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| Sponsor: | Biotronik France |
|---|---|
| Collaborator: |
Biotronik SE & Co. KG |
| Information provided by: | Biotronik France |
| ClinicalTrials.gov Identifier: | NCT01108692 |
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 :
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 |
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (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:
|
|
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:
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Amandine WOUTERS, ENG | +33 (1) 46 75 96 60 | amandine.wouters@biotronik.fr |
| Contact: Nicolas CANOT, ENG | +33 (1) 46 75 96 60 | nicolas.canot@biotronik.fr |
| France | |
| CH Général d'Abbeville | Recruiting |
| Abbeville, France | |
| Principal Investigator: Nouredine EL HAJJAJI, MD | |
| CH du Pays d'Aix | Recruiting |
| Aix En Provence, France | |
| Principal Investigator: Claude BARNAY, MD | |
| CH de la région d'Annecy | Recruiting |
| Annecy, France | |
| Principal Investigator: Antoine DOMPNIER, MD | |
| CH d'Argentueil | Recruiting |
| Argenteuil, France | |
| Contact: Dr GOUDGJIL | |
| Principal Investigator: Mohand Dr GOUDGIL | |
| CH d'ARRAS | Recruiting |
| Arras, France | |
| Contact: Etienne BEAREZ, MD | |
| Principal Investigator: Etienne BEAREZ, MD | |
| CH d'AURILLAC | Recruiting |
| Aurillac, France | |
| Contact: Manuel FONT, Dr | |
| Principal Investigator: Manuel MD FONT | |
| CH d'AUXERRE | Recruiting |
| Auxerre, France | |
| Principal Investigator: François-Xavier SOTO, MD | |
| CH d'AVIGNON | Recruiting |
| Avignon, France | |
| Contact: CHEGGOUR, Dr | |
| Principal Investigator: Saida CHEGGOUR, Dr | |
| Centre Hospitalier Jacques Coeur | Recruiting |
| Bourges, France, 18016 | |
| Contact: Isabelle HEURTEBISE, MD +33 2 48 48 49 16 isabelle.labioche@ch-bourges.fr | |
| Principal Investigator: Isabelle HEURTEBISE, MD | |
| Hôpital Sainte Camille | Recruiting |
| Bry Sur Marne, France | |
| Principal Investigator: Aimé BONNY, MD | |
| CH de Cannes | Recruiting |
| Cannes, France | |
| Contact: Thierry TIBI, MD | |
| Principal Investigator: Thierry TIBI, MD | |
| CH de Castres | Recruiting |
| Castres, France | |
| Principal Investigator: Pascal CHAVERNAC, MD | |
| CH William Morey | Recruiting |
| Chalon Sur Saone, France | |
| Contact: Pascal SAGNOL, MD | |
| Principal Investigator: Pascal SAGNOL, MD | |
| Les Hôpitaux de Chartres | Recruiting |
| Chartres, France | |
| Principal Investigator: Hervé GORKA, MD | |
| CH de CHATEAUROUX | Recruiting |
| Chateauroux, France | |
| Contact: POITRINEAU, Dr | |
| Principal Investigator: POITRINEAU, Dr | |
| CH Public du Cotentin | Recruiting |
| Cherbourg, France | |
| Contact: Didier BINET, MD | |
| Principal Investigator: Didier BINET, MD | |
| HIA Percy | Recruiting |
| Clamart, France | |
| Contact: HENO, Pr | |
| Principal Investigator: Philippe HENO, Pr | |
| Sub-Investigator: Jules LOUEMBE, Dr | |
| Hôpital Schweitzer | Recruiting |
| Colmar, France | |
| Contact: BELLMONT, Dr | |
| Principal Investigator: Sandrine BELLMONT, Dr | |
| CHG Louis Pasteur | Recruiting |
| Colmar, France | |
| Contact: AHRES, Dr | |
| Principal Investigator: Said AHRES, Dr | |
| CH DINAN | Recruiting |
| Dinan, France | |
| Contact: BAZIN, Dr | |
| Principal Investigator: Patrick BAZIN, Dr | |
| CH de DOUARNENEZ | Recruiting |
| Douarnenez, France | |
| Contact: Jean-Philippe EL KAIM, MD | |
| Principal Investigator: Jean-Philippe EL KAIM, MD | |
| CHI Eure-Seine | Recruiting |
| Evreux, France | |
| Contact: Nacera RABAH, MD | |
| Principal Investigator: Nacera RABAH, MD | |
| CH de Firminy | Recruiting |
| Firminy, France | |
| Principal Investigator: Loucif ABDELLAOUI | |
