EMERALD - AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
EMERALD
AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
2 other identifiers
observational
4,350
12 countries
190
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2010
Longer than P75 for all trials
190 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 24, 2010
CompletedFirst Posted
Study publicly available on registry
August 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2017
CompletedMarch 25, 2019
March 1, 2019
5.1 years
August 24, 2010
March 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Eligibility Criteria
The sponsor plans the enrolment of a total of 2188 subjects in this clinical investigation.
You may not qualify if:
- Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines
- Permanent or persistent atrial tachyarrhythmia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MicroPort CRMlead
Study Sites (190)
Southwest Cardiovascular Associates
Mesa, Arizona, 85205, United States
Mountain Vista Medical Center
Mesa, Arizona, 85209-3767, United States
Pacific Arrhythmia Services
Mesa, Arizona, 91942, United States
Unknown Facility
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
Unknown Facility
Hanford, California, United States
Unknown Facility
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
Unknown Facility
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
Unknown Facility
Charleston, South Carolina, United States
Columbia Cardiology Consultants
Columbia, South Carolina, 29204, United States
Ocean Cardiology
Murrells Inlet, South Carolina, United States
Unknown Facility
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
Unknown Facility
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
Unknown Facility
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
Unknown Facility
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
Unknown Facility
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
Unknown Facility
Basel, Switzerland
Unknown Facility
Lausanne, Switzerland
Ospedale La Carità
Locarno, 6600, Switzerland
Universitaetsspital Zuerich
Zurich, 8091, Switzerland
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2010
First Posted
August 25, 2010
Study Start
March 1, 2010
Primary Completion
April 1, 2015
Study Completion
August 31, 2017
Last Updated
March 25, 2019
Record last verified: 2019-03