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| ID | Type | Description | Link |
|---|---|---|---|
| RGST04 |
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The purpose of this study is to evaluate the incidence and evolution over-time of co-morbidities in a general dual-chamber pacemaker population (n=2188 patients) through a 2 years follow-up.
The study will focus on the number of patients moving to persistent Atrial Fibrillation as a function of cumulative %Vp (< or >40%), in a general dual-chamber pacemaker population through a 2 year follow-up (n=2188).
The same endpoint will be analyzed in sub populations (Sinus Node Disease and AVB) at 4 years follow up (n=4290).
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| Measure | Description | Time Frame |
|---|---|---|
| Atrial arrhythmias incidence | Two consecutive visits in which atrial fibrillation was present or - at least 22 hours of atrial fibrillation for at least 7 consecutive days or - at least 22 hours of atrial fibrillation per day for fewer than 7 consecutive days if an interruption by electrical or pharmacologic cardioversion occurred | 2 years |
| % ventricular pacing | as measured in the device over the timeframe period | 2 years |
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Inclusion Criteria:
- Patient implanted (primo-implant, replacement, upgrade) with dual chamber pacemaker from less than two months or implanted at inclusion.
Exclusion Criteria:
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The sponsor plans the enrolment of a total of 2188 subjects in this clinical investigation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Cardiovascular Associates | Mesa | Arizona | 85205 | United States | ||
| Mountain Vista Medical Center |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 31, 2025 | |
| Reset | Feb 21, 2025 |
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| Mesa |
| Arizona |
| 85209-3767 |
| United States |
| Pacific Arrhythmia Services | Mesa | Arizona | 91942 | United States |
| Peoria | Arizona | United States |
| Advanced Heart and Vascular Institute | Phoenix | Arizona | 85006 | United States |
| Harishchandra N. Patel, M.D., Inc. | Anaheim | California | 92804 | United States |
| Narayan R. Devaraj, M.D., Inc. | Anaheim | California | 92804 | United States |
| St. Rose Hospital | Fremont | California | 94538 | United States |
| Hanford | California | United States |
| Los Angeles | California | United States |
| Simi Valley Hospital | Simi Valley | California | 93065 | United States |
| Metroform Medical Complex | Newark | Delaware | 19713 | United States |
| Complete Cardiology Care Live Oak Street | New Smyrna Beach | Florida | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Northside Hospital Cardiology | Atlanta | Georgia | United States |
| Northeast Georgia heart Center | Gainesville | Georgia | 30501 | United States |
| Electrophysiology Research Foundation | Warren Township | New Jersey | 07059 | United States |
| Abbas Shehadeh, MD, PA | West Orange | New Jersey | 07052 | United States |
| Low Country Medical Group | Beaufort | North Carolina | 29906 | United States |
| Charlotte | North Carolina | 28204 | United States |
| East Ohio Rag Hospital | Columbus | Ohio | 43205 | United States |
| The Toledo Hospital | Toledo | Ohio | 43615 | United States |
| Toledo Clinic Inc | Toledo | Ohio | United States |
| Lakshimi Mizin Cardiology | Carbondale | Pennsylvania | 18407 | United States |
| Scranton Heart Institute | Clarks Green | Pennsylvania | United States |
| Easton Cardiology | Easton | Pennsylvania | 18042 | United States |
| Coastal Cardiology | Charleston | South Carolina | United States |
| Charleston | South Carolina | United States |
| Columbia Cardiology Consultants | Columbia | South Carolina | 29204 | United States |
| Ocean Cardiology | Murrells Inlet | South Carolina | United States |
| Pawleys Island | South Carolina | United States |
| Victoria Heart and Vascular Center | Victoria | Texas | 77901 | United States |
| John Flynn Private Hospital | Tugun | Queensland | 4224 | Australia |
| Cliniques Sud Luxembourg | Arlon | 6700 | Belgium |
| RHMS Ath - Baudour | Baudour | 7331 | Belgium |
| Hôpital Brugmann | Brussels | 1020 | Belgium |
| vzw Sint-Jozefskliniek | Izegem | Belgium |
| AZ Groeninge | Kortrijk | Belgium |
| UZ Gasthuisberg Leuven | Leuven | 3000 | Belgium |
| Clinique & Maternité Sainte-Elisabeth Namur | Namur | 5000 | Belgium |
| Hôpital de La Tourelle | Verviers | 4800 | Belgium |
| Hotel Dieu de Montreal | Montreal | Canada |
| Maisonneuve-Rosemont | Montreal | Canada |
| Chus-Fleurimont - Hospital | Sherbrooke | Canada |
| Trois-Rivières | Canada |
| Bispebjerg Hospital | Bispebjerg | Denmark |
| Gentofte Hospital | Hellerup | 2900 | Denmark |
| Polyclinique Parc Rambot | Aix-en-Provence | 13611 | France |
| CHG Albi | Albi | France |
| Centre hospitalier de la Région d'Annecy | Annecy | 74011 | France |
| Cabinet médical | Arras | 62000 | France |
| Chu Brest | Brest | 29609 | France |
| CH Brive | Brive-la-Gaillarde | 19312 | France |
| Clinique Ste Marie | Cambrai | France |
| Ch Chaumont | Chaumont | 52014 | France |
| CH Châlon en Champagne | Châlon-en-Champagne | 51005 | France |
| Clinique Bon Secours | Châtellerault | 86100 | France |
| Ch Cherbourg | Cherbourg | 50102 | France |
| HIA Percy | Clamart | 92151 | France |
| CH René Pleven | Dinan | 22100 | France |
| CH Douarnenez | Douarnenez | 29100 | France |
| Centre Cardiologique d'Evecquemont | Évecquemont | 78740 | France |
| CH D'Evreux | Évreux | 27023 | France |
| CMCO | Évry | 91035 | France |
| CH de Firminy | Firminy | 42704 | France |
| Hagondange | 57300 | France |
| CH de la région St Omer | Helfaut | 62570 | France |
| Cabinet de cardiologie | Hénin-Beaumont | 62110 | France |
| Cabinet de cardiologie | Lannion | 22300 | France |
| Centre Hospitalier Pierre Le Damany | Lannion | 22303 | France |
| Cmc Parly Ii | Le Chesnay | 78150 | France |
| CH J. Monod | Le Havre | 76600 | France |
| CH St Philibert | Lomme | 59462 | France |
| CH de Bretagne Sud | Lorient | 56322 | France |
| Ch de Bretagne Sud | Lorient | France |
| Centre Hospitalier de Sambre Avesnois | Maubeuge | 59607 | France |
| Hôpital Ste Blandine | Metz | 57045 | France |
| Clinique Claude Bernard | Metz | 57072 | France |
| Clinique de Montargis | Montargis | 45200 | France |
| Clinique Pont de Chaume | Montauban | 82000 | France |
| Cabinet de Cardiologie | Narbonne | 11100 | France |
| Hopital Privé A. Brillard | Nogent-sur-Marne | 94130 | France |
| Hôpital Lariboisière | Paris | 75475 | France |
| CH Poitiers | Poitiers | France |
| Centre hospitalier général | Roanne | 42328 | France |
| Clinique Saint Hilaire | Rouen | France |
| Centre hospitalier Yves Le Fol | Saint-Brieuc | 22023 | France |
| CCN | Saint-Denis | 93207 | France |
| CHU - Hôpital Nord | Saint-Etienne | 42055 | France |
| H.I.A. Begin | Saint-Mandé | 94160 | France |
| CHG | Saint-Nazaire | 44606 | France |
| CH | Soissons | 02200 | France |
| CH Broussais | St-Malo | France |
| Centre Hospitalier | Tulle | 19012 | France |
| Centre Hospitalier de Valence | Valence | 26953 | France |
| Ch Valenciennes | Valenciennes | 59300 | France |
| CH Vannes - CH Bretagne Atlantique | Vannes | 56017 | France |
| Kardiologische Praxis Dr. Schröter | Alten | 17087 | Germany |
| PRAXIS | Annaberg-Buchholz | 9300 | Germany |
| Praxis Dr. Gerhard BÖHM | Arnstadt | 99310 | Germany |
| Dr. med. Kai-Uwe Westermann | Aschersleben | 06449 | Germany |
| FOWIS e. V., Förderverein für die medizinische Wissenschaft und Schulung | Berlin | 13187 | Germany |
| Praxis Dr. Bott | Berlin | Germany |
| Praxis Schmidt/Engelsing | Berlin | Germany |
| Berlin | Germany |
| Innere Medizin und Kardiologie | Bünde | 32257 | Germany |
| Praxis Dr. Gloes | Chemnitz | 09119 | Germany |
| Praxis Dr. Med Stellmach | Chemnitz | 09126 | Germany |
| Praxis Troeger | Chemnitz | Germany |
| Gesundheitszentrum Im Esc | Dresden | 01277 | Germany |
| Praxis Engelhard Kaiser | Düsseldorf | Germany |
| Kardiologische Praxis | Ebersbach | 02730 | Germany |
| FA fur Innere Medizin/Kardiologie | Eilenburg | 04838 | Germany |
| Klinik Eilenburg | Eilenburg | Germany |
| Kardiologische Praxis | Eschwege | 37269 | Germany |
| Gemeinschaftspraxis Dr. Bemmann, Dr. Sadowski, Dr. Boehme | Frankfurt | 15230 | Germany |