| CH d'HAGUENAU | Recruiting |
| Haguenau, France | |
| Principal Investigator: Sébastien BUFFLER, MD | |
| Centre Hospitalier Départemental Les Oudairies | Recruiting |
| La-roche-sur-yon, France, 85925 | |
| Contact: Claude GULLY, MD +33 2 51 44 61 61 claude.gully@chd-vendee.fr | |
| Principal Investigator: Claude GULLY, MD | |
| CH de LAVAL | Recruiting |
| Laval, France | |
| Contact: BIENVENU, Dr | |
| Principal Investigator: BIENVENU, Dr | |
| CH du Mans | Recruiting |
| Le Mans, France | |
| Principal Investigator: Samuel BROUDIN, MD | |
| CH Bretagne Sud | Recruiting |
| Lorient, France | |
| Contact: Pierre KHATTAR, MD | |
| Principal Investigator: Pierre KHATTAR, MD | |
| CHR Notre Dame de bon secours | Recruiting |
| Metz, France | |
| Contact: Michel BOURSIER, MD | |
| Principal Investigator: Michel BOURSIER, MD | |
| CH de MONTAUBAN | Recruiting |
| Montauban, France | |
| Contact: SOMODY, Dr | |
| Principal Investigator: Elisabeth SOMODY, Dr | |
| CH de MONTBELIARD | Recruiting |
| Montbeliard, France | |
| Contact: FOUCHE, Dr | |
| Principal Investigator: Renaud FOUCHE, Dr | |
| Intercommunal General Hospital LE RAINCY- MONTFERMEIL | Recruiting |
| Montfermeil, France, 93370 | |
| Contact: Walid AMARA, MD +33 1 41 70 80 00 wamara@ch-montfermeil.fr | |
| Principal Investigator: Walid AMARA, MD | |
| CH de Narbonne | Recruiting |
| Narbonne, France | |
| Principal Investigator: Frédéric GEORGER, MD | |
| CHR d'ORLEANS | Recruiting |
| Orléans, France | |
| Principal Investigator: Olivier BIZEAU, MD | |
| CH de Roubaix | Recruiting |
| Roubaix, France | |
| Principal Investigator: Hélène CORDOVA, MD | |
| CHI du Val d'Ariège | Recruiting |
| Saint Jean de Verges, France | |
| Principal Investigator: Gilles BRIERRE, MD | |
| CH de SAINT BRIEUC | Recruiting |
| Saint-brieuc, France | |
| Contact: BEAUVERGER, Dr | |
| Principal Investigator: BEAUVERGER, Dr | |
| CH de SAINT-MALO | Recruiting |
| Saint-malo, France | |
| Contact: DEUTSCH, Dr | |
| Principal Investigator: Philippe DEUTSCH, Dr | |
| CH de Saintonge | Recruiting |
| Saintes, France | |
| Principal Investigator: Nicolas LEJEUNE, MD | |
| CH de TOULON | Recruiting |
| Toulon, France | |
| Contact: LAKHAL, Dr | |
| Principal Investigator: Essia LAKHAL, Dr | |
| Sub-Investigator: Isabelle LECARDONNEL, Dr | |
| CH de TROYES | Recruiting |
| Troyes, France | |
| Contact: MAILLIER, Dr | |
| Principal Investigator: Bruno MAILLIER, Dr | |
| CH de Valenciennes | Recruiting |
| Valenciennes, France | |
| Principal Investigator: André PHILIAS, MD | |
| CH Bretagne Atlantique | Recruiting |
| Vannes, France | |
| Contact: Christian MONTAGNIER, MD | |
| Principal Investigator: Christian MONTAGNIER, MD | |
| CHI de Villeneuve | Recruiting |
| Villeneuve Saint Georges, France | |
| Contact: Olivier GARTENLAUB, MD | |
| Principal Investigator: Olivier GARTENLAUB, MD | |
| Principal Investigator: | Walid AMARA, MD | Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE) |
More Information
| Responsible Party: | Nicolas Canot/Clinical Research Director, Biotronik France |
| ClinicalTrials.gov Identifier: | NCT01108692 History of Changes |
| Other Study ID Numbers: | HS053 |
| Study First Received: | April 21, 2010 |
| Last Updated: | July 19, 2011 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency France: Institutional Ethical Committee |
|
atrial fibrillation supraventricular arrhythmia antithrombotic treatment antiarrhythmic drugs medical reaction time |
telecardiology early detection holters memories Pacemaker Telecardiology |
|
Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Tachycardia Heart Diseases Cardiovascular Diseases |
Pathologic Processes Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
