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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients|
- Atrial arrhythmias incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]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
- % ventricular pacing [ Time Frame: 2 years ] [ Designated as safety issue: No ]as measured in the device over the timeframe period
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||January 2019|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188356
Show 190 Study Locations