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

Sponsor
LivaNova (Industry)
Overall Status
Completed
CT.gov ID
NCT02586480
Collaborator
(none)
848
Enrollment
58
Locations
44
Duration (Months)
14.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
848 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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 :
Apr 1, 2012
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Outcome Measures

Primary Outcome Measures

  1. Prolonged PR interval (> 200ms) in patients without AVB I at baseline (Incidence of "clinical" AVB1) [at 12 months]

    This incidence will be measured using PR/AR histograms stored in the device memory

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CH Basse Terre Terre Basse Guadeloupe France
2 CH du Pays d'Aix Aix-en-Provence France
3 CH Alençon Alençon France
4 Cabinet Alès Alès France
5 hôpital Sud Amiens France
6 CH Annecy Annecy France
7 hôpital privé Antony Antony France
8 hôpital d'Argenteuil Argenteuil France
9 hôpital St André Bordeaux France
10 CH Bourges Bourges France
11 CHU Brest Brest France
12 Clinique Keraudren Brest France
13 CHU Caen Caen France
14 Clinique des 2 Caps Calais France
15 CH Chartres Chartres France
16 Ch Chaumont Chaumont France
17 Cabinet Cherbourg Cherbourg France
18 HIA Percy Clamart France
19 Hôpital L. Pasteur Colmar France
20 CH Corbeil Essonnes Corbeil Essonnes France
21 Cabinet Creutzwald Creutzwald France
22 Hopital Henri Mondor Créteil France
23 CH Dinan Dinan France
24 CH Douarnenez Douarnenez France
25 CH Evreux Evreux France
26 CMCO Evry Evry France
27 Cabinet Forbach Forbach France
28 CH Forbach Forbach France
29 CH Haguenau Haguenau France
30 CH Helfaut Helfaut France
31 CH Lannion Lannion France
32 CH Le Havre Le Havre France
33 CMCM Le Mans Le Mans France
34 CMC Port Marly Le Port-Marly France
35 CH Lomme Lomme France
36 CH Lorient Lorient France
37 CHU La Timone Marseille France
38 Hôpital Nord Marseille France
39 Clinique Melun Melun France
40 CH Privé Metz Metz France
41 CH Montfermeil Montfermeil France
42 Clinique Montpellier Montpellier France
43 Clinique A. Paré Nancy France
44 NCN Nantes Nantes France
45 CH Orléans Orléans France
46 Cabinet Paris Paris France
47 CH St Joseph Paris France
48 CH Poissy St Germain Poissy France
49 CHU Poitiers Poitiers France
50 Clinique St Hilaire Rouen France
51 CCN St Denis Saint Denis France
52 CH St Nazaire Saint Nazaire France
53 CH Sens Sens France
54 CH St Malo St Malo France
55 CH Thionville Thionville France
56 CH Valenciennes Valenciennes France
57 Cabinet Valognes Valognes France
58 CH Villefrance Villefranche Sur Saone France

Sponsors and Collaborators

  • LivaNova

Investigators

  • Principal Investigator: Jérôme TAIEB, MD, CH du Pays d'Aix - Aix en Provence

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
LivaNova
ClinicalTrials.gov Identifier:
NCT02586480
Other Study ID Numbers:
  • RBSY02
First Posted:
Oct 26, 2015
Last Update Posted:
Oct 18, 2017
Last Verified:
Oct 1, 2017
Keywords provided by LivaNova
bradycardia
Additional relevant MeSH terms:
Atrioventricular Block
Sick Sinus Syndrome

Study Results

No Results Posted as of Oct 18, 2017