Evaluation of VDD Leadless Pacing System During Exercise
NCT ID: NCT06094114
Last Updated: 2023-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2022-04-01
2022-12-31
Brief Summary
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Only patients who were previously implanted with a Micra MC1AVR01 can be enrolled in the study. Exercise test is part of the standard clinical care practice for this patients population during the first year follow-up.
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Detailed Description
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1. Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise
2. Characterize the AV synchrony percentage provided by the Micra AV during exercise.
3. Confirm the safety of the Micra AV during exercise
Only patients who were previously implanted with a Micra MC1AVR01 can be enrolled in the study. All subjects provide signed and dated consent that he/she is willing and able to comply with the protocol.
Retrospective patients enrollment is allowed to facilitate a more rapid performance assessment in patients previously implanted with a Micra AV for whom an exercise test has already been performed.
Exercise test The Micra AV permits AV synchronous pacing mode up to a maximal sinus rate of 115/min. Exercise test will therefore be performed up to a maximal heart rate of 115/min. The test will be stopped by the patient (depending on his/her ability/symptoms such as: fatigue, dyspnea, leg pain,..) or by the cardiologist if a maximal heart rate of 115 beats per minute is reached.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with Micra Av
Only patients who were previously implanted with a Micra MC1AVR01 can be enrolled in the study. Patients need to be able to perform an exercise test. All subjects provide signed and dated consent that he/she is willing and able to comply with the protocol.
pacemaker follow-up
Performance of an exercise test in patients previously implanted with Micra AV
Interventions
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pacemaker follow-up
Performance of an exercise test in patients previously implanted with Micra AV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed and dated consent (patient confirms that he/she is willing and able to comply with the protocol)
* Patient is physically able to perform an exercise test (cycle test).
Retrospective patients enrolment is allowed to facilitate a more rapid performance assessment in patients previously implanted with a Micra AV for whom an exercise test has already been performed.
Co-enrolment in the Micra AV post-approvals study is allowed.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medtronics, Inc.
INDUSTRY
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Christophe Garweg, MD,PHD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals of Leuven, cardiovascular department
Locations
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University Hospitals of Leuven
Leuven, , Belgium
Countries
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Other Identifiers
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s65477
Identifier Type: -
Identifier Source: org_study_id
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