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

Biotronik

Status: Active, not recruiting

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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186 participants in 1 patient group

Solia S LBB lead

Other group

Treatment:

Device: Solia S lead