AV BlockAccelAVNCT04245345
Accelerometer Sensing for Micra AV Study
A study testing Accelerometer Sensing for Micra AV Study in people with AV Block and AV Block Complete, run by Medtronic Cardiac Rhythm and Heart Failure at 20 sites in 2 countries.
Trial summary
The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AV Block, AV Block Complete, 3rd Degree Heart Block
- What is being tested?
- Accelerometer Sensing for Micra AV Study
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 9 Jun 2020to 10 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject will be implanted with a MicraTM (Model MC1AVR1) for an approved indication.
- Subject has history of AV block.
- Subject is ≥ 18 years old and as per required local law.
- Subject (and/or witness as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements.
- Subject is willing and able to comply with the protocol.
Who cannot join
- Subject currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Clinical Research Specialist.
- Subject implanted with a MicraTM (Model MC1AVR1) on a non-permanent basis (e.g. CIED infection).
- Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MicraTM Model MC1AVR1 implant procedures).
- Subject meets any exclusion criteria required by local law (age or other).
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States18 sites
Emory University Hospital
Atlanta, Georgia, 30322
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Mount Carmel Health System
Columbus, Ohio, 43213
Duke University Nedical Center
Durham, North Carolina, 27710
Baptist Medical Center Jacksonville
Jacksonville, Florida, 32207
Citrus Cardiology Consultants PA
Leesburg, Florida, 34748
University of Wisconsin (UW) Hospital and Clinics
Madison, Wisconsin, 53792
Catholic Medical Center
Manchester, New Hampshire, 03102
Northwell Health
Manhasset, New York, 11030
Centennial Heart Cardiovascular Consultants
Nashville, Tennessee, 37203
NYU Langone Medical Center
New York, New York, 10016
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Baylor Research Institute
Plano, Texas, 75093
Oregon Health & Science University
Portland, Oregon, 97239
Saint Joseph's Medical Center
Stockton, California, 95204
Multicare Institute for Research and Innovation
Tacoma, Washington, 98405
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Hong Kong2 sites
Queen Mary Hospital
Hong Kong, HK
Prince of Wales Hospital
Shatin, HK
About this study
The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System.
Read the detailed description
The Accel AV study is a prospective, single-arm, global, multi-center clinical study to characterize the chronic AV synchrony in subjects implanted with the market released Micra AV system. The study is planned to be conducted in the US and Hong Kong. Overall, the study is expected to be conducted at approximately 20 centers.The expected total study duration is approximately 12-15 months, representing the time necessary to enroll the target sample size and to complete the 3-month follow-up visit.
- Being tested
- Accelerometer Sensing for Micra AV Study
- Keywords
- AV Synchrony, Micra AV, Micra, Transcatheter Pacing, Normal Sinus Node Function, Leadless Pacemaker
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerometer Sensing for Micra AV StudyDevice
Characterize AV synchrony in subjects implanted with Micra AV device. The study will be conducted upon market approval of the Micra AV Transcatheter Pacing System.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Other | Subjects implanted with the Medtronic Micra AV device Receives: Device: Accelerometer Sensing for Micra AV Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrioventricular (AV) Synchrony During Rest at 1-month Post-implant in Subjects With Persistent 3rd Degree Atrioventrcular Block (AVB) and Normal Sinus Node Function
Atrioventricular synchrony is defined for each P-wave during the 20-minute resting period. Specifically, for each electrocardiogram (ECG) confirmed P-wave that occurs during the 20-minute resting period at the 1-month visit, the endpoint will be considered met if a ventricular beat (ventricular pace or sensed event) is within 300 ms following an ECG confirmed P-wave. The reported percentage is the average percentage of P-waves considered synchronous across all patients during the 20-minute resting period.
Measured: 1-month post-implant
Secondary outcomes (3)
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
AV synchrony is defined for each ECG confirmed P-wave that occurs during the 20-minute resting period at both the 1-month visit and 3-months visits. For each P-wave the endpoint will be considered met if a ventricular beat (ventricular pace or sensed event) is within 300 ms following an ECG confirmed P-wave. The reported percentages are the average percentage of P-waves considered synchronous across all patients during the 20-minute resting period at each visit (month 1 or month 3).
Measured: Between 1-month and 3-months post-implant
Percentage of Ambulatory AV Synchrony at 1-month Post-implant in Subjects With Persistent 3rd Degree AVB and Normal Sinus Node Function
AV synchrony is defined for each P-wave during the the 24-hour Holter monitoring period while the subject went about their activities of daily living. Specifically, for each electrocardiogram (ECG) confirmed P-wave that occurs during the 24-hour Holter period at the 1-month visit, the endpoint will be considered met if a ventricular beat (ventricular pace or sensed event) is within 300 ms following an ECG confirmed P-wave. The reported percentage is the average percentage of P-waves considered synchronous across all patients during the 24-hour Holter monitoring period.
Measured: 1-month post-implant
Left Ventricular Outflow Tract Velocity Time Integral
Characterize the change in stroke volume, as measured by left ventricular outflow tract (LVOT) velocity time Integral (VTI), during Micra AV mediated VDD (atrioventricular synchronous ventricular pacing) pacing and VVI (asynchronous ventricular pacing) pacing in subjects with persistent 3rd degree AV block and normal sinus node function
Measured: Within 48 hours of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start9 Jun 2020
- Primary completion1 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AV BlockStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry Chinitz, MD, Study chair, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245345
- Sponsor's protocol ID
- AccelAV
- Acronym
- AccelAV
- Status last verified
- Feb 2023
- First submitted
- 21 Jan 2020
- Last updated
- 23 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Chinitz LA, El-Chami MF, Sagi V, Garcia H, Hackett FK, Leal M, Whalen P, Henrikson CA, Greenspon AJ, Sheldon T, Stromberg K, Wood N, Fagan DH, Sun Chan JY. Ambulatory atrioventricular synchronous pacing over time using a leadless ventricular pacemaker: Primary results from the AccelAV study. Heart Rhythm. 2023 Jan;20(1):46-54. doi: 10.1016/j.hrthm.2022.08.033. Epub 2022 Sep 6.
PubMed 36075532
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerometer Sensing for Micra AV Study
- ClinicalTrials.gov ID
- NCT04245345
- Acronym / sponsor ID
- AccelAV / AccelAV
- Keywords
- AV Synchrony, Micra AV, Micra, Transcatheter Pacing, Normal Sinus Node Function, Leadless Pacemaker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Posted 13 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System.
Detailed description
The Accel AV study is a prospective, single-arm, global, multi-center clinical study to characterize the chronic AV synchrony in subjects implanted with the market released Micra AV system. The study is planned to be conducted in the US and Hong Kong. Overall, the study is expected to be conducted at approximately 20 centers.The expected total study duration is approximately 12-15 months, representing the time necessary to enroll the target sample size and to complete the 3-month follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Other | Device: Accelerometer Sensing for Micra AV StudySubjects implanted with the Medtronic Micra AV device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject will be implanted with a MicraTM (Model MC1AVR1) for an approved indication.
- Subject has history of AV block.
- Subject is ≥ 18 years old and as per required local law.
- Subject (and/or witness as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements.
- Subject is willing and able to comply with the protocol.
Key exclusion criteria (4 listed)
- Subject currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Clinical Research Specialist.
- Subject implanted with a MicraTM (Model MC1AVR1) on a non-permanent basis (e.g. CIED infection).
- Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MicraTM Model MC1AVR1 implant procedures).
- Subject meets any exclusion criteria required by local law (age or other).
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 |
|---|---|---|
| Accelerometer Sensing for Micra AV StudyCharacterize AV synchrony in subjects implanted with Micra AV device. The study will be conducted upon market approval of the Micra AV Transcatheter Pacing System. | Device | Single-arm |
Primary outcome
Atrioventricular (AV) Synchrony During Rest at 1-month Post-implant in Subjects With Persistent 3rd Degree Atrioventrcular Block (AVB) and Normal Sinus Node Function
Time frame: 1-month post-implant
Atrioventricular synchrony is defined for each P-wave during the 20-minute resting period. Specifically, for each electrocardiogram (ECG) confirmed P-wave that occurs during the 20-minute resting period at the 1-month visit, the endpoint will be considered met if a ventricular beat (ventricular pace or sensed event) is within 300 ms following an ECG confirmed P-wave. The reported percentage is the average percentage of P-waves considered synchronous across all patients during the 20-minute resting period.
3 secondary outcomes
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
Time frame: Between 1-month and 3-months post-implant
Percentage of Ambulatory AV Synchrony at 1-month Post-implant in Subjects With Persistent 3rd Degree AVB and Normal Sinus Node Function
Time frame: 1-month post-implant
Left Ventricular Outflow Tract Velocity Time Integral
Time frame: Within 48 hours of procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36075532Chinitz LA, El-Chami MF, Sagi V, Garcia H, Hackett FK, Leal M, Whalen P, Henrikson CA, Greenspon AJ, Sheldon T, Stromberg K, Wood N, Fagan DH, Sun Chan JY. Ambulatory atrioventricular synchronous pacing over time using a leadless ventricular pacemaker: Primary results from the AccelAV study. Heart Rhythm. 2023 Jan;20(1):46-54. doi: 10.1016/j.hrthm.2022.08.033. Epub 2022 Sep 6.
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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.
Larry Chinitz, MD study chair
NYU Langone
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometer Sensing for Micra AV Study in people with AV Block and AV Block Complete, run by Medtronic Cardiac Rhythm and Heart Failure at 20 sites in 2 countries.
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 4 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 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Hong Kong. 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?
Yes. Results are posted in the registry (first posted 13 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Atrioventricular (AV) Synchrony During Rest at 1-month Post-implant in Subjects With Persistent 3rd Degree Atrioventrcular Block (AVB) and Normal Sinus Node Function (time frame: 1-month post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04245345, which also lists 1 linked publication.
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 Feb 2023; AzTrials last refreshed its copy on 26 Oct 2026.