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

Atrial Fibrillation Clinical Trial

— SETAM  

Official title:

Investigation on Early Detection and Active Management of Supra-ventricular Arrhythmia With Telecardiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108692
• Other study ID #: HS053
• Status: Completed
• Phase: N/A
• First received: April 21, 2010
• Last updated: December 5, 2013
• Start date: July 2010
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Biotronik France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: November 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Atrial Tachycardia
• Tachycardia

Intervention

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.

Locations

Country	Name	City	State
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	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	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	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

Sponsors (2)

Lead Sponsor	Collaborator
Biotronik France	Biotronik SE & Co. KG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia.	Delay from enrollment until the next in-office follow-up during which the supraventricular arrhythmia is managed for the first-time.	12-month	No
Secondary	Serious adverse events related to supraventricular arrhythmia.	Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency	12-month	Yes
Secondary	Atrial burden at the end of the study		12-month	Yes
Secondary	Atrial burden related to time	In order to check if atrial burden is time-dependent.	12-month	Yes
Secondary	Supraventricular arrhythmia prevalence	Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up.	12-month	No
Secondary	Number of patients with managed supraventricular arrhythmia	Number of patients with supraventricular arrhythmia and for whom the physician implemented an overall management strategy (antithrombotic and/or antiarrhythmic drugs).	12-month	Yes
Secondary	Supraventricular arrhythmia symptoms score (via a questionnaire)	Questionnaire submitted to the patient at enrollment and at each follow-up visit.	at each follow-up visit	Yes
Secondary	Quality of Life (via the EQ-5D Questionnaire)	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	Yes