EMERALD - AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients

NCT ID: NCT01188356

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Atrial Arrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

* Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines
* Permanent or persistent atrial tachyarrhythmia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MicroPort CRM

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Southwest Cardiovascular Associates

Mesa, Arizona, United States

Site Status

Mountain Vista Medical Center

Mesa, Arizona, United States

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Pacific Arrhythmia Services

Mesa, Arizona, United States

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Peoria, Arizona, United States

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Advanced Heart and Vascular Institute

Phoenix, Arizona, United States

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Harishchandra N. Patel, M.D., Inc.

Anaheim, California, United States

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Narayan R. Devaraj, M.D., Inc.

Anaheim, California, United States

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St. Rose Hospital

Fremont, California, United States

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Hanford, California, United States

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Los Angeles, California, United States

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Simi Valley Hospital

Simi Valley, California, United States

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Metroform Medical Complex

Newark, Delaware, United States

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Complete Cardiology Care Live Oak Street

New Smyrna Beach, Florida, United States

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Piedmont Hospital

Atlanta, Georgia, United States

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Northside Hospital Cardiology

Atlanta, Georgia, United States

Site Status

Northeast Georgia heart Center

Gainesville, Georgia, United States

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Electrophysiology Research Foundation

Warren Township, New Jersey, United States

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Abbas Shehadeh, MD, PA

West Orange, New Jersey, United States

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Low Country Medical Group

Beaufort, North Carolina, United States

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Charlotte, North Carolina, United States

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East Ohio Rag Hospital

Columbus, Ohio, United States

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The Toledo Hospital

Toledo, Ohio, United States

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Toledo Clinic Inc

Toledo, Ohio, United States

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Lakshimi Mizin Cardiology

Carbondale, Pennsylvania, United States

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Scranton Heart Institute

Clarks Green, Pennsylvania, United States

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Easton Cardiology

Easton, Pennsylvania, United States

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Coastal Cardiology

Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Columbia Cardiology Consultants

Columbia, South Carolina, United States

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Ocean Cardiology

Murrells Inlet, South Carolina, United States

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Pawleys Island, South Carolina, United States

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Victoria Heart and Vascular Center

Victoria, Texas, United States

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John Flynn Private Hospital

Tugun, Queensland, Australia

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Cliniques Sud Luxembourg

Arlon, , Belgium

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RHMS Ath - Baudour

Baudour, , Belgium

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Hôpital Brugmann

Brussels, , Belgium

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vzw Sint-Jozefskliniek

Izegem, , Belgium

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AZ Groeninge

Kortrijk, , Belgium

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UZ Gasthuisberg Leuven

Leuven, , Belgium

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Clinique & Maternité Sainte-Elisabeth Namur

Namur, , Belgium

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Hôpital de La Tourelle

Verviers, , Belgium

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Hotel Dieu de Montreal

Montreal, , Canada

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Maisonneuve-Rosemont

Montreal, , Canada

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Chus-Fleurimont - Hospital

Sherbrooke, , Canada

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Trois-Rivières, , Canada

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Bispebjerg Hospital

Bispebjerg, , Denmark

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Gentofte Hospital

Hellerup, , Denmark

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Polyclinique Parc Rambot

Aix-en-Provence, , France

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CHG Albi

Albi, , France

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Centre hospitalier de la Région d'Annecy

Annecy, , France

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Cabinet médical

Arras, , France

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Chu Brest

Brest, , France

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CH Brive

Brive-la-Gaillarde, , France

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Clinique Ste Marie

Cambrai, , France

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Ch Chaumont

Chaumont, , France

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CH Châlon en Champagne

Châlon-en-Champagne, , France

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Clinique Bon Secours

Châtellerault, , France

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Ch Cherbourg

Cherbourg, , France

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HIA Percy

Clamart, , France

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CH René Pleven

Dinan, , France

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CH Douarnenez

Douarnenez, , France

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Centre Cardiologique d'Evecquemont

Évecquemont, , France

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CH D'Evreux

Évreux, , France

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CMCO

Évry, , France

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CH de Firminy

Firminy, , France

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Hagondange, , France

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CH de la région St Omer

Helfaut, , France

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Cabinet de cardiologie

Hénin-Beaumont, , France

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Cabinet de cardiologie

Lannion, , France

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Centre Hospitalier Pierre Le Damany

Lannion, , France

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Cmc Parly Ii

Le Chesnay, , France

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CH J. Monod

Le Havre, , France

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CH St Philibert

Lomme, , France

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CH de Bretagne Sud

Lorient, , France

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Ch de Bretagne Sud

Lorient, , France

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Centre Hospitalier de Sambre Avesnois

Maubeuge, , France

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Hôpital Ste Blandine

Metz, , France

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Clinique Claude Bernard

Metz, , France

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Clinique de Montargis

Montargis, , France

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Clinique Pont de Chaume

Montauban, , France

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Cabinet de Cardiologie

Narbonne, , France

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Hopital Privé A. Brillard

Nogent-sur-Marne, , France

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Hôpital Lariboisière

Paris, , France

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CH Poitiers

Poitiers, , France

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Centre hospitalier général

Roanne, , France

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Clinique Saint Hilaire

Rouen, , France

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Centre hospitalier Yves Le Fol

Saint-Brieuc, , France

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CCN

Saint-Denis, , France

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CHU - Hôpital Nord

Saint-Etienne, , France

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H.I.A. Begin

Saint-Mandé, , France

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CHG

Saint-Nazaire, , France

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CH

Soissons, , France

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CH Broussais

St-Malo, , France

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Centre Hospitalier

Tulle, , France

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Centre Hospitalier de Valence

Valence, , France

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Ch Valenciennes

Valenciennes, , France

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CH Vannes - CH Bretagne Atlantique

Vannes, , France

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Kardiologische Praxis Dr. Schröter

Alten, , Germany

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PRAXIS

Annaberg-Buchholz, , Germany

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Praxis Dr. Gerhard BÖHM

Arnstadt, , Germany

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Dr. med. Kai-Uwe Westermann

Aschersleben, , Germany

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FOWIS e. V., Förderverein für die medizinische Wissenschaft und Schulung

Berlin, , Germany

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Praxis Dr. Bott

Berlin, , Germany

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Praxis Schmidt/Engelsing

Berlin, , Germany

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Berlin, , Germany

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Innere Medizin und Kardiologie

Bünde, , Germany

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Praxis Dr. Gloes

Chemnitz, , Germany

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Praxis Dr. Med Stellmach

Chemnitz, , Germany

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Praxis Troeger

Chemnitz, , Germany

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Gesundheitszentrum Im Esc

Dresden, , Germany

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Praxis Engelhard Kaiser

Düsseldorf, , Germany

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Kardiologische Praxis

Ebersbach, , Germany

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FA fur Innere Medizin/Kardiologie

Eilenburg, , Germany

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Klinik Eilenburg

Eilenburg, , Germany

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Kardiologische Praxis

Eschwege, , Germany

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Gemeinschaftspraxis Dr. Bemmann, Dr. Sadowski, Dr. Boehme

Frankfurt, , Germany

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Kardiocentrum Frankfurt and der Klinik Rotes Kreuz

Frankfurt, , Germany

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DRK Krankenhaus Grevesmuehlen

Grevesmühlen, , Germany

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Baerenfaenger Dr. Petra Private Practice

Hanau, , Germany

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Gemeinschaftspraxis Dr. Loebe - Dr. Weissbrodt

Leipzig, , Germany

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FA fur Innere Medizin/Kardiologie

Leipzig, , Germany

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Praxis Dr. Andreas Herzfeld

Leipzig, , Germany

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Praxis Dr. med. Irina Boran

Leipzig, , Germany

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Praxis Schreiner

Leipzig, , Germany

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Medizin/Kardiologie/Diabetologie

Lichtentanne, , Germany

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Staedt. Linikum Medizinische Klinik Lueneburg

Lüneburg, , Germany

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SPENGLER

Machern, , Germany

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PRAXIS

Markkleeberg, , Germany

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Memmingen, , Germany

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Kardiologische - angiologische Praxis Dr. med. Jörg Walter

Mühlhausen, , Germany

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Klinikum Bogenhausen

München, , Germany

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Gemeinschaftspraxis Dres.Med.U. Heinrich Und Dr Predel

Nordhausen, , Germany

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Praxis für Gefäßmedizin

Nordhausen, , Germany

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Praxis Dr. Donaubauer

Oschatz, , Germany

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Praxis Dr. Stuehn-Pfeiffer , Dr. Wilke

Papenburg, , Germany

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Med. Martina Trummel Praxis Innere Medizin / Kardiologie

Quedlinburg, , Germany

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DRK Krankenhaus Ratzeburg

Ratzeburg, , Germany

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Praxis Dr. Noehring

Schwarzenberg, , Germany

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Diakonie Klinikum Schwäbisch Hall GmbH

Schwäbisch Hall, , Germany

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Praxis Prof. Frey

Starnberg, , Germany

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Praxis Dr. Birkenhagen

Stollberg, , Germany

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Sohien und Hufeland Klinikum Weimar Gmbh

Weimar, , Germany

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Praxis Dr Lebek

Wunsiedel, , Germany

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Praxis Dr. Brode

Zwickau, , Germany

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Ospedale San Donato

Arezzo, , Italy

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Ospedale Civile di Conegliano

Conegliano, , Italy

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Arcispedale S. Maria Nuova

Florence, , Italy

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Ospedale Nuovo San Giovanni di Dio

Florence, , Italy

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Ospedale S. Maria Annunziata

Florence, , Italy

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AOU S.Paolo

Milan, , Italy

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Ospedale Valdarno

Montevarchi, , Italy

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Ospedale Sacrocuore - Don Calabria

Negrar, , Italy

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University Hospital of Pisa

Pisa, , Italy

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Ospedale OO.OO.San Giovanni e Ruggi d'Aragona

Salerno, , Italy

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Shobara Red Cross Hospital

Hiroshima, , Japan

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Kimitsu Chuo Hospital

Kisarazu, , Japan

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Yokosuka Kyosai General Hospital

Kyosai, , Japan

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Sakurabashi Watanabe Hospital

Osaka, , Japan

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Tominaga Hospital

Osaka, , Japan

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Osaka National Hospital

Osaka, , Japan

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National Hospital Organization Oita Medical Center

Ōita, , Japan

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Okamura Memorial Hospital

Suntou-gun, , Japan

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Tokai University Tokyo Hospital

Tokyo, , Japan

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Tokyo Metropolitan Tama Medical Center

Tokyo, , Japan

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Aoyama Hospital

Toyokawa, , Japan

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Yokohama City University Hospital

Yokohama, , Japan

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Gelre Ziekenhuizen

Zutphen, , Netherlands

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Hospital General Universitario de Alicante

Alicante, , Spain

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Hospital Germans Trias i Pujol

Badalona, , Spain

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Hospital Marina Salud de Denia

Denia, , Spain

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Hospital general de Elda

Elda, , Spain

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H.A. Marcide

Ferrol, , Spain

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Hospital Galdakao

Galdakao, , Spain

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Cabuenes

Gijón, , Spain

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Hospital Universitario San Cecilio

Granada, , Spain

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Hospital Rafael Mendez

Lorca, , Spain

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Complejo Hospitalario Xeral Calde

Lugo, , Spain

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Hospital 12 de Octubre

Madrid, , Spain

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Hospital de Fuenlabrada

Madrid, , Spain

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CHOU

Ourense, , Spain

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Hospital Montecelo

Pontevedra, , Spain

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Virgen del Rocio

Seville, , Spain

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Joan XXIII

Tarragona, , Spain

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Hospital Clínico Universitario

Valencia, , Spain

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Hospital Universitario Rio Hortega

Valladolid, , Spain

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Hospital Lluis Alcanyis

Xàtiva, , Spain

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Basel, , Switzerland

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Lausanne, , Switzerland

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Ospedale La Carità

Locarno, , Switzerland

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Universitaetsspital Zuerich

Zurich, , Switzerland

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Countries

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United States Australia Belgium Canada Denmark France Germany Italy Japan Netherlands Spain Switzerland

Other Identifiers

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RGST04

Identifier Type: -

Identifier Source: secondary_id

RGST04-EMERALD Study

Identifier Type: -

Identifier Source: org_study_id

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