Assessment of the MRI Solution: KORA 100 and Beflex Pacin... | NCT02175797

Studies
Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System

NCT02175797

Sponsor

MicroPort CRM

Status

Completed

Last Update Posted

Apr 23, 2019Actual

Enrollment

33Actual

Phase

Not Applicable

Conditions

Bradycardia

Interventions

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Jun 4, 2014

First Submission Date that Met QC Criteria

Jun 25, 2014

First Posted Date

Jun 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2019

Last Update Posted Date

Apr 23, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pacemaker + leads	Other	all patients must have a MRI exam after pacemaker implantation	Device: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Device	at least 6 weeks after the implantation of the pacemaker a MRI exam is performed	Pacemaker + leads

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure the atrial and ventricular pacing thresholds in Volts before and after the MRI exam, using the programmer.		1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arnaud Mr SAVOURE, cardiologist	CHU Charles Nicolle - 1 rue Germont, 76000 ROUEN	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Charles Nicolle		Rouen		76000	France

Condition Browse Module

MeSH Terms

ID	Term
D001919	Bradycardia

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided