 on ClinicalTrials.gov Archive Site
  • Serious adverse events related to supraventricular arrhythmia. [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency
  • Atrial burden at the end of the study [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
  • Atrial burden related to time [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    In order to check if atrial burden is time-dependent.
  • Supraventricular arrhythmia prevalence [ Time Frame: 12-month ] [ Designated as safety issue: No ]
    Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up.
  • Number of patients with managed supraventricular arrhythmia [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    Number of patients with supraventricular arrhythmia and for whom the physician implemented an overall management strategy (antithrombotic and/or antiarrhythmic drugs).
  • Supraventricular arrhythmia symptoms score (via a questionnaire) [ Time Frame: at each follow-up visit ] [ Designated as safety issue: Yes ]
    Questionnaire submitted to the patient at enrollment and at each follow-up visit.
  • Quality of Life (via the EQ-5D Questionnaire) [ Time Frame: at each follow-up visit ] [ Designated as safety issue: Yes ]
    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.
  • Serious adverse events related to supraventricular arrhythmia. [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency
  • Atrial burden at the end of the study [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
  • Atrial burden related to time [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    In order to check if atrial burden is time-dependent.
  • Supraventricular arrhythmia prevalence [ Time Frame: 12-month ] [ Designated as safety issue: No ]
    Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up.
  • Number of patients with managed supraventricular arrhythmia [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    Number of patients with supraventricular arrhythmia and for whom the physician implemented an overall management strategy (antithrombotic and/or antiarrhythmic drugs).
  • Supraventricular arrhythmia symptoms score (via a questionnaire) [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    Questionnaire submitted to the patient at enrollment and at each follow-up visit.
Not Provided
Not Provided
 
Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)
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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Atrial Fibrillation
  • Atrial Flutter
  • Atrial Tachycardia
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.

Other Names:
  • Home-Monitoring
  • Remote monitoring
  • Experimental: Active
    Patients will be followed by telecardiology.
    Intervention: Other: 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.
    Intervention: Other: Telecardiology
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
602
November 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01108692
HS053
Yes
Biotronik France
Biotronik France
Biotronik SE & Co. KG
Principal Investigator: Walid AMARA, MD Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE)
Biotronik France
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP