Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker. Following completion of enrollments in the IDE, patients will continue to be enrolled in the continued access phase of the study under the same protocol.
The purpose of this study is to evaluate the safety and effectiveness of the leadless pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in battery and electrodes, for permanent implantation in the right ventricle. As a leadless pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has the same operating principles as a conventional pacemaker.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
952
Patients will undergo an attempted leadless pacemaker implant
Complication-Free Rate
Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Percentage of participants free from complications are reported
Time frame: 6 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 either =\>5.0 mV at the 6 month visit or =\> value at implant.
Time frame: 6 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). All capable subjects who have completed the 6-minute walk test (6MWT) were asked to perform a maximal effort CAEP exercise protocol to demonstrate an appropriate and proportional response of sensor-indicated rate in graded exercise tests. Data from subjects who have completed the 6MWT and have completed at least stage 3 of the CAEP exercise protocol, or 3.6 metabolic equivalent of task (METs), were included in the analysis.
Time frame: 3-6 months
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University Hospital - Univ. of Alabama at Birmingham
Birmingham, Alabama, United States
Heart Center Research, LLC.
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Scripps Health
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