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

March 21, 2019 updated by: MicroPort CRM

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

4350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Tugun, Queensland, Australia, 4224
        • John Flynn Private Hospital
  • Belgium
      • Arlon, Belgium, 6700
        • Cliniques Sud Luxembourg
      • Baudour, Belgium, 7331
        • RHMS Ath - Baudour
      • Brussels, Belgium, 1020
        • Hôpital Brugmann
      • Izegem, Belgium
        • vzw Sint-Jozefskliniek
      • Kortrijk, Belgium
        • AZ Groeninge
      • Leuven, Belgium, 3000
        • UZ Gasthuisberg Leuven
      • Namur, Belgium, 5000
        • Clinique & Maternité Sainte-Elisabeth Namur
      • Verviers, Belgium, 4800
        • Hôpital de La Tourelle
  • Canada
      • Montreal, Canada
        • Hotel Dieu de Montreal
      • Montreal, Canada
        • Maisonneuve-Rosemont
      • Sherbrooke, Canada
        • Chus-Fleurimont - Hospital
      • Trois-Rivieres, Canada
  • Denmark
      • Bispebjerg, Denmark
        • Bispebjerg Hospital
      • Hellerup, Denmark, 2900
        • Gentofte Hospital
  • France
      • Aix-en-Provence, France, 13611
        • Polyclinique Parc Rambot
      • Albi, France
        • CHG Albi
      • Annecy, France, 74011
        • Centre hospitalier de la région d'Annecy
      • Arras, France, 62000
        • Cabinet Medical
      • Brest, France, 29609
        • CHU Brest
      • Brive La Gaillarde, France, 19312
        • CH Brive
      • Cambrai, France
        • Clinique Ste Marie
      • Chatellerault, France, 86100
        • Clinique Bon Secours
      • Chaumont, France, 52014
        • Ch Chaumont
      • Cherbourg, France, 50102
        • CH Cherbourg
      • Châlon-en-Champagne, France, 51005
        • CH Châlon en Champagne
      • Clamart, France, 92151
        • HIA Percy
      • Dinan, France, 22100
        • CH René Pleven
      • Douarnenez, France, 29100
        • Ch Douarnenez
      • Evecquemont, France, 78740
        • Centre Cardiologique d'Evecquemont
      • Evreux, France, 27023
        • CH D'Evreux
      • Evry, France, 91035
        • CMCO
      • Firminy, France, 42704
        • CH de Firminy
      • Hagondange, France, 57300
      • Helfaut, France, 62570
        • CH de la région St Omer
      • Henin Beaumont, France, 62110
        • Cabinet de cardiologie
      • Lannion, France, 22303
        • Centre Hospitalier Pierre Le Damany
      • Lannion, France, 22300
        • Cabinet de cardiologie
      • Le Chesnay, France, 78150
        • CMC Parly II
      • Le Havre, France, 76600
        • CH J. Monod
      • Lomme, France, 59462
        • CH St Philibert
      • Lorient, France, 56322
        • CH de Bretagne Sud
      • Lorient, France
        • CH de Bretagne Sud
      • Maubeuge, France, 59607
        • Centre Hospitalier de Sambre Avesnois
      • Metz, France, 57045
        • Hôpital Ste Blandine
      • Metz, France, 57072
        • Clinique Claude Bernard
      • Montargis, France, 45200
        • Clinique de Montargis
      • Montauban, France, 82000
        • Clinique Pont de Chaume
      • Narbonne, France, 11100
        • Cabinet de cardiologie
      • Nogent Sur Marne, France, 94130
        • Hopital Privé A. Brillard
      • Paris, France, 75475
        • Hôpital Lariboisière
      • Poitiers, France
        • CH Poitiers
      • Roanne, France, 42328
        • Centre Hospitalier Général
      • Rouen, France
        • Clinique Saint Hilaire
      • Saint Brieuc, France, 22023
        • Centre hospitalier Yves Le Fol
      • Saint Denis, France, 93207
        • CCN
      • Saint Etienne, France, 42055
        • Chu - Hopital Nord
      • Saint Malo, France
        • CH Broussais
      • Saint Mande, France, 94160
        • H.I.A. Begin
      • Soissons, France, 02200
        • CH
      • St Nazaire, France, 44606
        • CHG
      • Tulle, France, 19012
        • Centre Hospitalier
      • Valence, France, 26953
        • Centre Hospitalier de Valence
      • Valenciennes, France, 59300
        • Ch Valenciennes
      • Vannes, France, 56017
        • CH Vannes - CH Bretagne Atlantique
  • Germany
      • Alten, Germany, 17087
        • Kardiologische Praxis Dr. Schröter
      • Annaberg-buchholz, Germany, 9300
        • Praxis
      • Arnstadt, Germany, 99310
        • Praxis Dr. Gerhard BÖHM
      • Aschersleben, Germany, 06449
        • Dr. med. Kai-Uwe Westermann
      • Berlin, Germany
      • Berlin, Germany, 13187
        • FOWIS e. V., Förderverein für die medizinische Wissenschaft und Schulung
