Clinical trial NCT01108692: Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)
Official title: Investigation on Early Detection and Active Management of Supra-ventricular Arrhythmia With Telecardiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Atrial Flutter
Atrial Tachycardia
Keywords: atrial fibrillation
supraventricular arrhythmia
antithrombotic treatment
antiarrhythmic drugs
medical reaction time
telecardiology
early detection
holters memories
Pacemaker
Lead sponsor: Biotronik France
Sponsor class: INDUSTRY
Collaborators: name: Biotronik SE & Co. KG
First posted: 2010-04-22
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia.
timeFrame: 12-month
Secondary outcomes:
measure: Serious adverse events related to supraventricular arrhythmia.
timeFrame: 12-month
measure: Atrial burden at the end of the study
timeFrame: 12-month
measure: Atrial burden related to time
timeFrame: 12-month
measure: Supraventricular arrhythmia prevalence
timeFrame: 12-month
measure: Number of patients with managed supraventricular arrhythmia
timeFrame: 12-month
measure: Supraventricular arrhythmia symptoms score (via a questionnaire)
timeFrame: at each follow-up visit
measure: Quality of Life (via the EQ-5D Questionnaire)
timeFrame: at each follow-up visit
Other outcomes:
Locations:
city: Abbeville
country: France
facility: CH Général d'Abbeville
city: Aix En Provence
country: France
facility: CH du Pays d'Aix
city: Annecy
country: France
facility: CH de la région d'Annecy
city: Argenteuil
country: France
facility: CH d'Argentueil
city: Arras
country: France
facility: CH d'ARRAS
city: Aurillac
country: France
facility: CH d'AURILLAC
city: Auxerre
country: France
facility: CH d'AUXERRE
city: Avignon
country: France
facility: CH d'AVIGNON
city: Beziers
country: France
facility: CH de Béziers
city: Blois
country: France
facility: CH de Blois
city: Bourges
country: France
facility: Centre Hospitalier Jacques Coeur
city: Bry Sur Marne
country: France
facility: Hôpital Sainte Camille
city: Cannes
country: France
facility: CH de Cannes
city: Castres
country: France
facility: CH de Castres
city: Chalon Sur Saone
country: France
facility: CH William Morey
city: Chartres
country: France
facility: Les Hôpitaux de Chartres
city: Chateauroux
country: France
facility: CH de CHATEAUROUX
city: Cherbourg
country: France
facility: CH Public du Cotentin
city: Clamart
country: France
facility: HIA Percy
city: Colmar
country: France
facility: CHG Louis Pasteur
city: Colmar
country: France
facility: Hôpital Schweitzer
city: Dinan
country: France
facility: CH DINAN
city: Dole
country: France
facility: CH de DOLE
city: Douarnenez
country: France
facility: CH de DOUARNENEZ
city: Evreux
country: France
facility: CHI Eure-Seine
city: Firminy
country: France
facility: CH de Firminy
city: Haguenau
country: France
facility: CH d'HAGUENAU
city: Jonzac
country: France
facility: CH de Jonzac
city: La Rochelle
country: France
facility: CH Saint Louis
city: La-roche-sur-yon
country: France
facility: Centre Hospitalier Départemental Les Oudairies
city: LAGNY sur MARNE
country: France
facility: CH de Lagny
city: Laval
country: France
facility: CH de LAVAL
city: Le Chesnay
country: France
facility: CH A.Mignot
city: Le Mans
country: France
facility: CH du Mans
city: Lens
country: France
facility: CH de Lens
city: Lomme
country: France
facility: Groupe Hospitalier de l'Institut catholique de Lille
city: Longjumeau
country: France
facility: CH de Longjumeau
city: Lorient
country: France
facility: CH Bretagne Sud
city: Metz
country: France
facility: CHR Notre Dame de bon secours
city: Montauban
country: France
facility: CH de MONTAUBAN
city: Montbeliard
country: France
facility: CH de MONTBELIARD
city: MONTCEAU les MINES
country: France
facility: CH Jean Bouveri
city: Montfermeil
country: France
facility: Intercommunal General Hospital LE RAINCY- MONTFERMEIL
city: Orléans
country: France
facility: CHR d'ORLEANS
city: PAU
country: France
facility: CH François Mitterand
city: Roubaix
country: France
facility: CH de Roubaix
city: Saint Jean de Verges
country: France
facility: CHI du Val d'Ariège
city: Saint-brieuc
country: France
facility: CH de SAINT BRIEUC
city: Saint-malo
country: France
facility: CH de SAINT-MALO
city: Saintes
country: France
facility: CH de Saintonge
city: Thionville
country: France
facility: CH Metz-Thionville Bel Air
city: Toulon
country: France
facility: CH de TOULON
city: Troyes
country: France
facility: CH de TROYES
city: Valence
country: France
facility: CH de Valence
city: Valenciennes
country: France
facility: CH de Valenciennes
city: Vannes
country: France
facility: CH Bretagne Atlantique
city: Villeneuve Saint Georges
country: France
facility: CHI de Villeneuve
Study officials:
affiliation: Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE)
name: Walid AMARA, MD
role: PRINCIPAL_INVESTIGATOR
References: