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Medtronic Micra AV Device for Atrioventricular Heart Block

Phase 4
Waitlist Available
Led By Camille Frazier-Mills
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18
Physical ability to walk on a treadmill or ride a recumbent bicycle for exercise testing
Must not have
Inability to consent
Intact atrioventricular conduction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial will study the performance of a heart device during exercise & elevated heart rates in participants who already have it implanted. They'll undergo tests & wear a monitor. Each participant will be in the study for 6 months.

Who is the study for?
This trial is for adults over 18 with high-grade atrioventricular heart block who need a Micra AV pacemaker and can walk on a treadmill or ride a bike. It's not for those with physical disabilities preventing safe testing, pregnant women, patients unable to consent, or anyone with conditions that make exercise testing unsafe.
What is being tested?
The study tests the effectiveness of the Micra AV 2.0 device in tracking heart activity during rest and exercise in patients requiring pacing due to heart block. Participants will have this device implanted, undergo treadmill tests, wear a Holter monitor, and be monitored up to six months.
What are the potential side effects?
While specific side effects are not listed for this trial, typical risks may include discomfort from wearing the Holter monitor or complications related to having the Micra AV pacemaker like infection or lead displacement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can walk on a treadmill or ride a recumbent bike for tests.
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I have a Micra AV leadless pacemaker with at least 50% RV pacing.
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I need a pacemaker due to a severe heart rhythm problem.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to give consent by myself.
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My heart's electrical system is functioning properly.
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I have ongoing irregular heartbeats.
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I do not want to participate in the clinical trial.
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I have a physical disability that makes testing unsafe or difficult for me.
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I cannot do exercise tests due to serious heart or lung conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average tracking index at rest
Average tracking index during exercise
Average tracking index during recovery
Secondary study objectives
Average total AV synchrony
Average total AV synchrony at rest
Average total AV synchrony during exercise
+6 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Micra AV Exercise TestingExperimental Treatment1 Intervention
All participants will have Micra AV 2.0 implanted then undergo exercise testing while wearing Holter Monitor

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,458 Previous Clinical Trials
2,969,449 Total Patients Enrolled
Camille Frazier-MillsPrincipal InvestigatorDuke Medicine - Cardiology

Media Library

Micra AV Exercise Testing Clinical Trial Eligibility Overview. Trial Name: NCT05966168 — Phase 4
Atrioventricular Heart Block Research Study Groups: Micra AV Exercise Testing
Atrioventricular Heart Block Clinical Trial 2023: Micra AV Exercise Testing Highlights & Side Effects. Trial Name: NCT05966168 — Phase 4
Micra AV Exercise Testing 2023 Treatment Timeline for Medical Study. Trial Name: NCT05966168 — Phase 4
~0 spots leftby Nov 2025
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