      • Berlin, Germany
        • Praxis Dr. Bott
      • Berlin, Germany
        • Praxis Schmidt/Engelsing
      • Bunde, Germany, 32257
        • Innere Medizin und Kardiologie
      • Chemnitz, Germany, 09119
        • Praxis Dr. Gloes
      • Chemnitz, Germany, 09126
        • Praxis Dr. Med Stellmach
      • Chemnitz, Germany
        • Praxis Troeger
      • Dresden, Germany, 01277
        • Gesundheitszentrum Im Esc
      • Dusseldorf, Germany
        • Praxis Engelhard Kaiser
      • Ebersbach, Germany, 02730
        • Kardiologische Praxis
      • Eilenburg, Germany, 04838
        • FA fur Innere Medizin/Kardiologie
      • Eilenburg, Germany
        • Klinik Eilenburg
      • Eschwege, Germany, 37269
        • Kardiologische Praxis
      • Frankfurt, Germany, 15230
        • Gemeinschaftspraxis Dr. Bemmann, Dr. Sadowski, Dr. Boehme
      • Frankfurt, Germany, 60316
        • Kardiocentrum Frankfurt and der Klinik Rotes Kreuz
      • Grevesmuehlen, Germany, 23936
        • DRK Krankenhaus Grevesmuehlen
      • Hanau, Germany, 63450
        • Baerenfaenger Dr. Petra Private Practice
      • Leipzig, Germany, 04103
        • Gemeinschaftspraxis Dr. Loebe - Dr. Weissbrodt
      • Leipzig, Germany, 04107
        • FA fur Innere Medizin/Kardiologie
      • Leipzig, Germany, 04209
        • Praxis Dr. Andreas Herzfeld
      • Leipzig, Germany
        • Praxis Dr. med. Irina Boran
      • Leipzig, Germany
        • Praxis Schreiner
      • Lichtentanne, Germany, 08115
        • Medizin/Kardiologie/Diabetologie
      • Lueneburg, Germany
        • Staedt. Linikum Medizinische Klinik Lueneburg
      • Machern, Germany, 04827
        • SPENGLER
      • Markkleeberg, Germany, 04416
        • Praxis
      • Memmingen, Germany
      • Mühlhausen, Germany, 99974
        • Kardiologische - angiologische Praxis Dr. med. Jörg Walter
      • München, Germany, 81925
        • Klinikum Bogenhausen
      • Nordhausen, Germany, 99734
        • Gemeinschaftspraxis Dres.Med.U. Heinrich Und Dr Predel
      • Nordhausen, Germany, 99734
        • Praxis für Gefäßmedizin
      • Oschatz, Germany
        • Praxis Dr. Donaubauer
      • Papenburg, Germany, 26871
        • Praxis Dr. Stuehn-Pfeiffer , Dr. Wilke
      • Quedlinburg, Germany, 06484
        • Med. Martina Trummel Praxis Innere Medizin / Kardiologie
      • Ratzeburg, Germany
        • DRK Krankenhaus Ratzeburg
      • Schwarzenberg, Germany, 08340
        • Praxis Dr. Noehring
      • Schwäbisch Hall, Germany, 74523
        • Diakonie Klinikum Schwäbisch Hall GmbH
      • Starnberg, Germany, 82319
        • Praxis Prof. Frey
      • Stollberg, Germany, 09366
        • Praxis Dr. Birkenhagen
      • Weimar, Germany, 9942
        • Sohien und Hufeland Klinikum Weimar Gmbh
      • Wunsiedel, Germany, 95632
        • Praxis Dr Lebek
      • Zwickau, Germany, 08056
        • Praxis Dr. Brode
  • Italy
      • Arezzo, Italy, 52100
        • Ospedale San Donato
      • Conegliano, Italy
        • Ospedale Civile di Conegliano
      • Firenze, Italy
        • Ospedale S. Maria Annunziata
      • Firenze, Italy, 50122
        • Arcispedale S. Maria nuova
      • Firenze, Italy
        • Ospedale Nuovo San Giovanni di Dio
      • Milano, Italy, 20142
        • AOU S.Paolo
      • Montevarchi, Italy
        • Ospedale Valdarno
      • Negrar, Italy
        • Ospedale Sacrocuore - Don Calabria
      • Pisa, Italy, 56038
        • University Hospital of Pisa
      • Salerno, Italy, 84131
        • Ospedale OO.OO.San Giovanni e Ruggi d'Aragona
  • Japan
      • Hiroshima, Japan, 727-0013
        • Shobara Red Cross Hospital
      • Kisarazu- city, Japan, 292-8535
        • Kimitsu Chuo Hospital
      • Kyosai, Japan
        • Yokosuka Kyosai General Hospital
      • Oita City, Japan, 870-0263
        • National Hospital Organization Oita Medical Center
      • Osaka, Japan, 530-0001
        • Sakurabashi Watanabe Hospital
      • Osaka, Japan
        • Osaka National Hospital
      • Osaka-shi, Japan, 556-0017
        • Tominaga Hospital
      • Suntou-gun, Japan, 411-0904
        • Okamura memorial hospital
      • Tokyo, Japan, 151-0053
        • Tokai University Tokyo Hospital
      • Tokyo, Japan, 183-8524
        • Tokyo Metropolitan Tama Medical Center
      • Toyokawa City, Japan, 441-0195
        • Aoyama Hospital
      • Yokohama, Japan
        • Yokohama City University Hospital
  • Netherlands
      • Zutphen, Netherlands, 7207
        • Gelre Ziekenhuizen
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Denia, Spain, 03700
        • Hospital Marina Salud de Denia
      • Elda, Spain
        • Hospital General de Elda
      • Ferrol, Spain
        • H.A. Marcide
      • Galdakao, Spain
        • Hospital Galdakao
      • Gijon, Spain
        • Cabueñes
      • Granada, Spain, 18012
        • Hospital Universitario San Cecilio
      • Lorca, Spain, 30800
        • Hospital Rafael Méndez
      • Lugo, Spain
        • Complejo Hospitalario Xeral Calde
      • Madrid, Spain, 28942
        • Hospital De Fuenlabrada
      • Madrid, Spain, 28026
        • Hospital 12 de Octubre
      • Ourense, Spain
        • CHOU
      • Pontevedra, Spain, 36071
        • Hospital Montecelo
      • Sevilla, Spain
        • Virgen del Rocio
      • Tarragona, Spain, 43007
        • Joan XXIII
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario
      • Valladolid, Spain
        • Hospital Universitario Rio Hortega
      • Xativa, Spain, 46800
        • Hospital Lluis Alcanyis
  • Switzerland
      • Basel, Switzerland
      • Lausanne, Switzerland
      • Locarno, Switzerland, 6600
        • Ospedale La Carità
      • Zuerich, Switzerland, 8091
        • Universitaetsspital Zuerich
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85205
        • Southwest Cardiovascular Associates
      • Mesa, Arizona, United States, 91942
        • Pacific Arrhythmia Services
      • Mesa, Arizona, United States, 85209-3767
        • Mountain Vista Medical Center
      • Peoria, Arizona, United States
      • Phoenix, Arizona, United States, 85006
        • Advanced Heart and Vascular Institute
    • California
      • Anaheim, California, United States, 92804
        • Harishchandra N. Patel, M.D., Inc.
      • Anaheim, California, United States, 92804
        • Narayan R. Devaraj, M.D., Inc.
      • Fremont, California, United States, 94538
        • St. Rose Hospital
      • Hanford, California, United States
      • Los Angeles, California, United States
      • Simi Valley, California, United States, 93065
        • Simi Valley Hospital
    • Delaware
      • Newark, Delaware, United States, 19713
        • Metroform Medical Complex
    • Florida
      • New Smyrna Beach, Florida, United States
        • Complete Cardiology Care Live Oak Street
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States
        • Northside Hospital Cardiology
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Heart Center
    • New Jersey
      • Warren, New Jersey, United States, 07059
        • Electrophysiology Research Foundation
      • West Orange, New Jersey, United States, 07052
        • Abbas Shehadeh, MD, PA
    • North Carolina
      • Beaufort, North Carolina, United States, 29906
        • Low Country Medical Group
      • Charlotte, North Carolina, United States, 28204
    • Ohio
      • Columbus, Ohio, United States, 43205
        • East Ohio Rag Hospital
      • Toledo, Ohio, United States, 43615
        • The Toledo Hospital
      • Toledo, Ohio, United States
        • Toledo Clinic Inc
    • Pennsylvania
      • Carbondale, Pennsylvania, United States, 18407
        • Lakshimi Mizin Cardiology
      • Clarks Green, Pennsylvania, United States
        • Scranton Heart Institute
      • Easton, Pennsylvania, United States, 18042
        • Easton Cardiology
    • South Carolina
      • Charleston, South Carolina, United States
      • Charleston, South Carolina, United States
        • Coastal Cardiology
      • Columbia, South Carolina, United States, 29204
        • Columbia Cardiology Consultants
      • Murrells Inlet, South Carolina, United States
        • Ocean Cardiology
      • Pawleys Island, South Carolina, United States
    • Texas
      • Victoria, Texas, United States, 77901
        • Victoria Heart and Vascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The sponsor plans the enrolment of a total of 2188 subjects in this clinical investigation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years
% ventricular pacing
Time Frame: 2 years
as measured in the device over the timeframe period
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroPort CRM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

August 24, 2010

First Submitted That Met QC Criteria

August 24, 2010

First Posted (Estimate)

August 25, 2010

Study Record Updates

Last Update Posted (Actual)

March 25, 2019

Last Update Submitted That Met QC Criteria

March 21, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGST04-EMERALD Study
  • RGST04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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