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

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ClinicalTrials.gov Identifier: NCT01188356
Recruitment Status : Active, not recruiting
First Posted : August 25, 2010
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Atrial Arrhythmia

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 Design

Study Type : Observational
Actual Enrollment : 4350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
Study Start Date : March 2010
Primary Completion Date : April 2015
Estimated Study Completion Date : August 2018
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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

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


Eligibility Criteria

Information from the National Library of Medicine

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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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188356


  Show 190 Study Locations
Sponsors and Collaborators
LivaNova
More Information

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT01188356     History of Changes
Other Study ID Numbers: RGST04-EMERALD Study
RGST04
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: November 2016

Keywords provided by LivaNova:
Reply
Symphony
Atrial arrhythmias
V pacing
Evaluate the incidence and evolution over-time of co-morbidities