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Micra Atrial Tracking Using a Ventricular Accelerometer Study (MARVEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03157297
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Atrioventricular Conduction Block Device: MARVEL algorithm Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Micra Atrial Tracking Using a Ventricular Accelerometer Study
Actual Study Start Date : July 10, 2017
Actual Primary Completion Date : November 24, 2017
Actual Study Completion Date : November 24, 2017

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157297


Locations
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United States, Florida
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States, 32207
Baptist Hospital
Miami, Florida, United States, 33176
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322-1059
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Austria
Kepler Universitätsklinikum Med Campus III
Linz, Austria, 4021
Belgium
UZ Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Czechia
Nemocnice Na Homolce
Praha 5, Czech Republic, Czechia, 150 30
Denmark
Odense Universitetshospital
Odense C, Denmark, 5000
France
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, France, 33604
Italy
Maria Cecilia Hospital
Cotignola, Ravenna, Italy, 48033
Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
Pisa, Italy, 56100
Malaysia
Institut Jantung Negara
Kuala Lumpur, Malaysia, 50400
Spain
Hospital Universitari Clínic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03157297    
Other Study ID Numbers: MDT16064
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Atrioventricular Block
Heart Block
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes