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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Atrioventricular Conduction Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings