BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
Condition(s) studied
Investigational drug(s) / intervention(s)
LivIQ Leadless Pacemaker System: Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.
Study summary
The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI/VDD) according to applicable guidelines. An integrated atrioventricular synchrony sub-study (AVS) is specifically designed to evaluate the AVS performance of the LivIQ system.
Eligibility
Primary outcome measure(s)
- Freedom from Serious Adverse Device Effects — 3 months
Demonstrate that the freedom from SADEs related to the LivIQ system and/or procedure through 3-month follow-up exceeds the performance goal. - Percentage of Subjects with Adequate Pacing — 3 months
Demonstrate that the percentage of subjects with adequate and stable pacing at the 3-month follow-up visit exceeds the performance goal. - Percentage of Subjects with Adequate Pacing and Sensing — 3 months
Demonstrate that the percentage of subjects with adequate pacing and sensing at the 3-month follow-up visit exceeds the performance goal.
Trial sites (43)
| Facility | City | Region | Status |
|---|---|---|---|
| Sutter Health | Burlingame | California | Recruiting |
| UC San Diego Health | La Jolla | California | Recruiting |
| MemorialCare Saddleback Medical | Laguna Hills | California | Recruiting |
| Cardiology Associates Medical Group | Ventura | California | Recruiting |
| South Denver Cardiology | Littleton | Colorado | Recruiting |
| Orlando Health Heart & Vascular Institute | Orlando | Florida | Recruiting |
| Sarasota Memorial Health Care System | Sarasota | Florida | Recruiting |
| Baptist Health Lexington | Lexington | Kentucky | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| Trinity Health Michigan Heart | Ypsilanti | Michigan | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| Washington University | St Louis | Missouri | Recruiting |
| NYU Heart Rhythm Center | New York | New York | Recruiting |
| NY Presbyterian Weill Cornell Medicine | New York | New York | Recruiting |
| Montefiore Medical Center - Moses Division | The Bronx | New York | Recruiting |
| Advocate/Atrium Health Sanger Heart and Vascular Institute | Charlotte | North Carolina | Recruiting |
| WakeMed | Raleigh | North Carolina | Recruiting |
| Wake Forest University Health | Winston-Salem | North Carolina | Recruiting |
| Cardiology Consultants of Philadelphia | Paoli | Pennsylvania | Recruiting |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | Recruiting |
| WellSpan Health York Hospital | York | Pennsylvania | Recruiting |
| UVA Health University Medical Center | Charlottesville | Virginia | Recruiting |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | Recruiting |
| Princess Alexandra Hospital | Woolloongabba | Queensland | Recruiting |
| Royal Adelaide Hospital | Adelaide | South Australia | Recruiting |
| Victorian Heart Hospital | Clayton | Victoria | Recruiting |
| Kepler Universitätsklinikum GmbH | Linz | Austria | Recruiting |
| AZ Sint-Jan | Bruges | Belgium | Recruiting |
| Jessa Ziekenhuis | Hasselt | Belgium | Recruiting |
| UZ Leuven Gasthuisberg | Leuven | Belgium | Recruiting |
| CHR de la Citadelle - Liège | Liège | Belgium | Recruiting |
| Hôpital Gabriel Montpied, Clermont Ferrand | Clermont-Ferrand | France | Recruiting |
| Hôpital Europeén Georges Pompidou | Paris | France | Recruiting |
| Hôpital Haut Lévêque (CHU) | Pessac | France | Recruiting |
| Kerckhoff-Klinik GmbH | Bad Nauheim | Hesse | Recruiting |
| Herz- und Diabeteszentrum NRW | Bad Oeynhausen | North Rhine-Westphalia | Recruiting |
| Heinrich-Heine Universität Düsseldorf | Düsseldorf | Germany | Recruiting |
| Kokura Memorial Hospital | Kitakyushu | Fukuoka | Active Not Recruiting |
| National Cerebral and Cardiovascular Center Hospital | Suita | Osaka | Active Not Recruiting |
+ 3 more sites — see the full list on the official registry below.
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07118358 on ClinicalTrials.gov ↗ ← All trials in the USA