Pivotal Study of the Amvia Pacemaker and Solia CSP S Pacing Lead on Conduction System Pacing

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP). The patient population consist of patients with cardiac pacemaker indication or cardiac resynchronization therapy indication and intended for implantation of a system with left bundle branch area stimulation. Participants will visit sites at enrollment in the study, at implantation and pre-hospital discharge, 1-, 6- and 12-month follow-up visits. Additional annual follow-up(s) may apply until study termination after regulatory approval of Solia CSP S. The total duration of the clinical investigation is expected to be until September 2027, with last patient out (LPO). During the visits the regular pacemaker and lead measurement are performed. A 12-lead ECG is recorded to document intrinsic and ventricularly paced heart rhythm to assess left bundle branch area pacing. Programming of the pacemakers will be done according to the participant´s therapeutical needs. The study will be conducted in approximately 18 sites in Europe, Australia and New Zealand where more than one physician per site are expected to participate.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Contact Information
Primary
Mathias Freudigmann
mathias.freudigmann@biotronik.com
+49 30 68905
Backup
Torsten Kallert
torsten.kallert@biotronik.com
+49 30 68905
Time Frame
Start Date: 2024-10-04
Estimated Completion Date: 2027-09
Participants
Target number of participants: 152
Treatments
No_intervention: LBBAP Amvia
All patients with successful implantation of Amvia pacemaker and a lead in a position intended for LBBA pacing.
Experimental: LBBAP Solia CSP S
All patients with successful implantation of a Solia CSP S lead in LBB area. Additionally, all patients with a non-successful Solia CSP S implantation attempt in which an ADE (adverse device effect) or SADE (serious adverse device effect) related to the Solia CSP S lead occurred.
Related Therapeutic Areas
Sponsors
Leads: Biotronik SE & Co. KG

This content was sourced from clinicaltrials.gov