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

September 17, 2007
June 15, 2010
June 2007
December 2011   (final data collection date for primary outcome measure)
High degree AV blocks [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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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

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Sinus Node Dysfunction
  • Brady Tachy Syndroma Population
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1440
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Portugal,   Spain
 
NCT00531037
Nature - RGST01, RGST01
No
Borri-Brunetto, Sorin group
Sorin Group
Not Provided
Principal Investigator: DEHARO Jean Claude, MD CHU la Timone - Marseille
Sorin Group
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP