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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | Other | Subjects implanted with the Medtronic Micra AV device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerometer Sensing for Micra AV Study | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-month post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Subject will be implanted with a MicraTM (Model MC1AVR1) for an approved indication.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry Chinitz, MD | NYU Langone | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Joseph's Medical Center | Stockton | California | 95204 | United States | ||
| Baptist Medical Center Jacksonville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36075532 | Derived | 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. |
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Following enrollment, subjects were implanted with the Micra AV device and completed follow-up visits at 1-month and 3-months post implant. The completed cohort includes subjects implanted with the Micra AV device who had a persistent 3rd degree AV block and normal sinus node function at the 1-month visit.
Subjects were considered enrolled at time of informed consent. Subjects were enrolled between 09 June 2020 and 14 September 2021 at 20 study centers in 2 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | AccelAV Evaluable for Primary Objective | Subjects implanted with the Micra AV device with a 3rd degree AV block and normal sinus node function at 1-month |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2020 | Dec 14, 2022 |
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| 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. | 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 | Within 48 hours of procedure |
| Jacksonville |
| Florida |
| 32207 |
| United States |
| Citrus Cardiology Consultants PA | Leesburg | Florida | 34748 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Catholic Medical Center | Manchester | New Hampshire | 03102 | United States |
| Northwell Health | Manhasset | New York | 11030 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Duke University Nedical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Mount Carmel Health System | Columbus | Ohio | 43213 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Centennial Heart Cardiovascular Consultants | Nashville | Tennessee | 37203 | United States |
| Baylor Research Institute | Plano | Texas | 75093 | United States |
| Multicare Institute for Research and Innovation | Tacoma | Washington | 98405 | United States |
| University of Wisconsin (UW) Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Queen Mary Hospital | Hong Kong | HK | Hong Kong |
| Prince of Wales Hospital | Shatin | HK | Hong Kong |
| Implanted |
|
| 1-month Visit |
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| Complete Heart Block at 1-month |
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| At Least 500 Evaluable Beats |
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| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AccelAV Enrolled Cohort | Subjects enrolled in the AccelAV study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 3 subjects did not have age reported | Count of Participants | Participants |
| |||||||||||||||||
| Age, Continuous | 3 subjects did not have age reported | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | 3 subjects did not have sex reported | Count of Participants | Participants |
| |||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index (BMI) | BMI was not available for 7 subjects | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||||
| Comorbidities | Count of Participants | Participants |
| ||||||||||||||||||
| Preclusion for Transvenous Pacing | Count of Participants | Participants |
| ||||||||||||||||||
| Cardiac Perforation Risk | Count of Participants | Participants |
| ||||||||||||||||||
| Pacing Indication | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | Percentage of P-waves | 1-month post-implant |
|
|
| ||||||||||||||||||||||||||
| Secondary | 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). | Subjects were required to have a predominant heart rhythm of persistent 3rd degree AV block and normal sinus node function at both the 1-month and 3-month visits. Of the 54 subjects with persistent 3rd degree AV block an normal sinus function at 1-month, 37 of these remained in persistent 3rd degree AV block an normal sinus function at 3-months and were included in the analysis of this objective. | Posted | Mean | 95% Confidence Interval | Percentage of P-waves | Between 1-month and 3-months post-implant |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | Percentage | 1-month post-implant |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | The analysis population is a subset of the enrolled population. Specifically, of the 157 enrolled, 78 subjects had a predominant rhythm of persistent 3rd degree AV block and normal sinus rhythm at the time of implant. Of these, 67 had LVOT VTI measurements in both VVI and VDD modes. Of these 67, 47 had a heart rate within 15 beats per minute in both pacing modes and were included in the analysis of this objective as pre-specified in the study protocol. | Posted | Mean | 95% Confidence Interval | cm | Within 48 hours of procedure |
|
|
Adverse events were collected from the time of consent through 3-month follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AccelAV Enrolled Cohort | Subjects enrolled in the AccelAV study | 2 | 157 | 45 | 157 | 27 | 157 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Haemorrhage intracranial | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Device pacing issue | Product Issues | MedDRA 24.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral vein occlusion | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Implant site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pacemaker syndrome | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Puncture site haemorrhage | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vascular access site haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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PIs will not publish/present results until a multi-center pub. is released. If a multi-center pub. is not released within 1 year of completion PI may publish the results pertaining to their activities. Pubs will be provided to MDT at least 60 days prior to submission or presentation for review. Within 60 days of receipt, MDT will verify presence of CI or technical errors. PI will make requested changes prior to publication/presentation. PI will delay publication up to 90 more days if requested.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Vasseur, Sr. Clinical Research Specialist | Medtronic | 6123550360 | rachel.s.vasseur@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2021 | Dec 15, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
|
| Male |
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| Diabetes |
|
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| Coronary Artery Disease |
|
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| Myocardial infarction |
|
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| Chronic Obstructive Pulmonary Disease |
|
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| Dialysis |
|
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| High |
|
| Unavailable |
|
|
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| Atrioventricular (AV) Block |
|
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| Syncope |
|
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| Other |
|
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| Unavailable |
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