Who is sponsoring NCT06620237?

NCT06620237 is sponsored by Biotronik SE & Co. KG.

What condition does NCT06620237 study?

NCT06620237 studies Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia, Conduction Disorder, Conduction Defect, Cardiac, Heart Failure.

What drugs are being tested in NCT06620237?

Interventions: Implantation of the Solia CSP S pacing lead for LBBAP.

What is the status of NCT06620237?

NCT06620237 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2025-11-17 · How we verify

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

NCT06620237 NA ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Biotronik SE & Co. KG
Phase	NA
Status	ACTIVE_NOT_RECRUITING
Enrolment	152
Start date	2024-10-04
Completion	2027-09

Conditions

Cardiac Pacing, Artificial
Cardiac Pacemaker, Artificial
Cardiac Resynchronization Therapy Devices
Bradycardia
Conduction Disorder
Conduction Defect, Cardiac
Heart Failure

Interventions

Implantation of the Solia CSP S pacing lead for LBBAP

Primary outcomes

Amvia related SADE-d free rate — 6 months (183 days) after implantation
rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker
Solia CSP S related SADE-d free rate — 6 months (183 days) after implantation
rate of serious adverse device effects possible, probable or causal related to the Solia CSP S lead

Countries

Australia, Belgium, France, Netherlands, New Zealand