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Micra Atrial Tracking Using a Ventricular Accelerometer Study (MARVEL)

Primary Purpose

Atrioventricular Conduction Block

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MARVEL algorithm
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Atrioventricular Conduction Block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist Medical Center Jacksonville
  • Baptist Hospital
  • Emory University Hospital
  • NYU Langone Medical Center
  • Kepler Universitätsklinikum Med Campus III
  • UZ Leuven - Campus Gasthuisberg
  • Nemocnice Na Homolce
  • Odense Universitetshospital
  • Hôpital Haut-Lévêque - CHU de Bordeaux
  • Maria Cecilia Hospital
  • Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
  • Institut Jantung Negara
  • Hospital Universitari Clínic de Barcelona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enrolled

Arm Description

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

Outcomes

Primary Outcome Measures

Atrioventricular synchrony
On an individual heartbeat basis, this is defined as a right ventricular paced or sensed R-wave associated with an ECG confirmed P-wave.
MARVEL Evolve Substudy
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.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2017
Last Updated
October 24, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT03157297
Brief Title
Micra Atrial Tracking Using a Ventricular Accelerometer Study
Acronym
MARVEL
Official Title
Micra Atrial Tracking Using a Ventricular Accelerometer Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
November 24, 2017 (Actual)
Study Completion Date
November 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrioventricular Conduction Block

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enrolled
Arm Type
Experimental
Arm Description
Subjects enrolled in the MARVEL study. Enrolled subjects will have the MARVEL algorithm downloaded into their implanted market released Micra device.
Intervention Type
Device
Intervention Name(s)
MARVEL algorithm
Intervention Description
Software download into implanted Micra device
Primary Outcome Measure Information:
Title
Atrioventricular synchrony
Description
On an individual heartbeat basis, this is defined as a right ventricular paced or sensed R-wave associated with an ECG confirmed P-wave.
Time Frame
Initial 24 hour period after patient enrollment
Title
MARVEL Evolve Substudy
Description
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.
Time Frame
Initial 24 hour period after patient enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Baptist Medical Center Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Baptist Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1059
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Kepler Universitätsklinikum Med Campus III
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
UZ Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Nemocnice Na Homolce
City
Praha 5
State/Province
Czech Republic
ZIP/Postal Code
150 30
Country
Czechia
Facility Name
Odense Universitetshospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Hôpital Haut-Lévêque - CHU de Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Maria Cecilia Hospital
City
Cotignola
State/Province
Ravenna
ZIP/Postal Code
48033
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Institut Jantung Negara
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Hospital Universitari Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29758405
Citation
Chinitz L, Ritter P, Khelae SK, Iacopino S, Garweg C, Grazia-Bongiorni M, Neuzil P, Johansen JB, Mont L, Gonzalez E, Sagi V, Duray GZ, Clementy N, Sheldon T, Splett V, Stromberg K, Wood N, Steinwender C. Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies. Heart Rhythm. 2018 Sep;15(9):1363-1371. doi: 10.1016/j.hrthm.2018.05.004. Epub 2018 May 11.
Results Reference
derived

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Micra Atrial Tracking Using a Ventricular Accelerometer Study

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