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Device
Single-arm for Atrioventricular Block (AccelAV Trial)
N/A
Waitlist Available
Research Sponsored by Medtronic Cardiac Rhythm and Heart Failure
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between 1-month and 3-months post-implant
Awards & highlights
Summary
This trial will study the long-term effects of a new type of pacemaker in people with heart conditions.
Eligible Conditions
- Complete Heart Block
- Atrioventricular Heart Block
- Atrioventricular Block
- Heart Block
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between 1-month and 3-months post-implant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 1-month and 3-months post-implant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Atrioventricular (AV) Synchrony During Rest at 1-month Post-implant in Subjects With Persistent 3rd Degree Atrioventrcular Block (AVB) and Normal Sinus Node Function
Secondary study objectives
Left Ventricular Outflow Tract Velocity Time Integral
Percentage of Ambulatory AV Synchrony at 1-month Post-implant in Subjects With Persistent 3rd Degree AVB and Normal Sinus Node Function
Stability of AV Synchrony During Rest Between 1-month and 3-months Post-implant in Subjects With Persistent 3rd Degree AVB and Normal Sinus Node Function
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single-armExperimental Treatment1 Intervention
Subjects implanted with the Medtronic Micra AV device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Accelerometer Sensing for Micra AV Study
2020
N/A
~160
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Who is running the clinical trial?
Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
201 Previous Clinical Trials
129,929 Total Patients Enrolled
4 Trials studying Atrioventricular Block
1,492 Patients Enrolled for Atrioventricular Block
Larry Chinitz, MDStudy ChairNYU Langone
4 Previous Clinical Trials
663 Total Patients Enrolled
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