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Medtronic Micra AV Device for Atrioventricular Heart Block
Phase 4
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average tracking index at rest
Average tracking index during exercise
Average tracking index during recovery
Secondary outcome measures
Average total AV synchrony
Average total AV synchrony at rest
Average total AV synchrony during exercise
+6 moreTrial 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
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,420,049 Total Patients Enrolled
Camille Frazier-MillsPrincipal InvestigatorDuke Medicine - Cardiology
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to give consent by myself.I am 18 years old or older.My heart's electrical system is functioning properly.I have ongoing irregular heartbeats.I can walk on a treadmill or ride a recumbent bike for tests.You have an older version of the Micra leadless pacemaker.I do not want to participate in the clinical trial.I have a physical disability that makes testing unsafe or difficult for me.I have a Micra AV leadless pacemaker with at least 50% RV pacing.I need a pacemaker due to a severe heart rhythm problem.Your heart is beating normally in a regular pattern.I cannot do exercise tests due to serious heart or lung conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Micra AV Exercise Testing
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks does participation in Micra AV Exercise Testing pose to individuals?
"Clinical data indicates that the Micra AV Exercise Testing system is safe and has been approved, thus it achieved a score of 3."
Answered by AI
Is this clinical trial open to new participants?
"Clinicaltrials.gov reports that this medical trial, which was first published on July 1st 2023 and recently updated shortly after on the 21st of June, is not presently recruiting patients. Nevertheless, there are 20 other trials actively searching for new participants at present."
Answered by AI
What objective is this exploration seeking to accomplish?
"Over a 6 month period, the aim of this medical trial is to gauge average tracking index during exercise. Secondary objectives include measuring average total AV synchrony during both physical activity and recovery (calculated as AM-VP percentage plus AM-VS percentage), as well as an assessment of Average tracking index across 10 bpm ranges between 55 bpm and 135 bpm."
Answered by AI
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