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

Biotronik, Inc.220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Sinus Node Dysfunction Bradycardia Atrioventricular Block

Interventions

Solia CSP S leadDEVICE

The Solia CSP S pacing lead will be implanted in the LBBA for patients who meet all inclusion/exclusion criteria and give written informed consent.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Banner - University Medical Center Phoenix

Phoenix, Arizona, United States

RECRUITING

Cardiology Associates Medical Group

Ventura, California, United States

RECRUITING

Outcomes

Primary Outcomes

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 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.

Time frame: 3 months post-implant

Implant Success Rate

The overall percentage of subjects with successful placement of Solia CSP S lead in LBBA will be reported.

Time frame: At implant procedure

Secondary Outcomes

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 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.

Time frame: 12 months post-implant

Serious Adverse Device Effect (SADE)-Free Rate at 6 Months

Time frame: 6 months post-implant

Serious Adverse Device Effect (SADE)-Free Rate at 12 Months

Central Contacts

Justin Michalski

CONTACT

1-800-547-0394 bio-conduct@biotronik.com

Data from ClinicalTrials.gov

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