Evolution of the PR Interval in Patients Implanted With a Dual Chamber Pacemaker With Algorithm for Spontaneous AV Conduction Preservation
| Registry | NCT02586480, acronym PRECISE |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 848 (Actual) |
| Sponsor | LivaNova (Industry) |
| Conditions | Sinus Node Dysfunction, Atrioventricular Block |
| Interventions | dual chamber pacemaker with SafeR algorithm (Device) |
| Dates | start 2012-04-01, primary completion 2015-11-01, completion 2015-12-01, first posted 2015-10-26, last updated 2017-10-18 |
| Locations | 58 sites in France |
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Observational study on long PR interval using the SafeR mode in bradycardia patients.
This observational trial aims to study the evolution of the PR interval in patients implanted with a dual chamber pacemaker with the SafeR mode. The investigators will assess the prevalence and the incidence of PR lengthening and the investigators will study the long PR interval management by physicians, depending on the data embedded in the pacemaker.
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Patient implanted (primo-implant, replacement, upgrade) with a Sorin Group™ dual chamber pacemaker according to current available guidelines and IFU from less than three months. * Since implantation, the device is programmed in SafeR mode * Patient agreed to participate, after having received the appropriate and mandatory information Exclusion Criteria: * Patient contraindicated for cardiac pacing, according to current available guidelines * Permanent atrial fibrillation * Permanent high-degree AV block * Patient not available for routine follow-up visits * Patient already included in another clinical study * Inability to understand the purpose of the study / refusal to cooperate * minor age * Pregnancy * Life expectancy less than 12 months * Under guardianship
| Facility | City | Country | Status |
|---|---|---|---|
| CH Basse Terre | Terre Basse, Guadeloupe | France | |
| CH du Pays d'Aix | Aix-en-Provence | France | |
| CH Alençon | Alençon | France | |
| Cabinet Alès | Alès | France | |
| hôpital Sud | Amiens | France | |
| CH Annecy | Annecy | France | |
| hôpital privé Antony | Antony | France | |
| hôpital d'Argenteuil | Argenteuil | France | |
| hôpital St André | Bordeaux | France | |
| CH Bourges | Bourges | France | |
| CHU Brest | Brest | France | |
| Clinique Keraudren | Brest | France | |
| CHU Caen | Caen | France | |
| Clinique des 2 Caps | Calais | France | |
| CH Chartres | Chartres | France | |
| Ch Chaumont | Chaumont | France | |
| Cabinet Cherbourg | Cherbourg | France | |
| HIA Percy | Clamart | France | |
| Hôpital L. Pasteur | Colmar | France | |
| CH Corbeil Essonnes | Corbeil-Essonnes | France | |
| Cabinet Creutzwald | Creutzwald | France | |
| Hopital Henri Mondor | Créteil | France | |
| CH Dinan | Dinan | France | |
| CH Douarnenez | Douarnenez | France | |
| CH Evreux | Évreux | France | |
| CMCO Evry | Évry | France | |
| Cabinet Forbach | Forbach | France | |
| CH Forbach | Forbach | France | |
| CH Haguenau | Haguenau | France | |
| CH Helfaut | Helfaut | France | |
| CH Lannion | Lannion | France | |
| CH Le Havre | Le Havre | France | |
| CMCM Le Mans | Le Mans | France | |
| CMC Port Marly | Le Port-Marly | France | |
| CH Lomme | Lomme | France | |
| CH Lorient | Lorient | France | |
| CHU La Timone | Marseille | France | |
| Hôpital Nord | Marseille | France | |
| Clinique Melun | Melun | France | |
| CH Privé Metz | Metz | France | |
| CH Montfermeil | Montfermeil | France | |
| Clinique Montpellier | Montpellier | France | |
| Clinique A. Paré | Nancy | France | |
| NCN Nantes | Nantes | France | |
| CH Orléans | Orléans | France | |
| Cabinet Paris | Paris | France | |
| CH St Joseph | Paris | France | |
| CH Poissy St Germain | Poissy | France | |
| CHU Poitiers | Poitiers | France | |
| Clinique St Hilaire | Rouen | France | |
| CCN St Denis | Saint-Denis | France | |
| CH St Nazaire | Saint-Nazaire | France | |
| CH Sens | Sens | France | |
| CH St Malo | St-Malo | France | |
| CH Thionville | Thionville | France | |
| CH Valenciennes | Valenciennes | France | |
| Cabinet Valognes | Valognes | France | |
| CH Villefrance | Villefranche-sur-Saône | France |