Status:
WITHDRAWN
Micra AV Tracking During Exercise Testing
Lead Sponsor:
Duke University
Conditions:
Heart Block AV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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, participa...
Detailed Description
Participants will be screened and eligible participants who express informed consent will complete exercise testing and holter monitoring. For each participant, the tracking performance of the atrial ...
Eligibility Criteria
Inclusion
- Age ≥18
- Written informed consent
- Presence of a Micra AV leadless pacemaker with the Micra AV 2.0 algorithm and at least 50% RV pacing
- High grade atrioventricular heart block as the primary indication for permanent pacing
- Sinus rhythm
- Physical ability to walk on a treadmill or ride a recumbent bicycle for exercise testing
Exclusion
- Earlier version of the Micra leadless pacemaker
- Intact atrioventricular conduction
- Persistent atrial fibrillation
- Those with absolute contraindications to exercise testing:
- Acute myocardial infarction (MI) within 2 days
- Ongoing unstable angina
- Uncontrolled cardiac arrhythmia with hemodynamic compromise
- Active endocarditis
- Symptomatic severe aortic stenosis
- Decompensated heart failure
- Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
- Acute myocarditis or pericarditis
- Acute aortic dissection
- Physical disability that precludes safe and adequate testing
- Inability to consent
- Patient refusal to participate
- Pregnant patients
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05966168
Start Date
May 1 2024
End Date
November 1 2025
Last Update
April 17 2024
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710