NCT02175797

Brief Summary

The purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

June 4, 2014

Last Update Submit

April 19, 2019

Conditions

Bradycardia

Keywords

Pacemaker, leads and MRI exam

Outcome Measures

Primary Outcomes (1)

  • Measure the atrial and ventricular pacing thresholds in Volts before and after the MRI exam, using the programmer.

    1 month

Study Arms (1)

Pacemaker + leads

OTHER

all patients must have a MRI exam after pacemaker implantation

Device: MRI

Interventions

MRIDEVICE

at least 6 weeks after the implantation of the pacemaker a MRI exam is performed

Pacemaker + leads

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who is already implanted with following system KORA 100 (SR or DR) pacemaker and Beflex RF45D and/or RF46D pacing leads in the left or right pectoral region
  • Patient who is able and willing out-of-chest non medical indicated MRI scanning OR patients with planned medical indicated out of chest MRI scanning
  • Patient who fulfils MRI solutions conditions
  • Patient who provides signed and dated informed consent

You may not qualify if:

  • Implanted or planned to be implanted non MR-compatible device or material
  • Permanent Atrial Fibrillation (for DR devices)
  • Diaphragmatic/phrenic stimulation
  • Claustrophobia
  • Incessant ventricular tachyarrhythmia
  • Inability to understand the purpose of the study or refusal to co-operate
  • Unavailability for scheduled follow-ups at the implanting centre
  • Already included in another clinical trial that could affect the results of this study
  • Patient is minor (less than 18-years old)
  • Patient is pregnant - Patient is forfeiture of freedom or under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Charles Nicolle

Rouen, 76000, France

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arnaud Mr SAVOURE, cardiologist

    CHU Charles Nicolle - 1 rue Germont, 76000 ROUEN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 26, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

April 23, 2019

Record last verified: 2019-04

Locations

FR(1)