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

This study has been completed.
Information provided by:
LivaNova Identifier:
First received: September 17, 2007
Last updated: January 9, 2015
Last verified: January 2015

Recent studies have shown the importance of preserving spontaneous atrio-ventricular conduction in patients implanted with an implantable cardiac pacemaker.

The SafeR/AAISafeR pacing mode, developed by Sorin Group/ELA Medical and available on Reply and SymphonyTM dual-chamber pacemakers, provides physiological atrial pacing while ensuring ventricular backup pacing in case of AV block in patients implanted for Sinus Dysfunction, Brady Tachy Syndrome or paroxysmal Atrio Ventricular block3 (AV block).

Memory functions (EGM episodes and Marker chains) available with the SafeR/AAISafeR pacing mode have been used until now to verify the safety of the algorithm. However, these stored EGM episodes and Marker chains may also provide precious information related to the nature of the AV block and the evolution of conduction disorders through time.

So far no studies have been carried out on this subject using the latest generation of pacemakers. This results from the unavailability of any diagnostic tool in currently marketed devices. Studies reporting the incidence of AV block in patients implanted for Sinus Dysfunction are based only on the occurrence of symptomatic AV block and/or the observation of conduction disorders on surface ECG during follow-up4,5.

The diagnostic functions available with the SafeR/AAISafeR mode enable to diagnose and record in device memory all AV blocks, regardless of the degree of the AV block and the symptom(s) of the patient. Therefore, this unique diagnostic tool could enable to determine the nature and to analyze through time the evolution of conduction disorders in patients implanted for Sinus Dysfunction, Brady Tachy Syndrome or paroxysmal Atrio Ventricular block, in order to better identify the indications for implant and to provide further appropriate pacing mode.

The observational study will enable to compile all these device memory data in order to directly assess statistical analysis of AV block incidence and evolution according to the nature of the AV block, the incidence of paroxysmal atrial arrhythmias, the anti arrhythmic drugs medication and other.

Sinus Node Dysfunction
Brady Tachy Syndroma Population

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

Resource links provided by NLM:

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)

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

Inclusion Criteria:

  • SND
  • BTS
  • Suspected paroxysmal AVB
  • Documented paroxysmal AVB

Exclusion Criteria:

  • Permanent high degree AVB
  • Contra indication to the SafeR pacing mode
  • PR higher than 350 ms
  • Life expectancy lower than 12 months
  • Inability or refusal to participate to the study
  • Not available for follow ups
  • Minors or pregnant women
  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 identifier: NCT00531037

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

Responsible Party: Borri-Brunetto, Sorin group Identifier: NCT00531037     History of Changes
Other Study ID Numbers: Nature - RGST01
Study First Received: September 17, 2007
Last Updated: January 9, 2015

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

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Pathologic Processes processed this record on May 22, 2017