Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
LivaNova Identifier:
First received: August 24, 2010
Last updated: November 29, 2016
Last verified: November 2016
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.

Atrial Arrhythmia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients

Further study details as provided by LivaNova:

Primary Outcome Measures:
  • 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

  • % ventricular pacing [ Time Frame: 2 years ]
    as measured in the device over the timeframe period

Enrollment: 4350
Study Start Date: March 2010
Estimated Study Completion Date: August 2018
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The sponsor plans the enrolment of a total of 2188 subjects in this clinical investigation.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01188356

  Show 190 Study Locations
Sponsors and Collaborators
  More Information

Responsible Party: LivaNova Identifier: NCT01188356     History of Changes
Other Study ID Numbers: RGST04-EMERALD Study
Study First Received: August 24, 2010
Last Updated: November 29, 2016

Keywords provided by LivaNova:
Atrial arrhythmias
V pacing
Evaluate the incidence and evolution over-time of co-morbidities processed this record on May 22, 2017