Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)
- Conditions
- Atrial FlutterAtrial FibrillationAtrial Tachycardia
- Interventions
- Other: Telecardiology
- Registration Number
- NCT01108692
- Lead Sponsor
- Biotronik France
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 602
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Telecardiology Patients will be followed by telecardiology. Control Telecardiology Patients will be followed in the conventional manner. They will be equipped with telecardiology but data will not be used for patient surveillance.
- Primary Outcome Measures
Name Time Method Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia. 12-month Delay from enrollment until the next in-office follow-up during which the supraventricular arrhythmia is managed for the first-time.
- Secondary Outcome Measures
Name Time Method Atrial burden at the end of the study 12-month Number of patients with managed supraventricular arrhythmia 12-month Number of patients with supraventricular arrhythmia and for whom the physician implemented an overall management strategy (antithrombotic and/or antiarrhythmic drugs).
Serious adverse events related to supraventricular arrhythmia. 12-month Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency
Atrial burden related to time 12-month In order to check if atrial burden is time-dependent.
Supraventricular arrhythmia prevalence 12-month Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up.
Supraventricular arrhythmia symptoms score (via a questionnaire) at each follow-up visit Questionnaire submitted to the patient at enrollment and at each follow-up visit.
Quality of Life (via the EQ-5D Questionnaire) 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.
Trial Locations
- Locations (57)
Hôpital Sainte Camille
🇫🇷Bry Sur Marne, France
CH William Morey
🇫🇷Chalon Sur Saone, France
CH de DOLE
🇫🇷Dole, France
CH de DOUARNENEZ
🇫🇷Douarnenez, France
CH de Firminy
🇫🇷Firminy, France
CH d'HAGUENAU
🇫🇷Haguenau, France
CH A.Mignot
🇫🇷Le Chesnay, France
CH Bretagne Sud
🇫🇷Lorient, France
CHR d'ORLEANS
🇫🇷Orléans, France
CH de MONTBELIARD
🇫🇷Montbeliard, France
Centre Hospitalier Jacques Coeur
🇫🇷Bourges, France
CH de la région d'Annecy
🇫🇷Annecy, France
CH de Cannes
🇫🇷Cannes, France
CH de Castres
🇫🇷Castres, France
CH d'Argentueil
🇫🇷Argenteuil, France
CH d'AVIGNON
🇫🇷Avignon, France
Les Hôpitaux de Chartres
🇫🇷Chartres, France
HIA Percy
🇫🇷Clamart, France
CH Général d'Abbeville
🇫🇷Abbeville, France
CH du Pays d'Aix
🇫🇷Aix En Provence, France
CH d'ARRAS
🇫🇷Arras, France
CH de Béziers
🇫🇷Beziers, France
CH d'AURILLAC
🇫🇷Aurillac, France
CH d'AUXERRE
🇫🇷Auxerre, France
CH de Blois
🇫🇷Blois, France
CH de CHATEAUROUX
🇫🇷Chateauroux, France
CHG Louis Pasteur
🇫🇷Colmar, France
Hôpital Schweitzer
🇫🇷Colmar, France
CH DINAN
🇫🇷Dinan, France
CHI Eure-Seine
🇫🇷Evreux, France
CH de Jonzac
🇫🇷Jonzac, France
CH de Lagny
🇫🇷LAGNY sur MARNE, France
CH de LAVAL
🇫🇷Laval, France
CH de Lens
🇫🇷Lens, France
Groupe Hospitalier de l'Institut catholique de Lille
🇫🇷Lomme, France
CH de Longjumeau
🇫🇷Longjumeau, France
CH Saint Louis
🇫🇷La Rochelle, France
Centre Hospitalier Départemental Les Oudairies
🇫🇷La-roche-sur-yon, France
CH du Mans
🇫🇷Le Mans, France
CH de MONTAUBAN
🇫🇷Montauban, France
Intercommunal General Hospital LE RAINCY- MONTFERMEIL
🇫🇷Montfermeil, France
CH François Mitterand
🇫🇷PAU, France
CHR Notre Dame de bon secours
🇫🇷Metz, France
CH Jean Bouveri
🇫🇷MONTCEAU les MINES, France
CH de Roubaix
🇫🇷Roubaix, France
CH de TOULON
🇫🇷Toulon, France
CH de TROYES
🇫🇷Troyes, France
CH de Saintonge
🇫🇷Saintes, France
CH Metz-Thionville Bel Air
🇫🇷Thionville, France
CH Public du Cotentin
🇫🇷Cherbourg, France
CHI de Villeneuve
🇫🇷Villeneuve Saint Georges, 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 Bretagne Atlantique
🇫🇷Vannes, France
CH de Valence
🇫🇷Valence, France
CH de Valenciennes
🇫🇷Valenciennes, France