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

October 16, 2017 updated by: LivaNova

Evolution of the PR Interval in Patients Implanted With a Dual Chamber Pacemaker With Algorithm for Spontaneous AV Conduction Preservation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
848

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-en-Provence, France
        • CH du Pays D'Aix
      • Alençon, France
        • CH Alençon
      • Alès, France
        • Cabinet Alès
      • Amiens, France
        • Hopital Sud
      • Annecy, France
        • CH Annecy
      • Antony, France
        • Hôpital Privé Antony
      • Argenteuil, France
        • Hopital d'Argenteuil
      • Bordeaux, France
        • Hôpital St André
      • Bourges, France
        • CH Bourges
      • Brest, France
        • CHU Brest
      • Brest, France
        • Clinique KERAUDREN
      • Caen, France
        • CHU Caen
      • Calais, France
        • Clinique Des 2 Caps
      • Chartres, France
        • CH Chartres
      • Chaumont, France
        • Ch Chaumont
      • Cherbourg, France
        • Cabinet Cherbourg
      • Clamart, France
        • HIA Percy
      • Colmar, France
        • Hôpital L. Pasteur
      • Corbeil Essonnes, France
        • CH Corbeil Essonnes
      • Creutzwald, France
        • Cabinet Creutzwald
      • Créteil, France
        • Hopital Henri Mondor
      • Dinan, France
        • CH DINAN
      • Douarnenez, France
        • Ch Douarnenez
      • Evreux, France
        • CH Evreux
      • Evry, France
        • CMCO Evry
      • Forbach, France
        • Cabinet Forbach
      • Forbach, France
        • Ch Forbach
      • Haguenau, France
        • CH Haguenau
      • Helfaut, France
        • CH Helfaut
      • Lannion, France
        • Ch Lannion
      • Le Havre, France
        • CH Le Havre
      • Le Mans, France
        • CMCM Le Mans
      • Le Port-Marly, France
        • CMC Port Marly
      • Lomme, France
        • CH Lomme
      • Lorient, France
        • CH Lorient
      • Marseille, France
        • CHU La Timone
      • Marseille, France
        • Hôpital Nord
      • Melun, France
        • Clinique Melun
      • Metz, France
        • CH Privé Metz
      • Montfermeil, France
        • Ch Montfermeil
      • Montpellier, France
        • Clinique Montpellier
      • Nancy, France
        • Clinique A. Paré
      • Nantes, France
        • NCN Nantes
      • Orléans, France
        • CH Orléans
      • Paris, France
        • Cabinet Paris
      • Paris, France
        • CH St Joseph
      • Poissy, France
        • CH Poissy st Germain
      • Poitiers, France
        • CHU Poitiers
      • Rouen, France
        • Clinique St Hilaire
      • Saint Denis, France
        • CCN St Denis
      • Saint Nazaire, France
        • CH St Nazaire
      • Sens, France
        • CH Sens
      • St Malo, France
        • CH St Malo
      • Thionville, France
        • CH Thionville
      • Valenciennes, France
        • CH Valenciennes
      • Valognes, France
        • Cabinet Valognes
      • Villefranche Sur Saone, France
        • CH Villefrance
    • Guadeloupe
      • Terre Basse, Guadeloupe, France
        • CH Basse Terre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Bradycardia patients eligible for dual chamber pacemaker implantation for SND, AVBI or AVBII

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LivaNova

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jérôme TAIEB, MD, CH du Pays d'Aix - Aix en Provence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RBSY02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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