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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,276
Patients will undergo an attempted leadless pacemaker implant
Complication-Free Rate (CFR)
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
Time frame: 6 weeks
Complication-Free Rate (CFR)
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. The complication free rate reported describes the Kaplan-Meier estimate of the percentage of patients that had no complications at the given time point.
Time frame: 12 months
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range
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.
Time frame: 6 Weeks (Aveir VR Leadless Pacemaker arm)
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range
Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes at 12-Month post-implant visit, 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.
Time frame: 12 months
Appropriate and Proportional Rate Response During Graded Exercise Testing
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.
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University Hospital - University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
The Heart Center PC
Huntsville, Alabama, United States
Honor Health
Scottsdale, Arizona, United States
University of Southern California
Long Beach, California, United States
Premier Cardiology Inc
Newport Beach, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
South Denver Cardiology Associates PC
Littleton, Colorado, United States
Naples Heart Rhythm Specialists PA
Naples, Florida, United States
Orlando Health
Orlando, Florida, United States
Piedmont Athens Regional Medical Center
Athens, Georgia, United States
...and 43 more locations
Time frame: 3 month follow up
Survival Rate of Patients Implanted With the Nanostim Leadless Pacemaker
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
Time frame: 2 years