Pivotal Study of the Amvia Pacemaker and Solia CSP S Pacing Lead on Conduction System Pacing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Biotronik SE & Co. KG
- Enrollment
- 152
- Locations
- 14
- Primary Endpoint
- Solia CSP S related SADE-d free rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
LBBAP Amvia
All patients with successful implantation of Amvia pacemaker and a lead in a position intended for LBBA pacing.
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.
Intervention: Implantation of the Solia CSP S pacing lead for LBBAP (Device)
Outcomes
Primary Outcomes
Solia CSP S related SADE-d free rate
Time Frame: 6 months (183 days) after implantation
rate of serious adverse device effects possible, probable or causal related to the Solia CSP S lead
Amvia related SADE-d free rate
Time Frame: 6 months (183 days) after implantation
rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker
Secondary Outcomes
- Amvia related SADE-d free rate(12 months (365 days) after implantation)
- Solia CSP S related SADE-d free rate(12 months (365 days) after implantation)
- Rate of successful acute CSP implantation of Solia CSP S(At the day of implantation)
- Sensing performance(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)
- Pacing performance(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)
- Physiologic ventricular excitation(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)
- Mid-term change in LVEF(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)
- Mid-term change in LVESV(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)
- Mid-term change in quality of life, EQ-5D-5L (EuroQol) questionnaire(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)
- Mid-term change in quality of life, SF-36 (Short Form Health Survey) questionnaire(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)