BIOTRONIK Conduction System Pacing With the Solia Lead

Study Overview
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Brief Summary
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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.

Official Title
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BIOTRONIK Conduction System Pacing With the Solia Lead

Conditions
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Bradycardia, Atrioventricular Block, Left Bundle-Branch Block, Cardiomyopathies

Intervention / Treatment
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* Device: Solia S lead


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Solia S LBB lead<br> | Device: Solia S lead<br>* The Solia S pacing lead will be implanted in the LBB area for patients who meet all inclusion/exclusion criteria and give written informed consent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse device effect (SADE)-free rate at 3 months | 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 S lead utilized or attempted to be implanted in the LBB area and serious implant procedure events related to the Solia S LBB lead will be reported. | 3 months post implant | 
| Implant Success rate of the Solia S lead in LBB area | The overall percentage of subjects with successful placement of Solia S lead in LBB area. | at implant procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QOL) from baseline through 12 Months Post-Implant | This secondary outcome will evaluate the improvement in QOL for subjects with the Solia S lead implanted in the left bundle branch (LBB) area. 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. | 12 months post implant | 
| Serious adverse device effect (SADE)-free rate at 6 months | 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 S lead utilized or attempted to be implanted in the LBB area and serious implant procedure events related to the Solia S LBB lead will be reported. | 6 months post implant | 
| Serious adverse device effect (SADE)-free rate at 12 months | 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 S lead utilized or attempted to be implanted in the LBB area and serious implant procedure events related to the Solia S LBB lead will be reported. | 12 months post implant | 
| Pacing threshold measurements for Solia S lead at 3 months | Pacing threshold measurements for Solia S leads implanted in the LBB area at the 3 month follow-up visit. | 3 months post implant | 
| Sensing measurements for Solia S lead at 3 months | R-wave sensing amplitude measurements for Solia S leads implanted in the LBB area at the 3 month follow-up visit. | 3 months post implant | 
| Pacing impedance for Solia S lead at 3 months | Pacing impedance measurements for Solia S leads implanted in the LBB area at the 3 month follow-up visit. | 3 months post implant | 
| Pacing threshold measurements for Solia S lead at 6 months | Pacing threshold measurements for Solia S leads implanted in the LBB area at the 6 month follow-up visit. | 6 months post implant | 
| Sensing measurements for Solia S lead at 6 months | R-wave sensing amplitude measurements for Solia S leads implanted in the LBB area at the 6 month follow-up visit. | 6 months post implant | 
| Pacing impedance for Solia S lead at 6 months | Pacing impedance measurements for Solia S leads implanted in the LBB area at the 6 month follow-up visit. | 6 months post implant | 
| Pacing threshold measurements for Solia S lead at 12 months | Pacing threshold measurements for Solia S leads implanted in the LBB area at the 12 month follow-up visit. | 12 months post implant | 
| Sensing measurements for Solia S lead at 12 months | R-wave sensing amplitude measurements for Solia S leads implanted in the LBB area at the 12 month follow-up visit. | 12 months post implant | 
| Pacing impedance for Solia S lead at 12 months | Pacing impedance measurements for Solia S leads implanted in the LBB area at the 12 month follow-up visit. | 12 months post implant |