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Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers (NATURE)

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ClinicalTrials.gov Identifier: NCT00531037
Recruitment Status : Completed
First Posted : September 18, 2007
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
LivaNova

Brief Summary:
Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.

Condition or disease
Patients Implanted With a Pacemaker

Study Type : Observational
Actual Enrollment : 1440 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers
Study Start Date : June 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011



Primary Outcome Measures :
  1. High degree AV blocks [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient primo-implanted with a pacemaker (Symphony ™ DR2550, Symphony ™ D 2450, Reply DR, Reply D or any similar or higher range) device less than three months ago, programmed in SafeR mode.
Criteria

Inclusion Criteria:

  • Sinus Node Disease
  • Brady-Tachy Syndrome
  • Suspected or documented paroxysmal AVB

Exclusion Criteria:

  • Permanent high degree AVB
  • Contra indication to the SafeR pacing mode
  • PR higher than 350 ms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531037


  Show 129 Study Locations
Sponsors and Collaborators
LivaNova
Investigators
Principal Investigator: DEHARO Jean Claude, MD CHU la Timone - Marseille

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT00531037     History of Changes
Other Study ID Numbers: Nature - RGST01
RGST01
First Posted: September 18, 2007    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by LivaNova:
AV block, SND, BTS, AAIsafeR, SafeR, PM implanted