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Completed

NCT Number: NCT01188356

EMERALD - 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.

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Key information

Conditions

Atrial Arrhythmia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

John Flynn Private Hospital, Tugun, Queensland, Australia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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. % ventricular pacing

    Time frame: 2 years

    as measured in the device over the timeframe period

Sponsors and collaborators

Lead sponsor

MicroPort CRM

Industry

Registry information

Official study title

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

Acronym: EMERALD

Important dates

Study start
2010
Primary completion
2015
Study completion
2017
First posted
Aug 25, 2010
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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