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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
September 17, 2007
September 18, 2007
November 14, 2017
June 2007
December 2011   (Final data collection date for primary outcome measure)
High degree AV blocks [ Time Frame: 2 years ]
Not Provided
Complete list of historical versions of study NCT00531037 on ClinicalTrials.gov Archive Site
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Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers
Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers
Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Patients Implanted With a Pacemaker
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1440
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Portugal,   Spain,   United States
 
 
NCT00531037
Nature - RGST01
RGST01
No
Not Provided
Not Provided
LivaNova
LivaNova
Not Provided
Principal Investigator: DEHARO Jean Claude, MD CHU la Timone - Marseille
LivaNova
November 2017