Patients with a class I or II indication for VVI/VDD according to applicable guidelines.
Conditions
Interventions
BLP-3231 system implantation via femoral vein.
Sponsors
Ota Masaya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Class I or Class II indication for ventricular pacing (VVI/VDD) according to applicable guidelines 2. Age is greater than or equal to 18 years at time of consent 3. Able to understand the nature of the study and provide written informed consent 4. Able and willing to complete all study requirements, including completion of all planned in-office study visits, for the expected duration of follow-up
Exclusion criteria
Exclusion criteria: 1. AV block with a ventricular escape rhythm less than or equal to 30 bpm at time of consent Note: Restriction removed after early safety phase objectives are met 2. Femoral venous anatomy that is unable to accommodate the introducer or the cardiac anatomy does not allow a leadless pacemaker in the right ventricle 3. Morbid obesity which may prevent the BLP-3231 device from obtaining telemetry communication within a range of 20 cm, in the physicians judgement 4. Intolerance to dexamethasone acetate 5. Other implanted devices that, in the judgement of the implanting physician, could interfere (mechanically or electrically) with the leadless pacemaker or with the implant procedure 6. Allergy to the materials of the leadless pacemaker or the implant tools that are in contact with the human body 7. Prior leadless pacemaker implant attempt 8. Existing transvenous or leadless pacemaker, transvenous or subcutaneous ICD, or CRT device or previous extraction in which transvenous leads (full or partial) were left in the heart Note: Exception given to use temporary transvenous pacemakers 9. CIED device extraction within the previous 72 hours or signs of active infection after CIED extraction Note: Patients with extraction due to potential systemic infection must have a blood culture. A blood culture is considered negative if there is no growth within 72 hours of BLP-3231 device implant. 10. Planned ICD or CRT device implant 11. Unstable angina or acute myocardial infarction within 30 days prior to enrollment 12. Life expectancy of less than 12 months 13. Unable to tolerate an urgent sternotomy 14. Planned right-sided heart intervention within 30 days after implant Note: Exception given to AV nodal ablations when performed by an implanting investigator once early safety phase objectives are met 15. Listed for or has received a heart transplantation or has a left ventricular assist device (LVAD) 16. Participation or plans to participate in any other potentially confounding investigational drug or device trial, or any other clinical trial that may interfere with this studys treatment or protocol during the duration of the study1,2 Note: Co-enrollment in concurrent trials is only allowed when documented prior approval is obtained from BIOTRONIK 17. Unable to attend in-person planned or emergent study site visits (e.g., frequent or extended travel plans) 18. Pregnant or plan to become pregnant during the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objectives: 1. Freedom from SADEs related to the BLP-3231 system and/or procedure through 3-month follow-up 2. Adequate and stable pacing measured at the 3-month follow-up visit 3. Combination of adequate pacing and sensing measured at the 3-month follow-up visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: 1. Improvement in SF-36 role physical scale from baseline to the 6-month follow-up visit 2. Accuracy of ventricular capture control algorithm-determined pacing thresholds at the 3-month follow-up visit 3. Adequate rate response operation at the 3-month follow-up visit 4. Freedom from SADEs (time to first SADE) related to the BLP-3231 system and/or procedure through 3-, 6- and 12 months follow-up 5. Adequate and stable pacing at the 6- and 12-month follow-up visits 6. Combination of adequate pacing and sensing at the 6- and 12-month follow-up visits 7. Changes in health-related quality of life via EQ-5D-5L questionnaire from baseline to 3- and 6-month follow-up visits 8. Changes in health-related quality of life via SF-36 questionnaire from baseline to 3- and 6-month follow-up visits 9. Projected BLP-3231 device battery longevity estimates at the 12-month follow-up visit 10. Survival assessment through 2 years | — |
Countries
Australia, Austria, Belgium, France, Germany, Japan, Netherlands, USA
Contacts
Public ContactYuki Mizukami
BIOTRONIK Japan, Inc.
Outcome results
None listed