Testing a new pacemaker for heart rhythm management
Pivotal Study of the Amvia Pacemaker and Solia CSP S Pacing Lead on Conduction System Pacing
This study is testing a new type of pacemaker to see if it safely helps people with heart rhythm issues who need a pacemaker.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biotronik SE & Co. KG Industry-sponsored |
| Locations | 1 site (Auckland) |
| Trial ID | NCT06620237 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the safety and performance of the Amvia pacemakers and Solia CSP S lead specifically for left bundle branch area pacing (LBBAP). Patients who require a pacemaker or cardiac resynchronization therapy will be enrolled and monitored through various follow-up visits, including assessments of heart rhythm and device performance. The study will continue until September 2027, with regular evaluations to ensure the effectiveness of the pacing system. Participants will also utilize the CardioMessenger for home monitoring.
Who should consider this trial
Good fit: Ideal candidates include patients with a standard indication for pacemaker implantation or cardiac resynchronization therapy who are suitable for left bundle branch area stimulation.
Not a fit: Patients who are expected to undergo other cardiac surgical procedures or have a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve heart rhythm management for patients requiring pacemakers, potentially leading to better outcomes and quality of life.
How similar studies have performed: While this approach is relatively novel, similar studies have shown promise in improving pacing techniques and patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: For patient enrollment in the study all of the following inclusion criteria have to be fulfilled at the time of enrollment: * Standard indication for de novo pacemaker implantation or cardiac resynchronization therapy (CRT) * Patient is intended for implantation of a pacemaker or CRT-P system with left bundle branch area stimulation * Ability to understand the nature of the study * Ability and willingness to perform all follow-up visits at the study site * Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept Exclusion Criteria: Enrollment of a patient is not permitted if at least one of the following criteria is fulfilled: * Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months * Expected to receive heart transplantation or ventricular assist device within 12 months * Life-expectancy less than 12 months * Pregnant or breast feeding * Age less than 18 years * Participation in another interventional clinical investigation (according to the definition given in the CIP)
Where this trial is running
Auckland
- Auckland City Hospital — Auckland, New Zealand (Recruiting)
Study contacts
- Study coordinator: Mathias Freudigmann
- Email: mathias.freudigmann@biotronik.com
- Phone: +49 30 68905
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.