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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Sorin Group.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT00531037
First received: September 17, 2007
Last updated: June 15, 2010
Last verified: June 2010
  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
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 Sorin Group:

Primary Outcome Measures:
  • High degree AV blocks [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 1440
Study Start Date: June 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  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
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 ClinicalTrials.gov identifier: NCT00531037

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

No publications provided

Responsible Party: Borri-Brunetto, Sorin group
ClinicalTrials.gov Identifier: NCT00531037     History of Changes
Other Study ID Numbers: Nature - RGST01, RGST01
Study First Received: September 17, 2007
Last Updated: June 15, 2010
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Germany: Ethics Commission
Italy: Ethics Committee
Spain: Ethics Committee

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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Sick Sinus Syndrome
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block

ClinicalTrials.gov processed this record on August 28, 2014