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ProMRI ICD/CRT-D Post Approval Study

NCT ID: NCT02933619

Last Updated: 2019-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Tachyarrhythmia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotronik, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ProMRI PAS

Identifier Type: -

Identifier Source: org_study_id

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