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
  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 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

Resource links provided by NLM:


Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • Atrial arrhythmias incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2188
Study Start Date: March 2010
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  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 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)
  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

Contacts
Contact: Alberto Borri +39 0161487211 alberto.borri.brunetto@sorin.com

  Show 191 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 4, 2014
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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014