Micra Atrial TRacking Using A Ventricular AccELerometer 2 (MARVEL2)

May 29, 2020 updated by: Medtronic Cardiac Rhythm and Heart Failure
The purpose of the Micra Atrial TRacking Using A Ventricular AccELerometer 2 (MARVEL 2) study is to demonstrate safe and effective operation of the MARVEL 2 features for providing AV synchronous pacing in patients with normal sinus node function and AV block

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The MARVEL 2 study is an acute, prospective, global, multi-center, software-download clinical study. The study is planned to be conducted in US, Europe, and Asia. The study is expected to be conducted at approximately 15-20 centers in up to 100 subjects to obtain at least 70 usable Holter datasets to meet the objectives of the study. The expected total study duration (from first subject enrollment to the exit of the last subject) is approximately 6-months; this represents the time necessary to enroll the target sample size of at least 70 subjects with usable Holter datasets. Software will be downloaded into patients implanted with a Micra device to allow the new algorithm performance to be measured in patients where a Micra device has already been chosen as most appropriate for the patient.

Most enrolled subjects will complete the study procedures during a single study visit. However, subjects enrolling in the study at the time of their Micra implant (anticipated to be approximately 10 subjects) will have the investigational algorithm downloaded following Micra implant, prior to hospital discharge, and approximately 1-month post-implant. This subset of subjects with de novo Micra implants will allow the MARVEL 2 features to be tested at multiple points in the device life cycle.

Since the download algorithm running in a Micra device significantly increases current drain, a 2-4 hour acute study is used to limit the reduction in device longevity.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

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, 4020
        • Kepler Universitatsklinikum Med Campus III
  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven - Campus Gasthuisberg
  • Denmark
      • Odense C, Denmark
        • Odense Universitetshospital
  • France
      • Pessac, France, 33604
        • Hôpital Haut-Lévêque - CHU de Bordeaux
  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales 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
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital- Northwell
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University 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 a Micra TPS (Model MC1VR01) with remaining device longevity of 6 years or more or is expected to be implanted with a Micra TPS.
  • Subject has history of AV block*
  • Subject is ≥ 18 years old and as per required local law.
  • 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. *This includes subjects with normal sinus function and persistent 3rd degree AV block and subjects with other forms of AV block.

Exclusion Criteria:

  • 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 Clinical Research Specialist.
  • Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MARVEL 2 study procedures).
  • Subject meets any exclusion criteria required by local law (age or other).

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: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MARVEL 2 Algorithm Monitor Mode, Then MARVEL 2 Adaptive Mode
Participants first received MARVEL 2 algorithm monitor mode which provides standard VVI pacing for approximately 20 minutes followed by MARVEL 2 algorithm adaptive mode for approximately 2 hours which provides VDD pacing.
Device: MARVEL 2 Algorithm Monitor Mode then Adaptive Mode
Software download into implanted Micra device and programmed to MARVEL 2 Monitor Mode then MARVEL 2 Adaptive Mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial Ventricular Pacing Synchrony Success During Rest
Time Frame: 40 Minutes
A subject will meet the primary endpoint if a paced or sensed ventricular beat is within 300 ms following an ECG confirmed P-wave for at least 70% of the ECG confirmed P-waves. The primary endpoint will be evaluated during the MARVEL 2 setup phase during MARVEL 2 Algorithm monitor mode (VDI pacing which is effectively VVI pacing) and during the 20-minute resting period in which the MARVEL 2 Algorithm is programmed to Adaptive mode (VDD pacing)
40 Minutes
Number of Participants Free From Inappropriate Pacemaker Function Events
Time Frame: Through study completion an average of one day

A participant will meet the primary endpoint if they are free from the following MARVEL 2 software related events during the entire Holter monitoring period where the MARVEL 2 features are enabled.

Inappropriate pacemaker function events are defined as:

  1. Cardiac pauses lasting longer than 2 cardiac cycles (where cardiac cycle length is defined by the programmed lower rate interval of the pacemaker), OR
  2. Pacemaker oversensing induced tachycardia exceeding 3-minutes, defined as oversensing of the pacemaker's accelerometer signal leading to a heart rate exceeding 100 beats per minute.
Through study completion an average of one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left Ventricular Outflow Tract Velocity Time Integral
Time Frame: 12 cardiac cycles
The secondary endpoint is left ventricular outflow tract (LVOT) velocity time integral (VTI) as obtained from echocardiogram while the MARVEL 2 features are in adaptive mode (VDD pacing) and while the MARVEL 2 features are in monitor mode (VDI pacing which is effectively VVI pacing). This was measured by the echo core laboratory that was blinded to the study participant and MARVEL 2 algorithm mode.
12 cardiac cycles

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)

January 22, 2019

Primary Completion (Actual)

August 7, 2019

Study Completion (Actual)

August 7, 2019

Study Registration Dates

First Submitted

November 14, 2018

First Submitted That Met QC Criteria

November 21, 2018

First Posted (Actual)

November 23, 2018

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

May 29, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT18024

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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