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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01188356
Acronym
EMERALD
Enrollment
4350
Registered
2010-08-25
Start date
2010-03-31
Completion date
2017-08-31
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Arrhythmia

Keywords

Reply, Symphony, Atrial arrhythmias, V pacing, Evaluate the incidence and evolution over-time of co-morbidities

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.

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).

Interventions

None listed

Sponsors

MicroPort CRM
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Atrial arrhythmias incidence2 yearsTwo 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 pacing2 yearsas measured in the device over the timeframe period

Countries

Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, Switzerland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026