3rd Degree Heart Block, AV Block, AV Block Complete, Complete Heart Block
Conditions
Keywords
AV Synchrony, Micra AV, Micra, Transcatheter Pacing, Normal Sinus Node Function, Leadless Pacemaker
Brief 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.
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.
Interventions
DEVICEAccelerometer Sensing for Micra AV Study
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.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrioventricular (AV) Synchrony During Rest at 1-month Post-implant in Subjects With Persistent 3rd Degree Atrioventrcular Block (AVB) and Normal Sinus Node Function | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Between 1-month and 3-months post-implant | 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). |
| Percentage of Ambulatory AV Synchrony at 1-month Post-implant in Subjects With Persistent 3rd Degree AVB and Normal Sinus Node Function | 1-month post-implant | 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. |
| Left Ventricular Outflow Tract Velocity Time Integral | Within 48 hours of procedure | 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 |
Countries
Hong Kong, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| AccelAV Enrolled Cohort Subjects enrolled in the AccelAV study | 157 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Exited prior to 1-month | 9 |
| Overall Study | Exited prior to implant | 5 |
| Overall Study | Fewer than 500 evaluable beats | 2 |
| Overall Study | Missed 1-month visit | 3 |
| Overall Study | Predominant rhythm exclusion at 1-month | 83 |
Baseline characteristics
| Characteristic | AccelAV Enrolled Cohort | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 137 Participants | — |
| Age, Categorical Between 18 and 65 years | 17 Participants | — |
| Age, Continuous | 77.2 years STANDARD_DEVIATION 10.8 | — |
| Body Mass Index (BMI) | 28.2 kg/m^2 STANDARD_DEVIATION 7 | — |
| Cardiac Perforation Risk High | 37 Participants | — |
| Cardiac Perforation Risk Low | 74 Participants | — |
| Cardiac Perforation Risk Medium | 39 Participants | — |
| Cardiac Perforation Risk Unavailable | 7 Participants | — |
| Comorbidities Atrial fibrillation | 20 Participants | — |
| Comorbidities Chronic Obstructive Pulmonary Disease | 29 Participants | — |
| Comorbidities Coronary Artery Disease | 66 Participants | — |
| Comorbidities Diabetes | 63 Participants | — |
| Comorbidities Dialysis | 13 Participants | — |
| Comorbidities Hypertension | 123 Participants | — |
| Comorbidities Myocardial infarction | 12 Participants | — |
| Pacing Indication Atrioventricular (AV) Block | 137 Participants | — |
| Pacing Indication Bradyarrhythmia with atrial fibrillation (AF) | 5 Participants | — |
| Pacing Indication Other | 4 Participants | — |
| Pacing Indication Sinus Node Dysfunction | 7 Participants | — |
| Pacing Indication Syncope | 1 Participants | — |
| Pacing Indication Unavailable | 3 Participants | — |
| Preclusion for Transvenous Pacing | 37 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Hong Kong | 19 Participants | — |
| Region of Enrollment United States | 138 Participants | — |
| Sex: Female, Male Female | 73 Participants | — |
| Sex: Female, Male Male | 81 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 157 |
| other Total, other adverse events | 27 / 157 |
| serious Total, serious adverse events | 45 / 157 |
Outcome results
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.
Time frame: 1-month post-implant
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AccelAV Evaluable for Primary Objective | Atrioventricular (AV) Synchrony During Rest at 1-month Post-implant in Subjects With Persistent 3rd Degree Atrioventrcular Block (AVB) and Normal Sinus Node Function | 85.4 Percentage of P-waves |
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
Time frame: Within 48 hours of procedure
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AccelAV Evaluable for Primary Objective | Left Ventricular Outflow Tract Velocity Time Integral | LVOT VTI during VVI mode | 21.4 cm |
| AccelAV Evaluable for Primary Objective | Left Ventricular Outflow Tract Velocity Time Integral | LVOT VTI during VDD mode | 23.7 cm |
| AccelAV Evaluable for Primary Objective | Left Ventricular Outflow Tract Velocity Time Integral | LVOT VTI difference (VDD-VVI) | 2.3 cm |
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.
Time frame: 1-month post-implant
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AccelAV Evaluable for Primary Objective | Percentage of Ambulatory AV Synchrony at 1-month Post-implant in Subjects With Persistent 3rd Degree AVB and Normal Sinus Node Function | 74.5 Percentage |
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).
Time frame: Between 1-month and 3-months post-implant
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AccelAV Evaluable for Primary Objective | 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 at 1-month | 86.1 Percentage of P-waves |
| AccelAV Evaluable for Primary Objective | 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 at 3-months | 84.1 Percentage of P-waves |
| AccelAV Evaluable for Primary Objective | 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 | Difference in AV Synchrony (Month 3 - Month 1) | -2.0 Percentage of P-waves |