This trial is active, not recruiting.

Condition atrial arrhythmia
Sponsor LivaNova
Start date March 2010
End date April 2015
Trial size 4350 participants
Trial identifier NCT01188356, RGST04, RGST04-EMERALD Study


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Atrial arrhythmias incidence
time frame: 2 years
% ventricular pacing
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by LivaNova.