| Kardiocentrum Frankfurt and der Klinik Rotes Kreuz | Frankfurt | 60316 | Germany |
| DRK Krankenhaus Grevesmuehlen | Grevesmühlen | 23936 | Germany |
| Baerenfaenger Dr. Petra Private Practice | Hanau | 63450 | Germany |
| Gemeinschaftspraxis Dr. Loebe - Dr. Weissbrodt | Leipzig | 04103 | Germany |
| FA fur Innere Medizin/Kardiologie | Leipzig | 04107 | Germany |
| Praxis Dr. Andreas Herzfeld | Leipzig | 04209 | Germany |
| Praxis Dr. med. Irina Boran | Leipzig | Germany |
| Praxis Schreiner | Leipzig | Germany |
| Medizin/Kardiologie/Diabetologie | Lichtentanne | 08115 | Germany |
| Staedt. Linikum Medizinische Klinik Lueneburg | Lüneburg | Germany |
| SPENGLER | Machern | 04827 | Germany |
| PRAXIS | Markkleeberg | 04416 | Germany |
| Memmingen | Germany |
| Kardiologische - angiologische Praxis Dr. med. Jörg Walter | Mühlhausen | 99974 | Germany |
| Klinikum Bogenhausen | München | 81925 | Germany |
| Gemeinschaftspraxis Dres.Med.U. Heinrich Und Dr Predel | Nordhausen | 99734 | Germany |
| Praxis für Gefäßmedizin | Nordhausen | 99734 | Germany |
| Praxis Dr. Donaubauer | Oschatz | Germany |
| Praxis Dr. Stuehn-Pfeiffer , Dr. Wilke | Papenburg | 26871 | Germany |
| Med. Martina Trummel Praxis Innere Medizin / Kardiologie | Quedlinburg | 06484 | Germany |
| DRK Krankenhaus Ratzeburg | Ratzeburg | Germany |
| Praxis Dr. Noehring | Schwarzenberg | 08340 | Germany |
| Diakonie Klinikum Schwäbisch Hall GmbH | Schwäbisch Hall | 74523 | Germany |
| Praxis Prof. Frey | Starnberg | 82319 | Germany |
| Praxis Dr. Birkenhagen | Stollberg | 09366 | Germany |
| Sohien und Hufeland Klinikum Weimar Gmbh | Weimar | 9942 | Germany |
| Praxis Dr Lebek | Wunsiedel | 95632 | Germany |
| Praxis Dr. Brode | Zwickau | 08056 | Germany |
| Ospedale San Donato | Arezzo | 52100 | Italy |
| Ospedale Civile di Conegliano | Conegliano | Italy |
| Arcispedale S. Maria Nuova | Florence | 50122 | Italy |
| Ospedale Nuovo San Giovanni di Dio | Florence | Italy |
| Ospedale S. Maria Annunziata | Florence | Italy |
| AOU S.Paolo | Milan | 20142 | Italy |
| Ospedale Valdarno | Montevarchi | Italy |
| Ospedale Sacrocuore - Don Calabria | Negrar | Italy |
| University Hospital of Pisa | Pisa | 56038 | Italy |
| Ospedale OO.OO.San Giovanni e Ruggi d'Aragona | Salerno | 84131 | Italy |
| Shobara Red Cross Hospital | Hiroshima | 727-0013 | Japan |
| Kimitsu Chuo Hospital | Kisarazu | 292-8535 | Japan |
| Yokosuka Kyosai General Hospital | Kyosai | Japan |
| Sakurabashi Watanabe Hospital | Osaka | 530-0001 | Japan |
| Tominaga Hospital | Osaka | 556-0017 | Japan |
| Osaka National Hospital | Osaka | Japan |
| National Hospital Organization Oita Medical Center | Ōita | 870-0263 | Japan |
| Okamura Memorial Hospital | Suntou-gun | 411-0904 | Japan |
| Tokai University Tokyo Hospital | Tokyo | 151-0053 | Japan |
| Tokyo Metropolitan Tama Medical Center | Tokyo | 183-8524 | Japan |
| Aoyama Hospital | Toyokawa | 441-0195 | Japan |
| Yokohama City University Hospital | Yokohama | Japan |
| Gelre Ziekenhuizen | Zutphen | 7207 | Netherlands |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital Marina Salud de Denia | Denia | 03700 | Spain |
| Hospital general de Elda | Elda | Spain |
| H.A. Marcide | Ferrol | Spain |
| Hospital Galdakao | Galdakao | Spain |
| Cabuenes | Gijón | Spain |
| Hospital Universitario San Cecilio | Granada | 18012 | Spain |
| Hospital Rafael Mendez | Lorca | 30800 | Spain |
| Complejo Hospitalario Xeral Calde | Lugo | Spain |
| Hospital 12 de Octubre | Madrid | 28026 | Spain |
| Hospital de Fuenlabrada | Madrid | 28942 | Spain |
| CHOU | Ourense | Spain |
| Hospital Montecelo | Pontevedra | 36071 | Spain |
| Virgen del Rocio | Seville | Spain |
| Joan XXIII | Tarragona | 43007 | Spain |
| Hospital Clínico Universitario | Valencia | 46010 | Spain |
| Hospital Universitario Rio Hortega | Valladolid | Spain |
| Hospital Lluis Alcanyis | Xàtiva | 46800 | Spain |
| Basel | Switzerland |
| Lausanne | Switzerland |
| Ospedale La Carità | Locarno | 6600 | Switzerland |
| Universitaetsspital Zuerich | Zurich | 8091 | Switzerland |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 31, 2025 | Feb 21, 2025 |