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

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

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
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 Sorin Group:

Primary Outcome Measures:
  • 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


Enrollment: 4350
Study Start Date: March 2010
Estimated Study Completion Date: January 2019
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01188356

  Show 190 Study Locations
Sponsors and Collaborators
Sorin Group
  More Information

No publications provided

Responsible Party: Sorin Group
ClinicalTrials.gov Identifier: NCT01188356     History of Changes
Other Study ID Numbers: RGST04-EMERALD Study, RGST04
Study First Received: August 24, 2010
Last Updated: June 1, 2015
Health Authority: Italy: Ethics Committee
Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on September 01, 2015