Micra Atrial Tracking Using a Ventricular Accelerometer Study (MARVEL)

October 24, 2018 updated by: Medtronic Cardiac Rhythm and Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4021
        • Kepler Universitatsklinikum Med Campus III
  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven - Campus Gasthuisberg
  • Czechia
    • Czech Republic
      • Praha 5, Czech Republic, Czechia, 150 30
        • Nemocnice Na Homolce
  • Denmark
      • Odense C, Denmark, 5000
        • Odense Universitetshospital
  • France
      • Pessac, France, 33604
        • Hôpital Haut-Lévêque - CHU de Bordeaux
  • Italy
      • Pisa, Italy, 56100
        • Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
    • Ravenna
      • Cotignola, Ravenna, Italy, 48033
        • Maria Cecilia Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Institut Jantung Negara
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Universitari Clínic de Barcelona
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center Jacksonville
      • Miami, Florida, United States, 33176
        • Baptist Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322-1059
        • Emory University Hospital
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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).
  • Subject meets any exclusion criteria required by local law (age or other).

Additional criteria for the MARVEL Evolve Sub-study:

Inclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enrolled
Subjects enrolled in the MARVEL study. Enrolled subjects will have the MARVEL algorithm downloaded into their implanted market released Micra device.
Device: MARVEL algorithm
Software download into implanted Micra device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrioventricular synchrony
Time Frame: Initial 24 hour period after patient enrollment
On an individual heartbeat basis, this is defined as a right ventricular paced or sensed R-wave associated with an ECG confirmed P-wave.
Initial 24 hour period after patient enrollment
MARVEL Evolve Substudy
Time Frame: Initial 24 hour period after patient enrollment
Characterize the rate of atrioventricular synchrony provided by the MARVEL algorithm and compare the accelerometer signal amplitudes and the AV synchrony provided by the MARVEL algorithm with the data collected during the initial MARVEL procedure.
Initial 24 hour period after patient enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2017

Primary Completion (Actual)

November 24, 2017

Study Completion (Actual)

November 24, 2017

Study Registration Dates

First Submitted

May 9, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

October 26, 2018

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT16064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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