NCT02933619

Brief Summary

Following product approval, confirmation of appropriate VF episode detection after MRI exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold changes post-MRI.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24,249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

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

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

2.7 years

First QC Date

October 10, 2016

Last Update Submit

October 18, 2019

Conditions

Tachyarrhythmia

Outcome Measures

Primary Outcomes (2)

  • Proportion of ICD/CRT-D subjects with a ≥ 5 second delay in post-MRI VF detection.

    Primary objectives will be analyzed once 25 subjects implanted with the ProMRI ICD system have been identified with a documented true VF episode post-MRI.

    Up to 5 years post-approval

  • Proportion of LV pacing leads with a LV pacing threshold increase > 1V between pre-MRI and one-month post-MRI.

    Up to 5 years post-approval

Secondary Outcomes (2)

  • Workflow compliance following MR exposure

    Up to 5 years post-approval

  • Left ventricular sensing attenuation

    Up to 5 years post-approval

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring.

You may qualify if:

  • ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 14, 2016

Study Start

August 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10