SEEQ™ Performance Study

NCT ID: NCT02484898

Last Updated: 2016-11-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-08-31

Brief Summary

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The purpose of the Medtronic SEEQ™ Performance study is to build further evidence on the clinical and economic benefit of the Medtronic market-released SEEQ™ Mobile Cardiac Telemetry System/External Cardiac Monitor System (MCT/ECM).

Detailed Description

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Conditions

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Arrhythmia Type Unknown

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SEEQ™ MCT/ECM System

SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patient is indicated for a SEEQ™ MCT/ECM System for approved indications
* Patient is 18 years of age or older
* Patient is willing and able to provide consent and authorize the use and disclosure of health information
* Patient is willing and able to comply with the protocol

Exclusion Criteria

* Patient has known allergy and/or hypersensitivity to adhesives or hydrogel.
* Patient has suspected potential life-threatening arrhythmias, or requires in-subject/in-hospital monitoring.
* Patient will undergo a medical procedure that would preclude full participate during the prescribed duration of the SEEQ™
* Patient has an implanted cardiac device, (e.g., pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SEEQ Performance Study Clinical Team

Role: STUDY_DIRECTOR

Medtronic

Locations

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Larkspur, California, United States

Site Status

Simi Valley, California, United States

Site Status

Aurora, Colorado, United States

Site Status

Clearwater, Florida, United States

Site Status

Palm Beach Gardens, Florida, United States

Site Status

Sebring, Florida, United States

Site Status

Rome, Georgia, United States

Site Status

Jackson, Mississippi, United States

Site Status

Henderson, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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SEEQ™ Performance Study

Identifier Type: -

Identifier Source: org_study_id