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

MicroPort

Status: Completed

Conditions: Atrial Arrhythmia

Study type: Observational

Funder types: Industry

Identifiers

NCT01188356

RGST04

RGST04-EMERALD Study

Details and patient eligibility

About

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.

Full 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).

Enrollment: 4,350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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