BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S
- Conditions
- Sinus Node DysfunctionBradycardiaAtrioventricular Block
- Registration Number
- NCT06540079
- Lead Sponsor
- Biotronik, Inc.
- Brief Summary
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA). Safety will be assessed by evaluating serious adverse device effects that occur through 3 months post-implant. Efficacy will be assessed by evaluating implant success rate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
- Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and CRT-P systems are allowed.
- Patient has an implant planned to utilize left bundle branch area (LBBA) pacing within 30 days of consent
- Patient is able to understand the nature of the study and provide written informed consent
- Patient is available for follow-up visits on a regular basis for the expected duration of follow-up
- Patient accepts Home Monitoring® concept
- Patient age is greater than or equal to 18 years at time of consent
- Patient meets a standard contraindication for pacemaker system implant
- Patient is currently implanted with a pacemaker or ICD device
- Patient has had a previous unsuccessful attempt to place a lead in the LBBA
- Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
- Patient is expected to receive a heart transplant within 12 months
- Patient life expectancy less than 12 months
- Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
- Patient reports pregnancy at the time of enrollment
- Patient is enrolled in any other investigational cardiac clinical study during the course of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Serious Adverse Device Effect (SADE)-Free Rate at 3 Months 3 months post-implant Serious adverse device effect includes both serious lead related and serious implant related device effects. The overall percentage of subjects without serious lead related adverse device effects related to Solia CSP S lead utilized or attempted to be implanted in the LBBA and serious implant procedure events related to the Solia CSP S LBBA lead will be reported.
Implant Success Rate At implant procedure The overall percentage of subjects with successful placement of Solia CSP S lead in LBBA will be reported.
- Secondary Outcome Measures
Name Time Method Pacing Impedance at 6 Months 6 months post-implant Pacing impedance measurements for Solia CSP S leads implanted in the LBBA at the 6 month follow-up visit.
Pacing Threshold Measurements at 12 Months 12 months post-implant Pacing threshold measurements for Solia CSP S leads implanted in the LBBA at the 12 month follow-up visit.
Sensing Measurements at 12 Months 12 months post-implant R-wave sensing amplitude measurements for Solia CSP S leads implanted in the LBBA at the 12 month follow-up visit.
Pacing Impedance at 12 Months 12 months post-implant Pacing impedance measurements for Solia CSP S leads implanted in the LBBA at the 12 month follow-up visit.
Quality of Life (QOL) from Baseline through 12 Months Post-Implant 12 months post-implant This secondary outcome will evaluate the improvement in QOL for subjects with the Solia CSP S lead implanted in the LBBA. The parameter of interest is the change in the physical function SF-36 (36-Item Short Form Health Survey) QOL scale from pre-implant baseline to 12 months post-implant, which will be calculated as the mean change from baseline for all subjects that complete both the baseline QOL and 12-month QOL questionnaire. Note that all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Serious Adverse Device Effect (SADE)-Free Rate at 6 Months 6 months post-implant Serious adverse device effect includes both serious lead related and serious implant related device effects. The overall percentage of subjects without serious lead related adverse device effects related to Solia CSP S lead utilized or attempted to be implanted in the LBBA and serious implant procedure events related to the Solia CSP S LBBA lead will be reported.
Serious Adverse Device Effect (SADE)-Free Rate at 12 Months 12 months post-implant Serious adverse device effect includes both serious lead related and serious implant related device effects. The overall percentage of subjects without serious lead related adverse device effects related to Solia CSP S lead utilized or attempted to be implanted in the LBBA and serious implant procedure events related to the Solia CSP S LBBA lead will be reported.
Pacing Threshold Measurements at 3 Months 3 months post-implant Pacing threshold measurements for Solia CSP S leads implanted in the LBBA at the 3 month follow-up visit.
Sensing Measurements at 3 Months 3 months post-implant R-wave sensing amplitude measurements for Solia CSP S leads implanted in the LBBA at the 3 month follow-up visit.
Pacing Impedance at 3 Months 3 months post-implant Pacing impedance measurements for Solia CSP S leads implanted in the LBBA at the 3 month follow-up visit.
Pacing Threshold Measurements at 6 Months 6 months post-implant Pacing threshold measurements for Solia CSP S leads implanted in the LBBA at the 6 month follow-up visit.
Sensing Measurements at 6 Months 6 months post-implant R-wave sensing amplitude measurements for Solia CSP S leads implanted in the LBBA at the 6 month follow-up visit.
Trial Locations
- Locations (10)
Cardiology Associates Medical Group
🇺🇸Ventura, California, United States
Banner - University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Cardiology Associates Research, LLC
🇺🇸Tupelo, Mississippi, United States
NYU Heart Rhythm Center
🇺🇸New York, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Atrium Health Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Cardiology Consultants of Philadelphia
🇺🇸Paoli, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States