Atrial Arrhythmia Clinical Trial
— EMERALDOfficial title:
AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
| Verified date | March 2019 |
| Source | MicroPort CRM |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 4350 |
| Est. completion date | August 31, 2017 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patient implanted (primo-implant, replacement, upgrade) with dual chamber pacemaker from less than two months or implanted at inclusion. Exclusion Criteria: - Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines - Permanent or persistent atrial tachyarrhythmia |
| Country | Name | City | State |
|---|---|---|---|
| Australia | John Flynn Private Hospital | Tugun | Queensland |
| Belgium | Cliniques Sud Luxembourg | Arlon | |
| Belgium | RHMS Ath - Baudour | Baudour | |
| Belgium | Hôpital Brugmann | Brussels | |
| Belgium | vzw Sint-Jozefskliniek | Izegem | |
| Belgium | AZ Groeninge | Kortrijk | |
| Belgium | UZ Gasthuisberg Leuven | Leuven | |
| Belgium | Clinique & Maternité Sainte-Elisabeth Namur | Namur | |
| Belgium | Hôpital de La Tourelle | Verviers | |
| Canada | Hotel Dieu de Montreal | Montreal | |
| Canada | Maisonneuve-Rosemont | Montreal | |
| Canada | Chus-Fleurimont - Hospital | Sherbrooke | |
| Denmark | Bispebjerg Hospital | Bispebjerg | |
| Denmark | Gentofte Hospital | Hellerup | |
| France | Polyclinique Parc Rambot | Aix-en-Provence | |
| France | CHG Albi | Albi | |
| France | Centre hospitalier de la Région d'Annecy | Annecy | |
| France | Cabinet médical | Arras | |
| France | Chu Brest | Brest | |
| France | CH Brive | Brive La Gaillarde | |
| France | Clinique Ste Marie | Cambrai | |
| France | CH Châlon en Champagne | Châlon-en-Champagne | |
| France | Clinique Bon Secours | Chatellerault | |
| France | Ch Chaumont | Chaumont | |
| France | Ch Cherbourg | Cherbourg | |
| France | HIA Percy | Clamart | |
| France | CH René Pleven | Dinan | |
| France | CH Douarnenez | Douarnenez | |
| France | Centre Cardiologique d'Evecquemont | Evecquemont | |
| France | CH D'Evreux | Evreux | |
| France | CMCO | Evry | |
| France | CH de Firminy | Firminy | |
| France | CH de la région St Omer | Helfaut | |
| France | Cabinet de cardiologie | Henin Beaumont | |
| France | Cabinet de cardiologie | Lannion | |
| France | Centre Hospitalier Pierre Le Damany | Lannion | |
| France | Cmc Parly Ii | Le Chesnay | |
| France | CH J. Monod | Le Havre | |
| France | CH St Philibert | Lomme | |
| France | CH de Bretagne Sud | Lorient | |
| France | Ch de Bretagne Sud | Lorient | |
| France | Centre Hospitalier de Sambre Avesnois | Maubeuge | |
| France | Clinique Claude Bernard | Metz | |
| France | Hôpital Ste Blandine | Metz | |
| France | Clinique de Montargis | Montargis | |
| France | Clinique Pont de Chaume | Montauban | |
| France | Cabinet de Cardiologie | Narbonne | |
| France | Hopital Privé A. Brillard | Nogent Sur Marne | |
| France | Hôpital Lariboisière | Paris | |
| France | CH Poitiers | Poitiers | |
| France | Centre hospitalier général | Roanne | |
| France | Clinique Saint Hilaire | Rouen | |
| France | Centre hospitalier Yves Le Fol | Saint Brieuc | |
| France | CCN | Saint Denis | |
| France | CHU - Hôpital Nord | Saint Etienne | |
| France | CH Broussais | Saint Malo | |
| France | H.I.A. Begin | Saint Mande | |
| France | CH | Soissons | |
| France | CHG | St Nazaire | |
| France | Centre Hospitalier | Tulle | |
| France | Centre Hospitalier de Valence | Valence | |
| France | Ch Valenciennes | Valenciennes | |
| France | CH Vannes - CH Bretagne Atlantique | Vannes | |
| Germany | Kardiologische Praxis Dr. Schröter | Alten | |
| Germany | PRAXIS | Annaberg-buchholz | |
| Germany | Praxis Dr. Gerhard BÖHM | Arnstadt | |
| Germany | Dr. med. Kai-Uwe Westermann | Aschersleben | |
| Germany | FOWIS e. V., Förderverein für die medizinische Wissenschaft und Schulung | Berlin | |
| Germany | Praxis Dr. Bott | Berlin | |
| Germany | Praxis Schmidt/Engelsing | Berlin | |
| Germany | Innere Medizin und Kardiologie | Bunde | |
| Germany | Praxis Dr. Gloes | Chemnitz | |
| Germany | Praxis Dr. Med Stellmach | Chemnitz | |
| Germany | Praxis Troeger | Chemnitz | |
| Germany | Gesundheitszentrum Im Esc | Dresden | |
| Germany | Praxis Engelhard Kaiser | Dusseldorf | |
| Germany | Kardiologische Praxis | Ebersbach | |
| Germany | FA fur Innere Medizin/Kardiologie | Eilenburg | |
| Germany | Klinik Eilenburg | Eilenburg | |
| Germany | Kardiologische Praxis | Eschwege | |
| Germany | Gemeinschaftspraxis Dr. Bemmann, Dr. Sadowski, Dr. Boehme | Frankfurt | |
| Germany | Kardiocentrum Frankfurt and der Klinik Rotes Kreuz | Frankfurt | |
| Germany | DRK Krankenhaus Grevesmuehlen | Grevesmuehlen | |
| Germany | Baerenfaenger Dr. Petra Private Practice | Hanau | |
| Germany | FA fur Innere Medizin/Kardiologie | Leipzig | |
| Germany | Gemeinschaftspraxis Dr. Loebe - Dr. Weissbrodt | Leipzig | |
| Germany | Praxis Dr. Andreas Herzfeld | Leipzig | |
| Germany | Praxis Dr. med. Irina Boran | Leipzig | |
| Germany | Praxis Schreiner | Leipzig | |
| Germany | Medizin/Kardiologie/Diabetologie | Lichtentanne | |
| Germany | Staedt. Linikum Medizinische Klinik Lueneburg | Lueneburg | |
| Germany | SPENGLER | Machern | |
| Germany | PRAXIS | Markkleeberg | |
| Germany | Kardiologische - angiologische Praxis Dr. med. Jörg Walter | Mühlhausen | |
| Germany | Klinikum Bogenhausen | München | |
| Germany | Gemeinschaftspraxis Dres.Med.U. Heinrich Und Dr Predel | Nordhausen | |
| Germany | Praxis für Gefäßmedizin | Nordhausen | |
| Germany | Praxis Dr. Donaubauer | Oschatz | |
| Germany | Praxis Dr. Stuehn-Pfeiffer , Dr. Wilke | Papenburg | |
| Germany | Med. Martina Trummel Praxis Innere Medizin / Kardiologie | Quedlinburg | |
| Germany | DRK Krankenhaus Ratzeburg | Ratzeburg | |
| Germany | Diakonie Klinikum Schwäbisch Hall GmbH | Schwäbisch Hall | |
| Germany | Praxis Dr. Noehring | Schwarzenberg | |
| Germany | Praxis Prof. Frey | Starnberg | |
| Germany | Praxis Dr. Birkenhagen | Stollberg | |
| Germany | Sohien und Hufeland Klinikum Weimar Gmbh | Weimar | |
| Germany | Praxis Dr Lebek | Wunsiedel | |
| Germany | Praxis Dr. Brode | Zwickau | |
| Italy | Ospedale San Donato | Arezzo | |
| Italy | Ospedale Civile di Conegliano | Conegliano | |
| Italy | Arcispedale S. Maria Nuova | Firenze | |
| Italy | Ospedale Nuovo San Giovanni di Dio | Firenze | |
| Italy | Ospedale S. Maria Annunziata | Firenze | |
| Italy | AOU S.Paolo | Milano | |
| Italy | Ospedale Valdarno | Montevarchi | |
| Italy | Ospedale Sacrocuore - Don Calabria | Negrar | |
| Italy | University Hospital of Pisa | Pisa | |
| Italy | Ospedale OO.OO.San Giovanni e Ruggi d'Aragona | Salerno | |
| Japan | Shobara Red Cross Hospital | Hiroshima | |
| Japan | Kimitsu Chuo Hospital | Kisarazu- city | |
| Japan | Yokosuka Kyosai General Hospital | Kyosai | |
| Japan | National Hospital Organization Oita Medical Center | Oita City | |
| Japan | Osaka National Hospital | Osaka | |
