Bradycardia slow heartbeat
Conditions
Interventions
LivIQ VR-T DX Leadless Pacemaker (pre-mounted on the Delivery Catheter)LivIQ Introducer (referred to as ‘introducer kit’) 
Renamic Neo Programmer Software NEO 2505.A/S
Sponsors
BIOTRONIK SE & Co. KG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient meets Class I or Class II indication for ventricular pacing (VVI/VDD) according to applicable guidelines.Age 18 years or older at time of Informed consent.Patient is able to understand the nature of the study and able to provide written informed consent.Patient is able and willing to complete all study requirements including completion of all planned in-office study visits, for the expected duration of follow-up.
Exclusion criteria
Exclusion criteria: AV block with a ventricular escape rhythm = 30 bpm at time of consent (restriction removed after early assessment objectives are met).Femoral venous anatomy that is unable to accommodate the introducer or the cardiac anatomy does not allow a leadless pacemaker in the right ventricle.Morbid obesity which may prevent the LivIQ device from obtaining telemetry communication within a range of 20 cm, in the physician’s judgement.see CIP paragraph 9.1.2 for more exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from SADEs (time to first SADE) related to the LivIQ system and/or procedure through 3-month follow-up. Adequate and stable pacing measured at the 3-month follow-up visit. Combination of adequate pacing and sensing measured at the 3- month follow-up visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in SF-36 role physical scale from baseline to the 6- month follow-up visit Accuracy of ventricular capture control algorithm-determined pacing thresholds at the 3-month follow-up visit Adequate rate response operation at the 3-month follow-up visit Freedom from SADEs (time to first SADE) related to the LivIQ system and/or procedure through 3-, 6- and 12 months Adequate and stable pacing at the 6- and 12-month follow-up visits Combination of adequate pacing and sensing at the 6- and 12- month follow-up visits Changes in health-related quality of life via EQ-5D-5L questionnaire from baseline to 3- and 6-month follow-up visits Changes in health-related quality of life via SF-36 questionnaire from baseline to 3- and 6-month follow-up visits Projected LivIQ battery longevity estimates at the 12-month follow-up visit Survival assessment through 2 years | — |
Countries
Australia, Austria, Belgium, France, Germany, Japan, Netherlands, United States
Contacts
Public ContactMathias Freudigmann
BIOTRONIK SE & Co. KG
Outcome results
None listed