Bradycardia, Cardiac Pacemaker, Artificial, Cardiac Pacing, Artificial, Cardiac Resynchronization Therapy Devices, Conduction Defect, Cardiac, Conduction Disorder, Heart Failure
Conditions
Keywords
Conduction system pacing (CSP), Left bundle branch area pacing (LBBAP)
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.
Interventions
Left bundle branch area pacing using a Solia CSP S lead
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful acute CSP implantation of Solia CSP S | At the day of implantation | All implantations, in which the investigator decides to leave the Solia CSP S pacing lead permanently in the conduction system, are counted as acute success. |
| 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 | Investigators will be asked whether the sensing is adequate (yes/no decision) |
| 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 | Investigators will be asked whether the pacing is adequate (yes/no decision) |
| 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 | Investigators are asked to assess whether pacing in the left bundle branch area is still present based on the 12-lead ECG recording |
| Amvia related SADE-d free rate | 12 months (365 days) after implantation | Rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker |
| 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 | Collection of left ventricular ejection systolic volume (LVESV) values |
| 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 | Collection of health-related quality of life questionnaires from the patient to monitor mid-term changes in the quality of life, analysis and reporting according to EuroQol methodology |
| 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 | Collection of health-related quality of life questionnaires from the patient to monitor mid-term changes in the quality of life, analysis and reporting according to item short form health survey (SF-36) standard methodology |
| 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 | Collection of left ventricular ejection fraction (LVEF) values |
| Solia CSP S related SADE-d free rate | 12 months (365 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
Outcome results
None listed