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Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers (NATURE)
This study is currently recruiting participants.
Verified by Sorin Group, November 2007
Sponsors and Collaborators: Sorin Group
Sorin Group France SAS
Information provided by: Sorin Group
ClinicalTrials.gov Identifier: NCT00531037
  Purpose

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.


Condition
Measure the Incidence of High Degree AV Block in the Sinus Node Dysfunction and Brady Tachy Syndroma Population

Genetics Home Reference related topics: Brugada syndrome short QT syndrome
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers

Further study details as provided by Sorin Group:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 70
Study Start Date: June 2007
Estimated Study Completion Date: June 2009
  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531037

Contacts
Contact: Rousseauplasse Anne, PhD 33 1 46 01 30 82 anne.rousseauplasse@sorin.com

Locations
France
CH Albi Recruiting
Albi, France
Sub-Investigator: Galley Daniel, MD            
Sponsors and Collaborators
Sorin Group
Sorin Group France SAS
Investigators
Principal Investigator: DEHARO Jean Claude, MD CHU la Timone - Marseille
  More Information

Study ID Numbers: Nature - RGST01, RGST01
Study First Received: September 17, 2007
Last Updated: November 19, 2007
ClinicalTrials.gov Identifier: NCT00531037  
Health Authority: France: Ordre National des Médecins - Conseil National de l'Ordre

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

Study placed in the following topic categories:
Heart Diseases
Heart Block
Arrhythmia, Sinus
Atrioventricular Block
Sick Sinus Syndrome
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009