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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sorin Group
Sponsor:
Information provided by (Responsible Party):
Sorin Group
ClinicalTrials.gov Identifier:
NCT01188356
First received: August 24, 2010
Last updated: June 4, 2014
Last verified: June 2014

August 24, 2010
June 4, 2014
March 2010
January 2019   (final data collection date for primary outcome measure)
Atrial arrhythmias incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01188356 on ClinicalTrials.gov Archive Site
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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
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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.
 
Recruiting
2188
January 2020
January 2019   (final data collection date for primary outcome measure)

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,   Australia,   Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Japan,   Netherlands,   Spain,   Switzerland
 
NCT01188356
RGST04-EMERALD Study, RGST04
No
Sorin Group
Sorin Group
Not Provided
Not Provided
Sorin Group
June 2014

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