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

Completed

• Conditions: Atrial Arrhythmia

• Registration Number: NCT01188356
• Lead Sponsor: MicroPort CRM

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).

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-24
• Study First Posted: 2010-08-25
• Primary Completion: 2015-04
• Study Completion: 2017-08-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Atrial arrhythmias incidence	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
% ventricular pacing	2 years	as measured in the device over the timeframe period

Trial Locations

Locations (174)

Southwest Cardiovascular Associates; 🇺🇸 Mesa, Arizona, United States

Mountain Vista Medical Center; 🇺🇸 Mesa, Arizona, United States

Pacific Arrhythmia Services; 🇺🇸 Mesa, Arizona, United States

Advanced Heart and Vascular Institute; 🇺🇸 Phoenix, Arizona, United States

Harishchandra N. Patel, M.D., Inc.; 🇺🇸 Anaheim, California, United States

Narayan R. Devaraj, M.D., Inc.; 🇺🇸 Anaheim, California, United States

St. Rose Hospital; 🇺🇸 Fremont, California, United States

Simi Valley Hospital; 🇺🇸 Simi Valley, California, United States

Metroform Medical Complex; 🇺🇸 Newark, Delaware, United States

Complete Cardiology Care Live Oak Street; 🇺🇸 New Smyrna Beach, Florida, United States

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