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Micra AV Tracking During Exercise Testing

NCT05966168 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-04-17

No results posted yet for this study

Summary

The purpose of this study is to determine the effectiveness of the Micra AV 2.0 device during exercise or elevated heart rates. Participation in research studies is voluntary. In this study, participants will already be planned to have a Micra AV 2.0 device implanted. Participants will then undergo treadmill exercise testing and wear a Holter monitor. For each participant, the tracking performance of the Micra AV 2.0 will be evaluated at rest and during exercise. Follow up visits will occur as part of standard of care and each participant will be enrolled in the study for up to 6 months.

Conditions

  • Heart Block AV

Interventions

DEVICE

Medtronic Micra AV Device

Participants will already be planned to have a Micra AV 2.0 device implanted. Participants will then undergo treadmill exercise testing and wear a Holter monitor to determine the effectiveness of the Micra AV 2.0 device during exercise or elevated heart rates.

Sponsors & Collaborators

Principal Investigators

  • Camille Frazier-Mills · Duke Medicine - Cardiology

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-11-30
Completion
2025-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT05966168 on ClinicalTrials.gov