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Trial record 47 of 62 for:    "Sick Sinus Syndrome"

Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR Mode (PRECISE)

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ClinicalTrials.gov Identifier: NCT02586480
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
LivaNova

Brief Summary:
Observational study on long PR interval using the SafeR mode in bradycardia patients.

Condition or disease Intervention/treatment
Sinus Node Dysfunction Atrioventricular Block Device: dual chamber pacemaker with SafeR algorithm

Detailed Description:
This observational trial aims to study the evolution of the PR interval in patients implanted with a dual chamber pacemaker with the SafeR mode. The investigators will assess the prevalence and the incidence of PR lengthening and the investigators will study the long PR interval management by physicians, depending on the data embedded in the pacemaker.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 848 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Evolution of the PR Interval in Patients Implanted With a Dual Chamber Pacemaker With Algorithm for Spontaneous AV Conduction Preservation
Study Start Date : April 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: dual chamber pacemaker with SafeR algorithm
    SafeR is an AVB management algorithm: it provides AAI pacing while continuously monitoring AV conduction, it switches to DDD when detecting AVB I, II or III, according to the following criteria: (1) AVB I: 6 long PR intervals, (2) AVB II: 3 blocked atrial events/12 cycles, (3) AVB III: 2 consecutive blocked atrial events. It switches back to AAI mode when needed.
    Other Name: Reply DR (Sorin Devices)


Primary Outcome Measures :
  1. Prolonged PR interval (> 200ms) in patients without AVB I at baseline (Incidence of "clinical" AVB1) [ Time Frame: at 12 months ]
    This incidence will be measured using PR/AR histograms stored in the device memory



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Bradycardia patients eligible for dual chamber pacemaker implantation for SND, AVBI or AVBII
Criteria

Inclusion Criteria:

  • Patient implanted (primo-implant, replacement, upgrade) with a Sorin Group™ dual chamber pacemaker according to current available guidelines and IFU from less than three months.
  • Since implantation, the device is programmed in SafeR mode
  • Patient agreed to participate, after having received the appropriate and mandatory information

Exclusion Criteria:

  • Patient contraindicated for cardiac pacing, according to current available guidelines
  • Permanent atrial fibrillation
  • Permanent high-degree AV block
  • Patient not available for routine follow-up visits
  • Patient already included in another clinical study
  • Inability to understand the purpose of the study / refusal to cooperate
  • minor age
  • Pregnancy
  • Life expectancy less than 12 months
  • Under guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02586480


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Sponsors and Collaborators
LivaNova
Investigators
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Principal Investigator: Jérôme TAIEB, MD CH du Pays d'Aix - Aix en Provence

Additional Information:

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Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT02586480     History of Changes
Other Study ID Numbers: RBSY02
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

Keywords provided by LivaNova:
bradycardia

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