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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Sorin Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT01188356
First received: August 24, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted

August 24, 2010
August 24, 2010
March 2010
Not Provided
Atrial arrhythmias incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
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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 through a 2 years follow-up.

The study will particularly focus on the number of patients moving to persistent Atrial Fibrillation as a function of pacing mode, pacing sites, and cumulative %Ap & %Vp, in a general dual-chamber pacemaker population through a 2 year follow-up.

Sub-analyses will be performed stratifying patients per medical history (etiology, co-morbidities, medical therapy, reasons of implant, primo-implant/replacement.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

The sponsor plans the enrolment of a total of 2188 subjects in this clinical investigation.

Atrial Arrhythmia
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2188
March 2012
Not Provided

Inclusion Criteria:

  • Patient implanted (primo-implant, replacement, upgrade) with one of the devices listed in § 2.2 from less than two months.
  • Patient has signed the consent to data treatment (according to the laws and regulations of the country in which the observation is performed)

Exclusion Criteria:

  1. Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines
  2. Permanent or persistent atrial tachyarrhythmia
  3. Already included in another interventional clinical study
  4. Life expectancy less than 24 months
  5. Not available for routine follow-up visits.
  6. Inability to understand the purpose of the study or refusal to cooperate
  7. Under guardianship
  8. Age of less than 18 years
  9. Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)
Both
18 Years and older
No
Contact: Alberto Borri +39 0161487211 alberto.borri.brunetto@sorin.com
United States,   France,   Germany,   Italy
 
NCT01188356
RGST04-EMERALD Study, RGST04
No
Dr. Maria Grazia BONGIORNI, Division of Cardiology University Hospital of Pisa Pisa - ITALY
Sorin Group
Not Provided
Not Provided
Sorin Group
August 2010

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