Micra Atrial Tracking Using a Ventricular Accelerometer Study

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

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2017-11-24

Brief Summary

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The purpose of this study is to characterize performance of the MARVEL algorithm downloaded into the MicraTM TPS to provide atrial synchronous ventricular pacing in subjects with AV block.

A sub-study will be conducted within the Marvel study, the purpose of this study is to characterize the MARVEL algorithm in patients who were enrolled in the MARVEL study, and to collect and compare the accelerometer signals and AV synchrony at a second point in time.

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Detailed Description

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Conditions

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Atrioventricular Conduction Block

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Enrolled

Subjects enrolled in the MARVEL study. Enrolled subjects will have the MARVEL algorithm downloaded into their implanted market released Micra device.

Group Type EXPERIMENTAL

MARVEL algorithm

Intervention Type DEVICE

Software download into implanted Micra device

Interventions

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MARVEL algorithm

Software download into implanted Micra device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject has been implanted with, or is expected to be implanted with a MicraTM TPS (Model MC1VR01), with remaining device longevity of 6 years or more.
* Subject is ≥ 18 years old and as per required local law.
* Subject has atrioventricular (AV) block.
* Subject (and/or witness, as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements.
* Subject is willing and able to comply with the protocol.

• Subjects in the MARVEL Sub-Study have previously been enrolled in the MARVEL main study

Exclusion Criteria

* Subject is in atrial arrhythmia at the time of enrollment.
* Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
* Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MARVEL study procedures).

Additional criteria for the MARVEL Evolve Sub-study:

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No