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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00531037
First Posted: September 18, 2007
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LivaNova
  Purpose
Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.

Condition
Patients Implanted With a Pacemaker

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers

Further study details as provided by LivaNova:

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

Enrollment: 1440
Study Start Date: June 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT00531037     History of Changes
Other Study ID Numbers: Nature - RGST01
RGST01
First Submitted: September 17, 2007
First Posted: September 18, 2007
Last Update Posted: November 14, 2017
Last Verified: November 2017

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