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| Name | Class |
|---|---|
| Biotronik SE & Co. KG | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Patients will be followed by telecardiology. |
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| Control | Active Comparator | Patients will be followed in the conventional manner. They will be equipped with telecardiology but data will not be used for patient surveillance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telecardiology | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events related to supraventricular arrhythmia. | Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency | 12-month |
| Atrial burden at the end of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walid AMARA, MD | Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Général d'Abbeville | Abbeville | France | ||||
| CH du Pays d'Aix |
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|
|
| 12-month |
| Atrial burden related to time | In order to check if atrial burden is time-dependent. | 12-month |
| Supraventricular arrhythmia prevalence | Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up. | 12-month |
| 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 |
| 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 |
| 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 |
| 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 | 18016 | 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 | 85925 | 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 | 93370 | 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 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015190 | Blood Glucose Self-Monitoring |
| D000098465 | Remote Patient Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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