BradycardiaNCT06094114
Evaluation of VDD Leadless Pacing System During Exercise
An observational study of Bradycardia and Pacemaker DDD, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Pacemaker DDD
- What is being tested?
- pacemaker follow-up
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients previously implanted with Micra AV
Who may be able to join
- Patients previously implanted with a Micra MC1AVR01
- 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.
Who cannot join
- Frail patient unable to perform an exercise test (cycle test).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Atrio-ventricular Synchronous Pacing Rate During Exercise Test in Patients With a VDD Leadless Pacing System (Micra AV)
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.
Read the detailed description
The purpose of this observational study is to obtain additional data on behavior and safety of the Micra MC1AVR01 during exercise:
- Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise
- Characterize the AV synchrony percentage provided by the Micra AV during exercise.
- 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
- Bradycardia, Pacemaker DDD
- Being tested
- pacemaker follow-up
- Keywords
- leadless pacemaker, Micra
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pacemaker follow-upDevice
Also called Micra AV
Performance of an exercise test in patients previously implanted with Micra AV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: pacemaker follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Exercise test is performed during the first year following the Micra implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Apr 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronics, Inc.
- Responsible party
- Sponsor
- Investigators
- Christophe Garweg, MD,PHD, Principal investigator, University Hospitals of Leuven, cardiovascular department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094114
- Sponsor's protocol ID
- s65477
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Atrio-ventricular Synchronous Pacing Rate During Exercise Test in Patients With a VDD Leadless Pacing System (Micra AV)
- ClinicalTrials.gov ID
- NCT06094114
- Acronym / sponsor ID
- s65477
- Conditions
- Bradycardia, Pacemaker DDD
- Keywords
- leadless pacemaker, Micra
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Medtronics, Inc.
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this observational study is to obtain additional data on behavior and safety of the Micra MC1AVR01 during exercise:
- Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise
- Characterize the AV synchrony percentage provided by the Micra AV during exercise.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Micra Av | – | Device: pacemaker follow-upOnly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients previously implanted with Micra AV
Key inclusion criteria (5 listed)
- Patients previously implanted with a Micra MC1AVR01
- 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.
Key exclusion criteria (1 listed)
- Frail patient unable to perform an exercise test (cycle test).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pacemaker follow-upAlso: Micra AVPerformance of an exercise test in patients previously implanted with Micra AV | Device | Patients with Micra Av |
Primary outcome
Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise
Time frame: Exercise test is performed during the first year following the Micra implantation
Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise
Characterize the AV synchrony percentage provided by the Micra AV during exercise.
Time frame: Exercise test is performed during the first year following the Micra implantation
Characterize the AV synchrony percentage provided by the Micra AV during exercise.
Confirm the safety of the Micra AV during exercise
Time frame: Exercise test is performed during the first year following the Micra implantation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Garweg, MD,PHD principal investigator
University Hospitals of Leuven, cardiovascular department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia and Pacemaker DDD, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise (time frame: Exercise test is performed during the first year following the Micra implantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.