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Micra Atrial Tracking Using a Ventricular Accelerometer Study

NCT03157297 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-10-26

No results posted yet for this study

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.

Conditions

  • Atrioventricular Conduction Block

Interventions

DEVICE

MARVEL algorithm

Software download into implanted Micra device

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-10
Primary Completion
2017-11-24
Completion
2017-11-24
FDA Device
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • France
  • Italy
  • Malaysia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03157297 on ClinicalTrials.gov