BIOTRONIK Conduction System Pacing with the Solia Lead (BIO-CONDUCT)

Biotronik

Status

Completed

Conditions

Bradycardia

Atrioventricular Block

Left Bundle-Branch Block

Cardiomyopathies

Treatments

Device: Solia S lead

Study type

Interventional

Funder types

Industry

Identifiers

NCT05251363

G210349

Details and patient eligibility

About

The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area. 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.

Enrollment

186 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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 LBB area
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