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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
LivaNova
ClinicalTrials.gov Identifier:
NCT01188356
First received: August 24, 2010
Last updated: June 1, 2015
Last verified: June 2015

August 24, 2010
June 1, 2015
March 2010
April 2015   (final data collection date for primary outcome measure)
  • Atrial arrhythmias incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    as measured in the device over the timeframe period
Atrial arrhythmias incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01188356 on ClinicalTrials.gov Archive Site
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EMERALD - AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients
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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
The sponsor plans the enrolment of a total of 2188 subjects in this clinical investigation.
Atrial Arrhythmia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4350
January 2019
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Japan,   Netherlands,   Spain,   Switzerland
 
NCT01188356
RGST04-EMERALD Study, RGST04
No
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LivaNova
LivaNova
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Not Provided
LivaNova
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP