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Micra Atrial TRacking Using A Ventricular AccELerometer 2

NCT03752151 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2020-06-04

Study results available
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Summary

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

Conditions

  • Atrioventricular Conduction Block

Interventions

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

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-22
Primary Completion
2019-08-07
Completion
2019-08-07
FDA Device
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Denmark
  • France
  • Hong Kong
  • 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 NCT03752151 on ClinicalTrials.gov