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| ID | Type | Description | Link |
|---|---|---|---|
| IPRE03 |
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This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.
In this study, patients are randomized to DDD mode, AAIsafeR mode, or AAIsafeR mode plus atrial arrhythmia preventive algorithms. The atrial arrhythmia (AA) burden serves as the primary measure of effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PACEMAKER SYMPHONY 2550 | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atrial arrhythmia burden |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Banner Baywood Heart Hospital |
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| Mesa |
| Arizona |
| 85206 |
| United States |
| Brentwood Biomedical Research Institute | Los Angeles | California | 90073 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Passaic Beth Israel Regional Medical Center | Passaic | New Jersey | 07055 | United States |
| NorthEast Medical Center | Concord | North Carolina | 28025 | United States |
| Hillcrest Medical Center | Tulsa | Oklahoma | 74104 | United States |
| Lancaster Regional Medical Center | Lancaster | Pennsylvania | 17603 | United States |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | United States |
| OLV Aalst | Aalst | 9300 | Belgium |
| Cliniques Sud Luxembourg | Arlon | 6700 | Belgium |
| Clinique Saint-Jean | Brussels | 1000 | Belgium |
| Algemeen Ziekenhuis Sint-Dimpna | Geel | 2440 | Belgium |
| Centre Hospitalier Hutois | Huy | 4500 | Belgium |
| CHU Tivoli | La Louvière | 7100 | Belgium |
| Algemeen Ziekenhuis Sint-Augustinus | Wilrijk | 2610 | Belgium |
| UCL Mont-Godinne | Yvoir | 5530 | Belgium |
| CHG d'Albi | Albi | 81013 | France |
| CHRU du Morvan Hôpital la Cavale Blanche | Brest | 29069 | France |
| Hospice St-Jacques-Hôpital G.Montpied | Clermond-Ferrand | 63003 | France |
| Hôpital Henri Mondor | Créteil | 94010 | France |
| C.H.I. du Val d'Ariège | Foix | 09017 | France |
| CHRU de Grenoble Hôpital Michallon | Grenoble | 38043 | France |
| Polyclinique du Bois | Lille | 59003 | France |
| CHU de Limoges Hôpital Dupuytren | Limoges | 87042 | France |
| Clinique Clairval | Marseille | 13009 | France |
| Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France |
| Polyclinique de Gentilly | Nancy | 54100 | France |
| Nouvelles Cliniques Nantaises | Nantes | 44277 | France |
| Hôpital Pasteur | Nice | 6000 | France |
| Hôpital Pitié-Salpêtrière | Paris | 75013 | France |
| InParys CLINIQUE BIZET | Paris | 75016 | France |
| CHU Haut l'Evêque | Pessac | 33604 | France |
| CHU Pontchaillou | Rennes | 35033 | France |
| CHU - Hôpital Charles Nicolle | Rouen | 76031 | France |
| Centre Cardiologique du Nord | Saint-Denis | 93200 | France |
| Centre Hospitalier Rangueil | Toulouse | 31403 | France |
| CHU Brabois | Vandœuvre-lès-Nancy | 54500 | France |
| Hufeland Krankenhaus GmbH | Bad Langensalza | 99947 | Germany |
| Charite Campus Virchow | Berlin | 13353 | Germany |
| Kliniken der Stadt Köln | Cologne | D-51067 | Germany |
| Universitätklinikum Leipzig | Leipzig | D-04103 | Germany |
| Universitätklinik. Lübeck | Lübeck | 23538 | Germany |
| Klinikum Lüdenscheid | Lüdenscheid | D-58515 | Germany |
| Johannes Gutenberg-Universität - Mainz Klinikum | Mainz | D-55101 | Germany |
| Klinikum Memmingen | Memmingen | 87700 | Germany |
| Ospedale San Tommaso dei Battuti | Portogruaro | VE | 30026 | Italy |
| CH Princesse Grace | Monaco | 98012 | Monaco |
| Complejo Hospitalario Universitario de Vigo (CHUVI) | Pontevedra | 36204 | Spain |
| Eastbourne District General Hospital | Eastbourne | East Sussex | BN21 2UD | United Kingdom |
| St Peters Hospital | Chertsey | Surrey | KT16 0PZ | United Kingdom |
| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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