Clinical trial NCT06620237: BIO|MASTER.CSP Study
Official title: Pivotal Study of the Amvia Pacemaker and Solia CSP S Pacing Lead on Conduction System Pacing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Pacing, Artificial
Cardiac Pacemaker, Artificial
Cardiac Resynchronization Therapy Devices
Bradycardia
Conduction Disorder
Conduction Defect, Cardiac
Heart Failure
Keywords: Conduction system pacing (CSP)
Left bundle branch area pacing (LBBAP)
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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)

Primary outcomes:
measure: Amvia related SADE-d free rate
timeFrame: 6 months (183 days) after implantation
measure: Solia CSP S related SADE-d free rate
timeFrame: 6 months (183 days) after implantation
Secondary outcomes:
measure: Amvia related SADE-d free rate
timeFrame: 12 months (365 days) after implantation
measure: Solia CSP S related SADE-d free rate
timeFrame: 12 months (365 days) after implantation
measure: Rate of successful acute CSP implantation of Solia CSP S
timeFrame: At the day of implantation
measure: Sensing performance
timeFrame: At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section
measure: Pacing performance
timeFrame: At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section
measure: Physiologic ventricular excitation
timeFrame: At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section
measure: Mid-term change in LVEF
timeFrame: At baseline, at the 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
measure: Mid-term change in LVESV
timeFrame: At baseline, at the 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
measure: Mid-term change in quality of life, EQ-5D-5L (EuroQol) questionnaire
timeFrame: At baseline after patient enrollment prior to implantation, at the date of 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
measure: Mid-term change in quality of life, SF-36 (Short Form Health Survey) questionnaire
timeFrame: At baseline after patient enrollment prior to implantation, at the date of 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: University Hospital Ghent, Gent (Belgium)
name: Jan De Pooter, MD, PhD
role: STUDY_CHAIR
References: