BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S

BIOTRONIK Conduction System Pacing With the Solia Lead

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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