Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)
NCT ID: NCT01108692
Last Updated: 2013-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
602 participants
INTERVENTIONAL
2010-07-31
2013-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active
Patients will be followed by telecardiology.
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.
Control
Patients will be followed in the conventional manner. They will be equipped with telecardiology but data will not be used for patient surveillance.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biotronik SE & Co. KG
INDUSTRY
Biotronik France
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Walid AMARA, MD
Role: PRINCIPAL_INVESTIGATOR
Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Béziers, , 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-Saône, , France
Les Hôpitaux de Chartres
Chartres, , France
CH de CHATEAUROUX
Châteauroux, , 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
Évreux, , France
CH de Firminy
Firminy, , France
CH d'HAGUENAU
Haguenau, , France
CH de Jonzac
Jonzac, , France
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, , France
CH Saint Louis
La Rochelle, , 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
Montbéliard, , 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
CH de SAINT BRIEUC
Saint-Brieuc, , France
CHI du Val d'Ariège
Saint-Jean-de-Verges, , France
CH de Saintonge
Saintes, , France
CH de SAINT-MALO
St-Malo, , 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HS053
Identifier Type: -
Identifier Source: org_study_id