Trial Synopsis
Transcription
Trial Synopsis
EMERALD - AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients Status: Active, not recruiting Study Phase: N/A Start Date: March 2010 | Completion Date: January 2019 Condition(s): Atrial Arrhythmia Full Title of Study AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients Overview The purpose of this study is to evaluate the incidence and evolution over-time of comorbidities in a general dual-chamber pacemaker population (n=2188 patients) through a 2 years follow-up. Detailed Description The study will focus on the number of patients moving to persistent Atrial Fibrillation as a function of cumulative %Vp (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). Study Details Study Type: Observational Study Design: Observational Model: Cohort, Time Perspective: Prospective Investigator Details Lead Sponsor: LivaNova Trial Location Details Facility: Southwest Cardiovascular Associates Mesa, United States Facility: Mountain Vista Medical Center Mesa, United States Facility: Pacific Arrhythmia Services Mesa, United States Facility: Peoria, United States Facility: Advanced Heart and Vascular Institute Phoenix, United States Facility: Harishchandra N. Patel, M.D., Inc. Anaheim, United States Facility: Narayan R. Devaraj, M.D., Inc. Anaheim, United States Facility: St. Rose Hospital Fremont, United States Facility: Hanford, United States Facility: Los Angeles, United States Facility: Simi Valley Hospital Simi Valley, United States Facility: Metroform Medical Complex Newark,, United States Facility: Complete Cardiology Care Live Oak Street New Smyrna Beach, United States Facility: Piedmont Hospital Atlanta, United States Facility: Northside Hospital Cardiology Atlanta, United States Facility: Northeast Georgia heart Center Gainesville, United States Facility: Electrophysiology Research Foundation Warren Township, United States Facility: Abbas Shehadeh, MD, PA West Orange, United States Facility: Low Country Medical Group Beaufort, United States Facility: Charlotte, United States Facility: East Ohio Rag Hospital Columbus, United States Facility: The Toledo Hospital Toledo, United States Facility: Toledo Clinic Inc Toledo, United States Facility: Lakshimi Mizin Cardiology Carbondale , Pa, United States Facility: Scranton Heart Institute Clarks Green Pa, United States Facility: Easton Cardiology Easton, United States Facility: Coastal Cardiology Charleston, United States Facility: Charleston, United States Facility: Columbia Cardiology Consultants Columbia, United States Facility: Ocean Cardiology Murrells Inlet, United States Facility: Pawleys Island, United States Facility: Victoria Heart and Vascular Center Victoria, United States Facility: John Flynn Private Hospital Tugun, Australia Facility: Cliniques Sud Luxembourg Arlon, Belgium Facility: RHMS Ath - Baudour Baudour, Belgium Facility: Hôpital Brugmann Brussels, Belgium Facility: vzw Sint-Jozefskliniek Izegem, Belgium Facility: AZ Groeninge Kortrijk, Belgium Facility: UZ Gasthuisberg Leuven Leuven, Belgium Facility: Clinique & Maternité Sainte-Elisabeth Namur Namur, Belgium Facility: Hôpital de La Tourelle Verviers, Belgium Facility: Hotel Dieu de Montreal Montreal, Canada Facility: Maisonneuve-Rosemont Montreal, Canada Facility: Chus-Fleurimont - Hospital Sherbrooke, Canada Facility: Trois-Rivieres, Canada Facility: Bispebjerg Hospital Bispebjerg, Denmark Facility: Gentofte Hospital Hellerup, Denmark Facility: Polyclinique Parc Rambot Aix-en-Provence, France Facility: CHG Albi Albi, France Facility: Centre hospitalier de la Région d'Annecy Annecy, France Facility: Cabinet médical Arras, France Facility: Chu Brest Brest, France Facility: CH Brive Brive La Gaillarde, France Facility: Clinique Ste Marie Cambrai, France Facility: Clinique Bon Secours Chatellerault, France Facility: Ch Chaumont Chaumont, France Facility: Ch Cherbourg Cherbourg, France Facility: CH Châlon en Champagne Châlon-en-Champagne, France Facility: HIA Percy Clamart, France Facility: CH René Pleven Dinan, France Facility: CH Douarnenez Douarnenez, France Facility: Centre Cardiologique d'Evecquemont Evecquemont, France Facility: CH D'Evreux Evreux, France Facility: CMCO Evry, France Facility: CH de Firminy Firminy, France Facility: Hagondange, France Facility: CH de la région St Omer Helfaut, France Facility: Cabinet de cardiologie Henin Beaumont, France Facility: Cabinet de cardiologie Lannion, France Facility: Centre Hospitalier Pierre Le Damany Lannion, France Facility: Cmc Parly Ii Le Chesnay, France Facility: CH J. Monod Le Havre, France Facility: CH St Philibert Lomme, France Facility: CH de Bretagne Sud Lorient, France Facility: Ch de Bretagne Sud Lorient, France Facility: Centre Hospitalier de Sambre Avesnois Maubeuge, France Facility: Hôpital Ste Blandine Metz, France Facility: Clinique Claude Bernard Metz, France Facility: Clinique de Montargis Montargis, France Facility: Clinique Pont de Chaume Montauban, France Facility: Cabinet de Cardiologie Narbonne, France Facility: Hopital Privé A. Brillard Nogent Sur Marne, France Facility: Hôpital Lariboisière Paris, France Facility: CH Poitiers Poitiers, France Facility: Centre hospitalier général Roanne, France Facility: Clinique Saint Hilaire Rouen, France Facility: Centre hospitalier Yves Le Fol Saint Brieuc, France Facility: CCN Saint Denis, France Facility: CHU - Hôpital Nord Saint Etienne, France Facility: CH Broussais Saint Malo, France Facility: H.I.A. Begin Saint Mande, France Facility: CH Soissons, France Facility: CHG St Nazaire, France Facility: Centre Hospitalier Tulle, France Facility: Centre Hospitalier de Valence Valence, France Facility: Ch Valenciennes Valenciennes, France Facility: CH Vannes - CH Bretagne Atlantique Vannes, France Facility: Kardiologische Praxis Dr. Schröter Alten, Germany Facility: PRAXIS Annaberg-buchholz, Germany Facility: Praxis Dr. Gerhard BÖHM Arnstadt, Germany Facility: Dr. med. Kai-Uwe Westermann Aschersleben, Germany Facility: FOWIS e. V., Förderverein für die medizinische Wissenschaft und Schulung Berlin, Germany Facility: Praxis Dr. Bott Berlin, Germany Facility: Praxis Schmidt/Engelsing Berlin, Germany Facility: Berlin, Germany Facility: Innere Medizin und Kardiologie Bunde, Germany Facility: Praxis Dr. Gloes Chemnitz, Germany Facility: Praxis Dr. Med Stellmach Chemnitz, Germany Facility: Praxis Troeger Chemnitz, Germany Facility: Gesundheitszentrum Im Esc Dresden, Germany Facility: Praxis Engelhard Kaiser Dusseldorf, Germany Facility: Kardiologische Praxis Ebersbach, Germany Facility: FA fur Innere Medizin/Kardiologie Eilenburg, Germany Facility: Klinik Eilenburg Eilenburg, Germany Facility: Kardiologische Praxis Eschwege, Germany Facility: Gemeinschaftspraxis Dr. Bemmann, Dr. Sadowski, Dr. Boehme Frankfurt, Germany Facility: Kardiocentrum Frankfurt and der Klinik Rotes Kreuz Frankfurt, Germany Facility: DRK Krankenhaus Grevesmuehlen Grevesmuehlen, Germany Facility: Baerenfaenger Dr. Petra Private Practice Hanau, Germany Facility: Gemeinschaftspraxis Dr. Loebe - Dr. Weissbrodt Leipzig, Germany Facility: FA fur Innere Medizin/Kardiologie Leipzig, Germany Facility: Praxis Dr. Andreas Herzfeld Leipzig, Germany Facility: Praxis Dr. med. Irina Boran Leipzig, Germany Facility: Praxis Schreiner Leipzig, Germany Facility: Medizin/Kardiologie/Diabetologie Lichtentanne, Germany Facility: Staedt. Linikum Medizinische Klinik Lueneburg Lueneburg, Germany Facility: SPENGLER Machern, Germany Facility: PRAXIS Markkleeberg, Germany Facility: Memmingen, Germany Facility: Kardiologische - angiologische Praxis Dr. med. Jörg Walter Mühlhausen, Germany Facility: Klinikum Bogenhausen München, Germany Facility: Gemeinschaftspraxis Dres.Med.U. Heinrich Und Dr Predel Nordhausen, Germany Facility: Praxis für Gefäßmedizin Nordhausen, Germany Facility: Praxis Dr. Donaubauer Oschatz, Germany Facility: Praxis Dr. Stuehn-Pfeiffer , Dr. Wilke Papenburg, Germany Facility: Med. Martina Trummel Praxis Innere Medizin / Kardiologie Quedlinburg, Germany Facility: DRK Krankenhaus Ratzeburg Ratzeburg, Germany Facility: Praxis Dr. Noehring Schwarzenberg, Germany Facility: Diakonie Klinikum Schwäbisch Hall GmbH Schwäbisch Hall, Germany Facility: Praxis Prof. Frey Starnberg, Germany Facility: Praxis Dr. Birkenhagen Stollberg, Germany Facility: Sohien und Hufeland Klinikum Weimar Gmbh Weimar, Germany Facility: Praxis Dr Lebek Wunsiedel, Germany Facility: Praxis Dr. Brode Zwickau, Germany Facility: Ospedale San Donato Arezzo, Italy Facility: Ospedale Civile di Conegliano Conegliano, Italy Facility: Arcispedale S. Maria Nuova Firenze, Italy Facility: Ospedale Nuovo San Giovanni di Dio Firenze, Italy Facility: Ospedale S. Maria Annunziata Firenze, Italy Facility: AOU S.Paolo Milano, Italy Facility: Ospedale Valdarno Montevarchi, Italy Facility: Ospedale Sacrocuore - Don Calabria Negrar, Italy Facility: University Hospital of Pisa Pisa, Italy Facility: Ospedale OO.OO.San Giovanni e Ruggi d'Aragona Salerno, Italy Facility: Shobara Red Cross Hospital Hiroshima, Japan Facility: Kimitsu Chuo Hospital Kisarazu- city, Japan Facility: Yokosuka Kyosai General Hospital Kyosai, Japan Facility: National Hospital Organization Oita Medical Center Oita City, Japan Facility: Tominaga Hospital Osaka-shi, Japan Facility: Sakurabashi Watanabe Hospital Osaka, Japan Facility: Osaka National Hospital Osaka, Japan Facility: Okamura Memorial Hospital Suntou-gun, Japan Facility: Tokai University Tokyo Hospital Tokyo, Japan Facility: Tokyo Metropolitan Tama Medical Center Tokyo, Japan Facility: Aoyama Hospital Toyokawa City, Japan Facility: Yokohama City University Hospital Yokohama, Japan Facility: Gelre Ziekenhuizen Zutphen, Netherlands Facility: Hospital General Universitario de Alicante Alicante, Spain Facility: Hospital Germans Trias i Pujol Badalona, Spain Facility: Hospital Marina Salud de Denia Denia, Spain Facility: Hospital general de Elda Elda, Spain Facility: H.A. Marcide Ferrol, Spain Facility: Hospital Galdakao Galdakao, Spain Facility: Cabuenes Gijon, Spain Facility: Hospital Universitario San Cecilio Granada, Spain Facility: Hospital Rafael Mendez Lorca, Spain Facility: Complejo Hospitalario Xeral Calde Lugo, Spain Facility: Hospital 12 de Octubre Madrid, Spain Facility: Hospital de Fuenlabrada Madrid, Spain Facility: CHOU Ourense, Spain Facility: Hospital Montecelo Pontevedra, Spain Facility: Virgen del Rocio Sevilla, Spain Facility: Joan XXIII Tarragona, Spain Facility: Hospital Clínico Universitario Valencia, Spain Facility: Hospital Universitario Rio Hortega Valladolid, Spain Facility: Hospital Lluis Alcanyis Xativa, Spain Facility: Basel, Switzerland Facility: Lausanne, Switzerland Facility: Ospedale La Carità Locarno, Switzerland Facility: Universitaetsspital Zuerich Zuerich, Switzerland Information Source ID Number: RGST04-EMERALD Study NCT Identifier: NCT01188356 Health Authority: Array Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT01188356 ClinicalTrials.gov processed this data on September 30, 2016 Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. 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