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| Name | Class |
|---|---|
| Medtronics, Inc. | INDUSTRY |
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The study is a non-randomized, active prospective observational study permitting to report the behavior of Micra AV pacemaker during an exercise.
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.
The purpose of this observational study is to obtain additional data on behavior and safety of the Micra MC1AVR01 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pacemaker follow-up | Device | Performance of an exercise test in patients previously implanted with Micra AV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise | Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise | Exercise test is performed during the first year following the Micra implantation |
| Characterize the AV synchrony percentage provided by the Micra AV during exercise. | Characterize the AV synchrony percentage provided by the Micra AV during exercise. | Exercise test is performed during the first year following the Micra implantation |
| Confirm the safety of the Micra AV during exercise | Confirm the safety of the Micra AV during exercise confirmed by the absence of (1) pauses exceeding 2 paced cardiac cycles and (2) oversensing induced tachyarrhythmia exceeding 130 bpm. | Exercise test is performed during the first year following the Micra implantation |
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Inclusion Criteria:
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:
- Frail patient unable to perform an exercise test (cycle test).
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Patients previously implanted with Micra AV
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Garweg, MD,PHD | University Hospitals of Leuven, cardiovascular department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Leuven | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |