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

December 5, 2013 updated by: Biotronik France

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

602

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France
        • CH Général d'Abbeville
      • Aix En Provence, France
        • CH du Pays d'Aix
      • Annecy, France
        • CH de la Region d'Annecy
      • Argenteuil, France
        • CH d'Argentueil
      • Arras, France
        • CH d'Arras
      • Aurillac, France
        • CH d'Aurillac
      • Auxerre, France
        • CH d'Auxerre
      • Avignon, France
        • CH d'Avignon
      • Beziers, France
        • CH de Béziers
      • Blois, France
        • CH de Blois
      • Bourges, France, 18016
        • Centre Hospitalier Jacques Coeur
      • Bry Sur Marne, France
        • Hopital Sainte Camille
      • Cannes, France
        • CH de Cannes
      • Castres, France
        • CH de Castres
      • Chalon Sur Saone, France
        • Ch William Morey
      • Chartres, France
        • Les Hôpitaux de Chartres
      • Chateauroux, France
        • CH de Châteauroux
      • Cherbourg, France
        • CH Public du Cotentin
      • Clamart, France
        • HIA Percy
      • Colmar, France
        • CHG Louis Pasteur
      • Colmar, France
        • Hôpital Schweitzer
      • Dinan, France
        • CH DINAN
      • Dole, France
        • CH de DOLE
      • Douarnenez, France
        • CH de Douarnenez
      • Evreux, France
        • CHI Eure-Seine
      • Firminy, France
        • CH de Firminy
      • Haguenau, France
        • CH d'Haguenau
      • Jonzac, France
        • CH de Jonzac
      • LAGNY sur MARNE, France
        • CH de Lagny
      • La Rochelle, France
        • CH Saint Louis
      • La-roche-sur-yon, France, 85925
        • Centre Hospitalier Departemental Les Oudairies
      • Laval, France
        • CH de Laval
      • Le Chesnay, France
        • CH A.Mignot
      • Le Mans, France
        • CH du Mans
      • Lens, France
        • CH de Lens
      • Lomme, France
        • Groupe Hospitalier de l'Institut Catholique de Lille
      • Longjumeau, France
        • CH de Longjumeau
      • Lorient, France
        • CH Bretagne Sud
      • MONTCEAU les MINES, France
        • CH Jean Bouveri
      • Metz, France
        • CHR Notre Dame de bon secours
      • Montauban, France
        • CH de Montauban
      • Montbeliard, France
        • CH de MONTBELIARD
      • Montfermeil, France, 93370
        • Intercommunal General Hospital LE RAINCY- MONTFERMEIL
      • Orléans, France
        • CHR d'ORLEANS
      • PAU, France
        • CH Francois Mitterand
      • Roubaix, France
        • CH de Roubaix
      • Saint Jean de Verges, France
        • CHI du Val d'Ariège
      • Saint-brieuc, France
        • CH de Saint Brieuc
      • Saint-malo, France
        • CH de Saint-Malo
      • Saintes, France
        • CH de Saintonge
      • Thionville, France
        • CH Metz-Thionville Bel Air
      • Toulon, France
        • CH de Toulon
      • Troyes, France
        • CH de Troyes
      • Valence, France
        • CH de Valence
      • Valenciennes, France
        • CH de Valenciennes
      • Vannes, France
        • CH Bretagne Atlantique
      • Villeneuve Saint Georges, France
        • CHI de Villeneuve

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Patients will be followed by telecardiology.
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:
  • Remote monitoring
  • Home-Monitoring
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.
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:
  • Remote monitoring
  • Home-Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious adverse events related to supraventricular arrhythmia.
Time Frame: 12-month
Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency
12-month
Atrial burden at the end of the study
Time Frame: 12-month
12-month
Atrial burden related to time
Time Frame: 12-month
In order to check if atrial burden is time-dependent.
12-month
Supraventricular arrhythmia prevalence
Time Frame: 12-month
Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up.
12-month
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).
12-month
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.
at each follow-up visit
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.
at each follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik France

Collaborators

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Walid AMARA, MD, Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 21, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 6, 2013

Last Update Submitted That Met QC Criteria

December 5, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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