Bradycardia, Cardiac Rhythm Disorder
Conditions
Keywords
Bradycardia, Pacemaker, Leadless
Brief summary
prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.
Interventions
Patients will undergo an attempted leadless pacemaker implant
Sponsors
Abbott Medical Devices
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
1. Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including: * Chronic and/or permanent atrial fibrillation with 2° or 3° AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or * Normal sinus rhythm with 2° or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or * Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and 2. Subject is ≥18 years of age; and 3. Subject has a life expectancy of at least one year; and 4. Subject is not enrolled in another clinical investigation; and 5. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and 6. Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC; and 7. Subject is not pregnant and does not plan to get pregnant during the course of the study.
Exclusion criteria
1. Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or 2. Subject is allergic or hypersensitive to \< 1 mg of dexamethasone sodium phosphate (DSP); 3. Subject has a mechanical tricuspid valve prosthesis; or 4. Subject has a pre-existing endocardial pacing or defibrillation leads; or 5. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or 6. Subject has an implanted vena cava filter; or 7. Subject has evidence of thrombosis in one of the veins used for access during the procedure; or 8. Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment; or 9. Subject has an implanted leadless cardiac pacemaker or 10. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication-Free Rate (CFR) | 6 weeks | Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. Percentage of participants free from complications are reported |
| Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range | 6 Weeks (Aveir VR Leadless Pacemaker arm) | Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes, which are defined as pacing threshold \<=2.0V at 0.4 ms pulse width and R-wave amplitude =\>5.0 mV or =\> value at implant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appropriate and Proportional Rate Response During Graded Exercise Testing | 3 month follow up | Temperature-based rate response feature was evaluated to determine whether an appropriate and proportional rate response was achieved during maximal effort graded treadmill exercise testing protocol (CAEP). Subjects were asked to perform a six-minute walk test to identify optimal sensor parameters prior to conducting a CAEP test. Exercise test data provide an estimate of the slope of the normalized increase in sensor-indicated rate versus normalized workload for each subject. Normalizing a variable eliminates the unit. Since both axes are normalized, there is no unit of measure. The vertical axis is derived from the difference of the sensor indicated rate at each exercise stage and the base rate, divided by the difference of the age-predicted maximum heart rate and base rate. Values on the horizontal axis are derived from the difference in the workload at each exercise stage and resting workload, divided by the difference of the maximum achieved workload and resting workload. |
| Survival Rate of Patients Implanted With the Nanostim Leadless Pacemaker | 2 years | All-Cause Mortality through 2 years among subjects implanted with the Nanostim Leadless Pacemaker. The Nanostim Leadless Pacemaker is functionally similar to the Aveir VR Leadless Pacemaker, and was evaluated in The LEADLESS II IDE Study (Phase I) - NCT02030418. For detailed demographic and study information including adverse events, refer to NCT02030418 |
Countries
Canada, Czechia, France, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORNicole Harbert
Abbott
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 75.6 Years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 230 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 82 Participants |
| Pacemaker Indication Chronic AF with 2nd or 3rd Degree AV Block or Bundle Branch Block, including slow ventricular rates | 165 Participants |
| Pacemaker Indication Sinus Bradycardia with Infrequent Pauses or Unexplained Syncope | 94 Participants |
| Pacemaker Indication Sinus Rhythm with 2nd or 3rd Degree AV Block or Bundle Branch Block | 65 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants |
| Race/Ethnicity, Customized Declined or Unable to Disclose Due to Local Regulation | 73 Participants |
| Race/Ethnicity, Customized Other | 4 Participants |
| Race/Ethnicity, Customized Unknown | 4 Participants |
| Race/Ethnicity, Customized White or Caucasian | 233 Participants |
| Region of Enrollment Canada | 82 Participants |
| Region of Enrollment Czechia | 24 Participants |
| Region of Enrollment France | 11 Participants |
| Region of Enrollment Italy | 4 Participants |
| Region of Enrollment Netherlands | 5 Participants |
| Region of Enrollment Spain | 27 Participants |
| Region of Enrollment United Kingdom | 2 Participants |
| Region of Enrollment United States | 169 Participants |
| Sex: Female, Male Female | 123 Participants |
| Sex: Female, Male Male | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 31 / 324 |
| other Total, other adverse events | 60 / 324 |
| serious Total, serious adverse events | 98 / 324 |
Outcome results
None listed