| Japan | Sakurabashi Watanabe Hospital | Osaka | |
| Japan | Tominaga Hospital | Osaka-shi | |
| Japan | Okamura Memorial Hospital | Suntou-gun | |
| Japan | Tokai University Tokyo Hospital | Tokyo | |
| Japan | Tokyo Metropolitan Tama Medical Center | Tokyo | |
| Japan | Aoyama Hospital | Toyokawa City | |
| Japan | Yokohama City University Hospital | Yokohama | |
| Netherlands | Gelre Ziekenhuizen | Zutphen | |
| Spain | Hospital General Universitario de Alicante | Alicante | |
| Spain | Hospital Germans Trias i Pujol | Badalona | |
| Spain | Hospital Marina Salud de Denia | Denia | |
| Spain | Hospital general de Elda | Elda | |
| Spain | H.A. Marcide | Ferrol | |
| Spain | Hospital Galdakao | Galdakao | |
| Spain | Cabuenes | Gijon | |
| Spain | Hospital Universitario San Cecilio | Granada | |
| Spain | Hospital Rafael Mendez | Lorca | |
| Spain | Complejo Hospitalario Xeral Calde | Lugo | |
| Spain | Hospital 12 de Octubre | Madrid | |
| Spain | Hospital de Fuenlabrada | Madrid | |
| Spain | CHOU | Ourense | |
| Spain | Hospital Montecelo | Pontevedra | |
| Spain | Virgen del Rocio | Sevilla | |
| Spain | Joan XXIII | Tarragona | |
| Spain | Hospital Clínico Universitario | Valencia | |
| Spain | Hospital Universitario Rio Hortega | Valladolid | |
| Spain | Hospital Lluis Alcanyis | Xativa | |
| Switzerland | Ospedale La Carità | Locarno | |
| Switzerland | Universitaetsspital Zuerich | Zuerich | |
| United States | Harishchandra N. Patel, M.D., Inc. | Anaheim | California |
| United States | Narayan R. Devaraj, M.D., Inc. | Anaheim | California |
| United States | Northside Hospital Cardiology | Atlanta | Georgia |
| United States | Piedmont Hospital | Atlanta | Georgia |
| United States | Low Country Medical Group | Beaufort | North Carolina |
| United States | Lakshimi Mizin Cardiology | Carbondale | Pennsylvania |
| United States | Coastal Cardiology | Charleston | South Carolina |
| United States | Scranton Heart Institute | Clarks Green | Pennsylvania |
| United States | Columbia Cardiology Consultants | Columbia | South Carolina |
| United States | East Ohio Rag Hospital | Columbus | Ohio |
| United States | Easton Cardiology | Easton | Pennsylvania |
| United States | St. Rose Hospital | Fremont | California |
| United States | Northeast Georgia heart Center | Gainesville | Georgia |
| United States | Mountain Vista Medical Center | Mesa | Arizona |
| United States | Pacific Arrhythmia Services | Mesa | Arizona |
| United States | Southwest Cardiovascular Associates | Mesa | Arizona |
| United States | Ocean Cardiology | Murrells Inlet | South Carolina |
| United States | Complete Cardiology Care Live Oak Street | New Smyrna Beach | Florida |
| United States | Metroform Medical Complex | Newark | Delaware |
| United States | Advanced Heart and Vascular Institute | Phoenix | Arizona |
| United States | Simi Valley Hospital | Simi Valley | California |
| United States | The Toledo Hospital | Toledo | Ohio |
| United States | Toledo Clinic Inc | Toledo | Ohio |
| United States | Victoria Heart and Vascular Center | Victoria | Texas |
| United States | Electrophysiology Research Foundation | Warren | New Jersey |
| United States | Abbas Shehadeh, MD, PA | West Orange | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| MicroPort CRM |
United States, Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | % ventricular pacing | as measured in the device over the timeframe period | 2 years |
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