Atrial ArrhythmiaEMERALDNCT01188356
EMERALD - AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
An observational study of Atrial Arrhythmia, run by MicroPort CRM at 190 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Arrhythmia
- How many people
- 4,350 participants
- Where
- 190 sitesin 12 countries
- Study dates
- Mar 2010to 31 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sponsor plans the enrolment of a total of 2188 subjects in this clinical investigation.
Who may be able to join
- Patient implanted (primo-implant, replacement, upgrade) with dual chamber pacemaker from less than two months or implanted at inclusion.
Who cannot join
- Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines
- Permanent or persistent atrial tachyarrhythmia
Trial locations and contacts
190 sites in 12 countries.
190 sites in 12 countries
France50 sites
Polyclinique Parc Rambot
Aix-en-Provence, 13611
CHG Albi
Albi
Centre hospitalier de la Région d'Annecy
Annecy, 74011
Cabinet médical
Arras, 62000
Chu Brest
Brest, 29609
CH Brive
Brive-la-Gaillarde, 19312
Clinique Ste Marie
Cambrai
CH Châlon en Champagne
Châlon-en-Champagne, 51005
Clinique Bon Secours
Châtellerault, 86100
Ch Chaumont
Chaumont, 52014
Ch Cherbourg
Cherbourg, 50102
HIA Percy
Clamart, 92151
CH René Pleven
Dinan, 22100
CH Douarnenez
Douarnenez, 29100
Centre Cardiologique d'Evecquemont
Évecquemont, 78740
CH D'Evreux
Évreux, 27023
CMCO
Évry, 91035
CH de Firminy
Firminy, 42704
Study site
Hagondange, 57300
CH de la région St Omer
Helfaut, 62570
Cabinet de cardiologie
Hénin-Beaumont, 62110
Cabinet de cardiologie
Lannion, 22300
Centre Hospitalier Pierre Le Damany
Lannion, 22303
Cmc Parly Ii
Le Chesnay, 78150
CH J. Monod
Le Havre, 76600
CH St Philibert
Lomme, 59462
CH de Bretagne Sud
Lorient, 56322
Ch de Bretagne Sud
Lorient
Centre Hospitalier de Sambre Avesnois
Maubeuge, 59607
Hôpital Ste Blandine
Metz, 57045
Clinique Claude Bernard
Metz, 57072
Clinique de Montargis
Montargis, 45200
Clinique Pont de Chaume
Montauban, 82000
Cabinet de Cardiologie
Narbonne, 11100
Hopital Privé A. Brillard
Nogent-sur-Marne, 94130
Hôpital Lariboisière
Paris, 75475
CH Poitiers
Poitiers
Centre hospitalier général
Roanne, 42328
Clinique Saint Hilaire
Rouen
Centre hospitalier Yves Le Fol
Saint-Brieuc, 22023
CCN
Saint-Denis, 93207
CHU - Hôpital Nord
Saint-Etienne, 42055
H.I.A. Begin
Saint-Mandé, 94160
CHG
Saint-Nazaire, 44606
CH
Soissons, 02200
CH Broussais
St-Malo
Centre Hospitalier
Tulle, 19012
Centre Hospitalier de Valence
Valence, 26953
Ch Valenciennes
Valenciennes, 59300
CH Vannes - CH Bretagne Atlantique
Vannes, 56017
Germany47 sites
Kardiologische Praxis Dr. Schröter
Alten, 17087
PRAXIS
Annaberg-Buchholz, 9300
Praxis Dr. Gerhard BÖHM
Arnstadt, 99310
Dr. med. Kai-Uwe Westermann
Aschersleben, 06449
FOWIS e. V., Förderverein für die medizinische Wissenschaft und Schulung
Berlin, 13187
Praxis Dr. Bott
Berlin
Praxis Schmidt/Engelsing
Berlin
Study site
Berlin
Innere Medizin und Kardiologie
Bünde, 32257
Praxis Dr. Gloes
Chemnitz, 09119
Praxis Dr. Med Stellmach
Chemnitz, 09126
Praxis Troeger
Chemnitz
Gesundheitszentrum Im Esc
Dresden, 01277
Praxis Engelhard Kaiser
Düsseldorf
Kardiologische Praxis
Ebersbach, 02730
FA fur Innere Medizin/Kardiologie
Eilenburg, 04838
Klinik Eilenburg
Eilenburg
Kardiologische Praxis
Eschwege, 37269
Gemeinschaftspraxis Dr. Bemmann, Dr. Sadowski, Dr. Boehme
Frankfurt, 15230
Kardiocentrum Frankfurt and der Klinik Rotes Kreuz
Frankfurt, 60316
DRK Krankenhaus Grevesmuehlen
Grevesmühlen, 23936
Baerenfaenger Dr. Petra Private Practice
Hanau, 63450
Gemeinschaftspraxis Dr. Loebe - Dr. Weissbrodt
Leipzig, 04103
FA fur Innere Medizin/Kardiologie
Leipzig, 04107
Praxis Dr. Andreas Herzfeld
Leipzig, 04209
Praxis Dr. med. Irina Boran
Leipzig
Praxis Schreiner
Leipzig
Medizin/Kardiologie/Diabetologie
Lichtentanne, 08115
Staedt. Linikum Medizinische Klinik Lueneburg
Lüneburg
SPENGLER
Machern, 04827
PRAXIS
Markkleeberg, 04416
Study site
Memmingen
Kardiologische - angiologische Praxis Dr. med. Jörg Walter
Mühlhausen, 99974
Klinikum Bogenhausen
München, 81925
Gemeinschaftspraxis Dres.Med.U. Heinrich Und Dr Predel
Nordhausen, 99734
Praxis für Gefäßmedizin
Nordhausen, 99734
Praxis Dr. Donaubauer
Oschatz
Praxis Dr. Stuehn-Pfeiffer , Dr. Wilke
Papenburg, 26871
Med. Martina Trummel Praxis Innere Medizin / Kardiologie
Quedlinburg, 06484
DRK Krankenhaus Ratzeburg
Ratzeburg
Diakonie Klinikum Schwäbisch Hall GmbH
Schwäbisch Hall, 74523
Praxis Dr. Noehring
Schwarzenberg, 08340
Praxis Prof. Frey
Starnberg, 82319
Praxis Dr. Birkenhagen
Stollberg, 09366
Sohien und Hufeland Klinikum Weimar Gmbh
Weimar, 9942
Praxis Dr Lebek
Wunsiedel, 95632
Praxis Dr. Brode
Zwickau, 08056
United States32 sites
Harishchandra N. Patel, M.D., Inc.
Anaheim, California, 92804
Narayan R. Devaraj, M.D., Inc.
Anaheim, California, 92804
Piedmont Hospital
Atlanta, Georgia, 30309
Northside Hospital Cardiology
Atlanta, Georgia
Low Country Medical Group
Beaufort, North Carolina, 29906
Lakshimi Mizin Cardiology
Carbondale, Pennsylvania, 18407
Coastal Cardiology
Charleston, South Carolina
Study site
Charleston, South Carolina
Study site
Charlotte, North Carolina, 28204
Scranton Heart Institute
Clarks Green, Pennsylvania
Columbia Cardiology Consultants
Columbia, South Carolina, 29204
East Ohio Rag Hospital
Columbus, Ohio, 43205
Easton Cardiology
Easton, Pennsylvania, 18042
St. Rose Hospital
Fremont, California, 94538
Northeast Georgia heart Center
Gainesville, Georgia, 30501
Study site
Hanford, California
Study site
Los Angeles, California
Southwest Cardiovascular Associates
Mesa, Arizona, 85205
Mountain Vista Medical Center
Mesa, Arizona, 85209-3767
Pacific Arrhythmia Services
Mesa, Arizona, 91942
Ocean Cardiology
Murrells Inlet, South Carolina
Complete Cardiology Care Live Oak Street
New Smyrna Beach, Florida
Metroform Medical Complex
Newark, Delaware, 19713
Study site
Pawleys Island, South Carolina
Study site
Peoria, Arizona
Advanced Heart and Vascular Institute
Phoenix, Arizona, 85006
Simi Valley Hospital
Simi Valley, California, 93065
The Toledo Hospital
Toledo, Ohio, 43615
Toledo Clinic Inc
Toledo, Ohio
Victoria Heart and Vascular Center
Victoria, Texas, 77901
Electrophysiology Research Foundation
Warren Township, New Jersey, 07059
Abbas Shehadeh, MD, PA
West Orange, New Jersey, 07052
Spain19 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Germans Trias i Pujol
Badalona, 08916
Hospital Marina Salud de Denia
Denia, 03700
Hospital general de Elda
Elda
H.A. Marcide
Ferrol
Hospital Galdakao
Galdakao
Cabuenes
Gijón
Hospital Universitario San Cecilio
Granada, 18012
Hospital Rafael Mendez
Lorca, 30800
Complejo Hospitalario Xeral Calde
Lugo
Hospital 12 de Octubre
Madrid, 28026
Hospital de Fuenlabrada
Madrid, 28942
CHOU
Ourense
Hospital Montecelo
Pontevedra, 36071
Virgen del Rocio
Seville
Joan XXIII
Tarragona, 43007
Hospital Clínico Universitario
Valencia, 46010
Hospital Universitario Rio Hortega
Valladolid
Hospital Lluis Alcanyis
Xàtiva, 46800
Japan12 sites
Shobara Red Cross Hospital
Hiroshima, 727-0013
Kimitsu Chuo Hospital
Kisarazu, 292-8535
Yokosuka Kyosai General Hospital
Kyosai
National Hospital Organization Oita Medical Center
Ōita, 870-0263
Sakurabashi Watanabe Hospital
Osaka, 530-0001
Tominaga Hospital
Osaka, 556-0017
Osaka National Hospital
Osaka
Okamura Memorial Hospital
Suntou-gun, 411-0904
Tokai University Tokyo Hospital
Tokyo, 151-0053
Tokyo Metropolitan Tama Medical Center
Tokyo, 183-8524
Aoyama Hospital
Toyokawa, 441-0195
Yokohama City University Hospital
Yokohama
Italy10 sites
Ospedale San Donato
Arezzo, 52100
Ospedale Civile di Conegliano
Conegliano
Arcispedale S. Maria Nuova
Florence, 50122
Ospedale Nuovo San Giovanni di Dio
Florence
Ospedale S. Maria Annunziata
Florence
AOU S.Paolo
Milan, 20142
Ospedale Valdarno
Montevarchi
Ospedale Sacrocuore - Don Calabria
Negrar
University Hospital of Pisa
Pisa, 56038
Ospedale OO.OO.San Giovanni e Ruggi d'Aragona
Salerno, 84131
Belgium8 sites
Cliniques Sud Luxembourg
Arlon, 6700
RHMS Ath - Baudour
Baudour, 7331
Hôpital Brugmann
Brussels, 1020
vzw Sint-Jozefskliniek
Izegem
AZ Groeninge
Kortrijk
UZ Gasthuisberg Leuven
Leuven, 3000
Clinique & Maternité Sainte-Elisabeth Namur
Namur, 5000
Hôpital de La Tourelle
Verviers, 4800
Canada4 sites
Hotel Dieu de Montreal
Montreal
Maisonneuve-Rosemont
Montreal
Chus-Fleurimont - Hospital
Sherbrooke
Study site
Trois-Rivières
Switzerland4 sites
Study site
Basel
Study site
Lausanne
Ospedale La Carità
Locarno, 6600
Universitaetsspital Zuerich
Zurich, 8091
About this study
Official title: AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
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.
Read the detailed description
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
- Atrial Arrhythmia
- Keywords
- Reply, Symphony, Atrial arrhythmias, V pacing, Evaluate the incidence and evolution over-time of co-morbidities
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
% ventricular pacing
as measured in the device over the timeframe period
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2015
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188356
- Sponsor's protocol ID
- RGST04-EMERALD Study
- Other IDs
- RGST04
- Acronym
- EMERALD
- Status last verified
- Mar 2019
- First submitted
- 24 Aug 2010
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
- ClinicalTrials.gov ID
- NCT01188356
- Acronym / sponsor ID
- EMERALD / RGST04-EMERALD Study
- Conditions
- Atrial Arrhythmia
- Keywords
- Reply, Symphony, Atrial arrhythmias, V pacing, Evaluate the incidence and evolution over-time of co-morbidities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,350 participants (actual)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sponsor plans the enrolment of a total of 2188 subjects in this clinical investigation.
Key inclusion criteria (1 listed)
- Patient implanted (primo-implant, replacement, upgrade) with dual chamber pacemaker from less than two months or implanted at inclusion.
Key exclusion criteria (2 listed)
- Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines
- Permanent or persistent atrial tachyarrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Atrial arrhythmias incidence
Time frame: 2 years
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
% ventricular pacing
Time frame: 2 years
as measured in the device over the timeframe period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
Related trials for Atrial Arrhythmia
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
190 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Arrhythmia, run by MicroPort CRM at 190 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 190 sites in France, Germany, United States, Spain, Japan and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial arrhythmias incidence (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.