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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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Scientific title
AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
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Secondary ID [1]
0
0
RGST04
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Secondary ID [2]
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0
RGST04-EMERALD Study
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Universal Trial Number (UTN)
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Trial acronym
EMERALD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Arrhythmia
0
0
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Condition category
Condition code
Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
0
0
Atrial arrhythmias incidence
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Assessment method [1]
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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
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Timepoint [1]
0
0
2 years
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Primary outcome [2]
0
0
% ventricular pacing
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Assessment method [2]
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0
as measured in the device over the timeframe period
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Timepoint [2]
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0
2 years
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Eligibility
Key inclusion criteria
- Patient implanted (primo-implant, replacement, upgrade) with dual chamber pacemaker from less than two months or implanted at inclusion.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines
* Permanent or persistent atrial tachyarrhythmia
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/08/2017
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Sample size
Target
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Accrual to date
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Final
4350
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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John Flynn Private Hospital - Tugun
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Recruitment postcode(s) [1]
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4224 - Tugun
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Funding & Sponsors
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Commercial sector/industry
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Name
MicroPort CRM
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01188356
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Contacts
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01188356
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