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
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Atrial Flutter
Atrial Tachycardia
Other: Telecardiology

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Investigation on Early Detection and Active Management of Supra-ventricular Arrhythmia With Telecardiology

Resource links provided by NLM:


Further study details as provided by Biotronik France:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 602
Study Start Date: July 2010
Study Completion Date: November 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Home-Monitoring
  • Remote 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:
  • Home-Monitoring
  • Remote monitoring

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108692

  Hide Study Locations
Locations
France
CH Général d'Abbeville
Abbeville, France
CH du Pays d'Aix
Aix En Provence, France
CH de la région d'Annecy
Annecy, France
CH d'Argentueil
Argenteuil, France
CH d'ARRAS
Arras, France
CH d'AURILLAC
Aurillac, France
CH d'AUXERRE
Auxerre, France
CH d'AVIGNON
Avignon, France
CH de Béziers
Beziers, France
CH de Blois
Blois, France
Centre Hospitalier Jacques Coeur
Bourges, France, 18016
Hôpital Sainte Camille
Bry Sur Marne, France
CH de Cannes
Cannes, France
CH de Castres
Castres, France
CH William Morey
Chalon Sur Saone, France
Les Hôpitaux de Chartres
Chartres, France
CH de CHATEAUROUX
Chateauroux, France
CH Public du Cotentin
Cherbourg, France
HIA Percy
Clamart, France
CHG Louis Pasteur
Colmar, France
Hôpital Schweitzer
Colmar, France
CH DINAN
Dinan, France
CH de DOLE
Dole, France
CH de DOUARNENEZ
Douarnenez, France
CHI Eure-Seine
Evreux, France
CH de Firminy
Firminy, France
CH d'HAGUENAU
Haguenau, France
CH de Jonzac
Jonzac, France
CH Saint Louis
La Rochelle, France
Centre Hospitalier Départemental Les Oudairies
La-roche-sur-yon, France, 85925
CH de Lagny
LAGNY sur MARNE, France
CH de LAVAL
Laval, France
CH A.Mignot
Le Chesnay, France
CH du Mans
Le Mans, France
CH de Lens
Lens, France
Groupe Hospitalier de l'Institut catholique de Lille
Lomme, France
CH de Longjumeau
Longjumeau, France
CH Bretagne Sud
Lorient, France
CHR Notre Dame de bon secours
Metz, France
CH de MONTAUBAN
Montauban, France
CH de MONTBELIARD
Montbeliard, France
CH Jean Bouveri
MONTCEAU les MINES, France
Intercommunal General Hospital LE RAINCY- MONTFERMEIL
Montfermeil, France, 93370
CHR d'ORLEANS
Orléans, France
CH François Mitterand
PAU, France
CH de Roubaix
Roubaix, France
CHI du Val d'Ariège
Saint Jean de Verges, France
CH de SAINT BRIEUC
Saint-brieuc, France
CH de SAINT-MALO
Saint-malo, France
CH de Saintonge
Saintes, France
CH Metz-Thionville Bel Air
Thionville, France
CH de TOULON
Toulon, France
CH de TROYES
Troyes, France
CH de Valence
Valence, France
CH de Valenciennes
Valenciennes, France
CH Bretagne Atlantique
Vannes, France
CHI de Villeneuve
Villeneuve Saint Georges, France
Sponsors and Collaborators
Biotronik France
Biotronik SE & Co. KG
Investigators
Principal Investigator: Walid AMARA, MD Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE)
  More Information

No publications provided

Responsible Party: Biotronik France
ClinicalTrials.gov Identifier: NCT01108692     History of Changes
Other Study ID Numbers: HS053
Study First Received: April 21, 2010
Last Updated: December 5, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Keywords provided by Biotronik France:
atrial fibrillation
supraventricular arrhythmia
antithrombotic treatment
antiarrhythmic drugs
medical reaction time
telecardiology
early detection
holters memories
Pacemaker
Telecardiology

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Atrial Flutter
Tachycardia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014