Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm, sensing and capture, and thus to detect anomalies that may deserve a clinical action.
PREMS is a non-interventional, prospective, and multicenter study. The primary objective is to assess the added clinical value of periodic IEGMs, based on the rate of patients with a rhythm or sensing/pacing anomaly detected on the first IEGM transmitted by Home Monitoring (HM) and non detectable so obvious on the other parameter set offered for the remote follow-up.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pacemaker recipients | Patients implanted with a single or dual pacemaker and with Home-Monitoring system activated and periodic IEGM activated |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Added clinical value of periodic IEGM | The main objective of the study is to evaluate the added clinical value of periodic IEGMs for the remote follow-up of PM, compared to other HM data offered by the remote follow-up. Primary endpoint: Rate of patients with at least one rhythm or sensing/pacing anomaly detected on the periodic IEGM, and non detectable on the other HM data. The anomalies are defined as an arrhythmia (extrasystole, atrial fibrillation or flutter), loss of sensing, oversensing or loss of capture. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Planned corrective action | Rate of detected anomalies triggering a planned corrective action | 1 month |
| Added clinical value of the remote follow-up | Rate of anomalies that can be identified based on remote data other than the periodic IEGM and comparison with the previous event notifications |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patient implanted with a single or dual chamber pacemaker and with the Biotronik Home-Monitoring® system activated
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Arnaud Lazarus, MD | Clinique Ambroise Paré, Neuilly sur Seine, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Axium | Aix-en-Provence | France | ||||
| Clinique de l'Anjou |
Not provided
Not provided
Not provided
Not provided
| 1 month |
| Type of detected anomalies | The types of anomalies detected on the periodic IEGM or/and on the other HM data will be evaluated separately (arrhythmia, loss of capture, loss of sensing, oversensing) | 1 month |
| Capability of periodic IEGM to fulfil the guidelines requirements | The periodic IEGMs transmitted by HM are designed in accordance with ACC/AHA/HRS guidelines. Indeed, guidelines for a PM follow-up require to determine the current intrinsic rhythm, but also to check the appropriate sensing and capture. The periodic IEGM could remotely provide the same information than an in-office follow-up. So, the capability of periodic IEGM to fulfil the requirements for PM follow-up by ACC/AHA/HRS guidelines will be evaluated. | 1 month |
| Angers |
| 49044 |
| France |
| CH d'Annecy | Annecy | France |
| CH Annonay | Annonay | France |
| CH d'Antibes | Antibes | 06606 | France |
| CH d'Aurillac | Aurillac | France |
| CH de Bastia | Bastia | France |
| Clinique Saint Vincent | Besançon | France |
| CH de Blois | Blois | France |
| Cabinet de Cardiologie | Bordeaux | France |
| Polyclinique Nord Aquitaine | Bordeaux | France |
| CH Pierre Oudot | Bourgoin | France |
| CH des Broussailles | Cannes | France |
| CH de Castres | Castres | France |
| Polyclinique Sevigné | Cesson-Sévigné | France |
| CH de Chambéry | Chambéry | France |
| Hôpital Privé Paul d'Egine | Champigny-sur-Marne | France |
| CH de Chartres | Chartres | France |
| Clinique Bon Secours | Châtellerault | France |
| Polyclinique du Parc | Cholet | France |
| Clinique des Dômes | Clermont-Ferrand | France |
| CH de Douarnenez | Douarnenez | France |
| Clinique du Mousseau | Évry | France |
| Clinique de la Marche | Guéret | France |
| Cabinet de cardiologie | Le Puy-en-Velay | France |
| CHG de Longjumeau | Longjumeau | France |
| CH St Luc St Joseph | Lyon | France |
| Clinique Clairval | Marseille | France |
| CH Montbrison | Montbrison | France |
| CH de Nevers | Nevers | France |
| Cabinet Descartes | Niort | France |
| CH de Niort | Niort | France |
| CH Léon Binet | Provins | France |
| Polyclinique Saint Laurent | Rennes | France |
| CH de Roanne | Roanne | France |
| CHU Hôpital Charles Nicolle | Rouen | France |
| CH Val d'Ariège | Saint Jean de Verge | France |
| Clinique de Saint Georges de Didonnes | Saint-Georges-de-Didonne | France |
| Clinique Belledonne | Saint-Martin-d'Hères | France |
| CH de Saint Malo | St-Malo | France |
| Hôpitaux du Léman | Thonon-les-Bains | France |
| HIA Saint Anne | Toulon | France |
| Hôpital Sainte Musse CHI | Toulon | France |
| HPOP | Trappes | France |
| CH de Valence | Valence | France |
| Cabinet de cardiologie | Valognes | France |
| CH André Mignot | Versailles | France |
| CH Paul Morel | Vesoul | France |
| CHG Villefranche | Villefranche-sur-Saône | France |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided