Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01188356




Registration number
NCT01188356
Ethics application status
Date submitted
24/08/2010
Date registered
25/08/2010
Date last updated
25/03/2019

Titles & IDs
Public title
EMERALD - AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
Scientific title
AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
Secondary ID [1] 0 0
RGST04
Secondary ID [2] 0 0
RGST04-EMERALD Study
Universal Trial Number (UTN)
Trial acronym
EMERALD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Arrhythmia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Atrial arrhythmias incidence
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
% ventricular pacing
Timepoint [2] 0 0
2 years

Eligibility
Key inclusion criteria
- Patient implanted (primo-implant, replacement, upgrade) with dual chamber pacemaker from
less than two months or implanted at inclusion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines

- Permanent or persistent atrial tachyarrhythmia

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2017
Sample size
Target
Accrual to date
Final
4350
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
John Flynn Private Hospital - Tugun
Recruitment postcode(s) [1] 0 0
4224 - Tugun
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Belgium
State/province [12] 0 0
Arlon
Country [13] 0 0
Belgium
State/province [13] 0 0
Baudour
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussels
Country [15] 0 0
Belgium
State/province [15] 0 0
Izegem
Country [16] 0 0
Belgium
State/province [16] 0 0
Kortrijk
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
State/province [18] 0 0
Namur
Country [19] 0 0
Belgium
State/province [19] 0 0
Verviers
Country [20] 0 0
Canada
State/province [20] 0 0
Montreal
Country [21] 0 0
Canada
State/province [21] 0 0
Sherbrooke
Country [22] 0 0
Canada
State/province [22] 0 0
Trois-Rivieres
Country [23] 0 0
Denmark
State/province [23] 0 0
Bispebjerg
Country [24] 0 0
Denmark
State/province [24] 0 0
Hellerup
Country [25] 0 0
France
State/province [25] 0 0
Aix-en-Provence
Country [26] 0 0
France
State/province [26] 0 0
Albi
Country [27] 0 0
France
State/province [27] 0 0
Annecy
Country [28] 0 0
France
State/province [28] 0 0
Arras
Country [29] 0 0
France
State/province [29] 0 0
Brest
Country [30] 0 0
France
State/province [30] 0 0
Brive La Gaillarde
Country [31] 0 0
France
State/province [31] 0 0
Cambrai
Country [32] 0 0
France
State/province [32] 0 0
Chatellerault
Country [33] 0 0
France
State/province [33] 0 0
Chaumont
Country [34] 0 0
France
State/province [34] 0 0
Cherbourg
Country [35] 0 0
France
State/province [35] 0 0
Châlon-en-Champagne
Country [36] 0 0
France
State/province [36] 0 0
Clamart
Country [37] 0 0
France
State/province [37] 0 0
Dinan
Country [38] 0 0
France
State/province [38] 0 0
Douarnenez
Country [39] 0 0
France
State/province [39] 0 0
Evecquemont
Country [40] 0 0
France
State/province [40] 0 0
Evreux
Country [41] 0 0
France
State/province [41] 0 0
Evry
Country [42] 0 0
France
State/province [42] 0 0
Firminy
Country [43] 0 0
France
State/province [43] 0 0
Hagondange
Country [44] 0 0
France
State/province [44] 0 0
Helfaut
Country [45] 0 0
France
State/province [45] 0 0
Henin Beaumont
Country [46] 0 0
France
State/province [46] 0 0
Lannion
Country [47] 0 0
France
State/province [47] 0 0
Le Chesnay
Country [48] 0 0
France
State/province [48] 0 0
Le Havre
Country [49] 0 0
France
State/province [49] 0 0
Lomme
Country [50] 0 0
France
State/province [50] 0 0
Lorient
Country [51] 0 0
France
State/province [51] 0 0
Maubeuge
Country [52] 0 0
France
State/province [52] 0 0
Metz
Country [53] 0 0
France
State/province [53] 0 0
Montargis
Country [54] 0 0
France
State/province [54] 0 0
Montauban
Country [55] 0 0
France
State/province [55] 0 0
Narbonne
Country [56] 0 0
France
State/province [56] 0 0
Nogent Sur Marne
Country [57] 0 0
France
State/province [57] 0 0
Paris
Country [58] 0 0
France
State/province [58] 0 0
Poitiers
Country [59] 0 0
France
State/province [59] 0 0
Roanne
Country [60] 0 0
France
State/province [60] 0 0
Rouen
Country [61] 0 0
France
State/province [61] 0 0
Saint Brieuc
Country [62] 0 0
France
State/province [62] 0 0
Saint Denis
Country [63] 0 0
France
State/province [63] 0 0
Saint Etienne
Country [64] 0 0
France
State/province [64] 0 0
Saint Malo
Country [65] 0 0
France
State/province [65] 0 0
Saint Mande
Country [66] 0 0
France
State/province [66] 0 0
Soissons
Country [67] 0 0
France
State/province [67] 0 0
St Nazaire
Country [68] 0 0
France
State/province [68] 0 0
Tulle
Country [69] 0 0
France
State/province [69] 0 0
Valence
Country [70] 0 0
France
State/province [70] 0 0
Valenciennes
Country [71] 0 0
France
State/province [71] 0 0
Vannes
Country [72] 0 0
Germany
State/province [72] 0 0
Alten
Country [73] 0 0
Germany
State/province [73] 0 0
Annaberg-buchholz
Country [74] 0 0
Germany
State/province [74] 0 0
Arnstadt
Country [75] 0 0
Germany
State/province [75] 0 0
Aschersleben
Country [76] 0 0
Germany
State/province [76] 0 0
Berlin
Country [77] 0 0
Germany
State/province [77] 0 0
Bunde
Country [78] 0 0
Germany
State/province [78] 0 0
Chemnitz
Country [79] 0 0
Germany
State/province [79] 0 0
Dresden
Country [80] 0 0
Germany
State/province [80] 0 0
Dusseldorf
Country [81] 0 0
Germany
State/province [81] 0 0
Ebersbach
Country [82] 0 0
Germany
State/province [82] 0 0
Eilenburg
Country [83] 0 0
Germany
State/province [83] 0 0
Eschwege
Country [84] 0 0
Germany
State/province [84] 0 0
Frankfurt
Country [85] 0 0
Germany
State/province [85] 0 0
Grevesmuehlen
Country [86] 0 0
Germany
State/province [86] 0 0
Hanau
Country [87] 0 0
Germany
State/province [87] 0 0
Leipzig
Country [88] 0 0
Germany
State/province [88] 0 0
Lichtentanne
Country [89] 0 0
Germany
State/province [89] 0 0
Lueneburg
Country [90] 0 0
Germany
State/province [90] 0 0
Machern
Country [91] 0 0
Germany
State/province [91] 0 0
Markkleeberg
Country [92] 0 0
Germany
State/province [92] 0 0
Memmingen
Country [93] 0 0
Germany
State/province [93] 0 0
Mühlhausen
Country [94] 0 0
Germany
State/province [94] 0 0
München
Country [95] 0 0
Germany
State/province [95] 0 0
Nordhausen
Country [96] 0 0
Germany
State/province [96] 0 0
Oschatz
Country [97] 0 0
Germany
State/province [97] 0 0
Papenburg
Country [98] 0 0
Germany
State/province [98] 0 0
Quedlinburg
Country [99] 0 0
Germany
State/province [99] 0 0
Ratzeburg
Country [100] 0 0
Germany
State/province [100] 0 0
Schwarzenberg
Country [101] 0 0
Germany
State/province [101] 0 0
Schwäbisch Hall
Country [102] 0 0
Germany
State/province [102] 0 0
Starnberg
Country [103] 0 0
Germany
State/province [103] 0 0
Stollberg
Country [104] 0 0
Germany
State/province [104] 0 0
Weimar
Country [105] 0 0
Germany
State/province [105] 0 0
Wunsiedel
Country [106] 0 0
Germany
State/province [106] 0 0
Zwickau
Country [107] 0 0
Italy
State/province [107] 0 0
Arezzo
Country [108] 0 0
Italy
State/province [108] 0 0
Conegliano
Country [109] 0 0
Italy
State/province [109] 0 0
Firenze
Country [110] 0 0
Italy
State/province [110] 0 0
Milano
Country [111] 0 0
Italy
State/province [111] 0 0
Montevarchi
Country [112] 0 0
Italy
State/province [112] 0 0
Negrar
Country [113] 0 0
Italy
State/province [113] 0 0
Pisa
Country [114] 0 0
Italy
State/province [114] 0 0
Salerno
Country [115] 0 0
Japan
State/province [115] 0 0
Hiroshima
Country [116] 0 0
Japan
State/province [116] 0 0
Kisarazu- city
Country [117] 0 0
Japan
State/province [117] 0 0
Kyosai
Country [118] 0 0
Japan
State/province [118] 0 0
Oita City
Country [119] 0 0
Japan
State/province [119] 0 0
Osaka-shi
Country [120] 0 0
Japan
State/province [120] 0 0
Osaka
Country [121] 0 0
Japan
State/province [121] 0 0
Suntou-gun
Country [122] 0 0
Japan
State/province [122] 0 0
Tokyo
Country [123] 0 0
Japan
State/province [123] 0 0
Toyokawa City
Country [124] 0 0
Japan
State/province [124] 0 0
Yokohama
Country [125] 0 0
Netherlands
State/province [125] 0 0
Zutphen
Country [126] 0 0
Spain
State/province [126] 0 0
Alicante
Country [127] 0 0
Spain
State/province [127] 0 0
Badalona
Country [128] 0 0
Spain
State/province [128] 0 0
Denia
Country [129] 0 0
Spain
State/province [129] 0 0
Elda
Country [130] 0 0
Spain
State/province [130] 0 0
Ferrol
Country [131] 0 0
Spain
State/province [131] 0 0
Galdakao
Country [132] 0 0
Spain
State/province [132] 0 0
Gijon
Country [133] 0 0
Spain
State/province [133] 0 0
Granada
Country [134] 0 0
Spain
State/province [134] 0 0
Lorca
Country [135] 0 0
Spain
State/province [135] 0 0
Lugo
Country [136] 0 0
Spain
State/province [136] 0 0
Madrid
Country [137] 0 0
Spain
State/province [137] 0 0
Ourense
Country [138] 0 0
Spain
State/province [138] 0 0
Pontevedra
Country [139] 0 0
Spain
State/province [139] 0 0
Sevilla
Country [140] 0 0
Spain
State/province [140] 0 0
Tarragona
Country [141] 0 0
Spain
State/province [141] 0 0
Valencia
Country [142] 0 0
Spain
State/province [142] 0 0
Valladolid
Country [143] 0 0
Spain
State/province [143] 0 0
Xativa
Country [144] 0 0
Switzerland
State/province [144] 0 0
Basel
Country [145] 0 0
Switzerland
State/province [145] 0 0
Lausanne
Country [146] 0 0
Switzerland
State/province [146] 0 0
Locarno
Country [147] 0 0
Switzerland
State/province [147] 0 0
Zuerich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MicroPort CRM
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01188356
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01188356