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| ID | Type | Description | Link |
|---|---|---|---|
| IBSY02 |
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The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.
The expected benefits will be a result of the reduction of the percentage of ventricular pacing.
It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation.
The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AAIsafeR /SafeR Patient randomized with the SafeR switched ON |
|
| 2 | Experimental | DDD(R) mode. Patients randomized with the SafeR mode switched OFF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symphony DR 2550 and REPLY DR cardiac pacemakers | Device | AAISafeR/SafeR ON |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure) | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of paroxysmal AV blocks | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stockburger Martin, MD | Head of Pacemaker/Defibrillator/CRT department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 736 Cambridge Street | Brighton | Massachusetts | MA 02135 | United States | ||
| CHU - Hopital Sud |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 14, 2015 | |
| Reset | May 4, 2015 | |
| Release | Nov 10, 2017 |
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| Symphony DR 2550 and REPLY DR cardiac pacemakers |
| Device |
DDD(R) (SafeR OFF) |
|
| Amiens |
| 80054 |
| France |
| Centre hospitalier de Béthune | Béthune | 62408 | France |
| CHU - Hopital Michallon | Grenoble | 38043 | France |
| CHP Beauregard | Marseille | 13012 | France |
| CHU A de Villeneuve | Montpellier | 34295 | France |
| Clinique Bizet | Paris | 75116 | France |
| CHU Hopital C. Nicolle | Rouen | 76035 | France |
| CCN | Saint-Denis | 93207 | France |
| CHU - Hopital Nord | Saint-Etienne | 42055 | France |
| CHU Hautepierre | Strasbourg | 67098 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| CHU Hopital Trousseau | Tours | 37044 | France |
| CHU de Nancy | Vandœuvre-lès-Nancy | 54511 | France |
| Charite Virchow | Berlin | Germany |
| Bernau hospital | Bernau | Germany |
| Braunschweig hospital | Braunschweig | 38100 | Germany |
| Elisabeth KH Essen | Essen | D-45138 | Germany |
| Leipzig Uni | Leipzig | 04103 | Germany |
| Lübeck Uni | Lübeck | D-23538 | Germany |
| Lüdenscheid hospital | Lüdenscheid | 58515 | Germany |
| Mainz Uni | Mainz | 55101 | Germany |
| München Innenstadt | München | 80336 | Germany |
| Remscheid hospital | Remscheid | 42859 | Germany |
| Ulm Uni | Ulm | 89081 | Germany |
| Clinica Villa Pini d'Abruzzo | Chieti | 66100 | Italy |
| Osp Civile di Montebelluna | Conegliano | 31015 | Italy |
| Ospedale Umberto I | Mestre | 30173 | Italy |
| Presidio Ospedaliero di Mirano | Mirano | 30035 | Italy |
| Azienda Ospedaliera S. Maria | Terni | 05100 | Italy |
| Complejo Hospitalario Arquitecto Marcide | Ferrol | 15405 | Spain |
| Hospital Universitario de Madrid | Madrid | 28041 | Spain |
| Hospital Montecelo | Mourente | 36071 | Spain |
| Povisa | Salamanca | Spain |
| Hospital Clinico universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Complejo Hospitalario Xeral-Cies | Vigo | 3204 | Spain |
| William Harvey Hospital | Ashford | Kent TN24 OLZ | United Kingdom |
| Reset | Dec 11, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 14, 2015 | May 4, 2015 | |||
| Nov 10, 2017 | Dec 11, 2017 |