BIOTRONIK Conduction System Pacing With the Solia Lead

Not Applicable

Completed

Conditions: Bradycardia
Atrioventricular Block
Left Bundle-Branch Block
Cardiomyopathies

Interventions: Device: Solia S lead

Registration Number: NCT05251363

Lead Sponsor: Biotronik, Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 194

Inclusion Criteria

Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and Cardiac Resynchronization Therapy with a Pacemaker (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 Implantable Cardioverter-Defibrillator (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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Solia S LBB lead	Solia S lead	-

Primary Outcome Measures

Name	Time	Method
Serious Adverse Device Effect (SADE)-Free Rate at 3 Months	3 months post implant	The overall rate of serious Solia S Left Bundle Branch (LBB) lead related adverse device effects and serious implant procedure events related to the Solia S LBB lead that occur through 3 months post-implant. The definition of adverse device effect is an untoward medical occurrence (e.g. disease, injury) related to the use of a study device. Pacemaker lead-related examples include events such as lead dislodgements or lead malfunction. The Solia S LBB lead complication-free rate is calculated as the number of subjects without one or more adverse device effect complications divided by the total number of study subjects successfully enrolled and subjects undergoing an unsuccessful implant attempt who have a qualifying primary safety endpoint event. Classification of adverse device related events from the pool of potential events is determined by a clinical events committee (CEC). The complication-free rate is expressed in percent.
Implant Success Rate of the Solia S Lead in LBB Area	at implant procedure	The percentage of subjects with Solia S placed successfully in the LBBA divided by the total number of consented study subjects in whom an implant of Solia S in the LBBA was attempted.

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QOL) From Baseline Through 12 Months Post-Implant	12 months post implant	The change in the physical function Short Form-36 (SF-36, 36-Item Short Form Health Survey) QOL subscale was calculated as the mean change from baseline to 12-month follow-up for all subjects that completed both the baseline QOL and 12-month QOL questionnaire. The physical function subscale of Short Form-36 is comprised of ten questions out of the total of 36 questions. The responses to the ten questions relating to physical function were averaged at baseline and at 12 months. The difference in the averages (12 months minus baseline) is reported as the outcome for secondary endpoint 1. Note that each question and each component is scored such that a higher score defines a more favorable health state. Each is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Sensing Measurements for Solia S Lead at 3 Months	3 months post implant	R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.
Pacing Impedance for Solia S Lead at 3 Months	3 months post implant	Pacing impedance measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.
Pacing Threshold Measurements for Solia S Lead at 6 Months	6 months post implant	Pacing threshold measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.
Sensing Measurements for Solia S Lead at 6 Months	6 months post implant	R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.
Pacing Impedance for Solia S Lead at 6 Months	6 months post implant	Pacing impedance measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.
Pacing Threshold Measurements for Solia S Lead at 12 Months	12 months post implant	Pacing threshold measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.
Sensing Measurements for Solia S Lead at 12 Months	12 months post implant	R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.
Serious Adverse Device Effect (SADE)-Free Rate at 6 Months	6 months post implant	The overall rate of serious Solia S LBBA lead related adverse device effects and serious implant procedure events related to the Solia S LBBA lead that occur through 6 months post-implant. The Solia S LBBA lead complication-free rate per subject, which was calculated as the number of subjects without one or more complications divided by the total number of study subjects successfully enrolled and subjects undergoing an unsuccessful implant attempt who have a qualifying safety endpoint event. The complication-free rate is expressed in percentage of participants without SADE.
Serious Adverse Device Effect (SADE)-Free Rate at 12 Months	12 months post implant	The overall rate of serious Solia S LBBA lead related adverse device effects and serious implant procedure events related to the Solia S LBBA lead that occur through 12 months post-implant. The Solia S LBBA lead complication-free rate per subject, which was calculated as the number of subjects without one or more complications divided by the total number of study subjects successfully enrolled and subjects undergoing an unsuccessful implant attempt who have a qualifying safety endpoint event. The complication-free rate is expressed in percent.
Pacing Threshold Measurements for Solia S Lead at 3 Months	3 months post implant	Pacing threshold measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.
Pacing Impedance for Solia S Lead at 12 Months	12 months post implant	Pacing impedance measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.

Trial Locations

Locations (14): Cardiology Associates Medical Group
🇺🇸
Ventura, California, United States
Cardiology Consultants of Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States
Geisinger
🇺🇸
Wilkes-Barre, Pennsylvania, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
University of Chicago
🇺🇸
Chicago, Illinois, United States
Cardiology Associates
🇺🇸
Tupelo, Mississippi, United States
Tampa General Hospital
🇺🇸
Tampa, Florida, United States
Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Weill Cornell Medicine
🇺🇸
New York, New York, United States
Medical University of South Carolina (MUSC)
🇺🇸
Charleston, South Carolina, United States
Banner - University Medical Center Phoenix
🇺🇸
Phoenix, Arizona, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Sarasota Memorial Health Care System
🇺🇸
Sarasota, Florida, United States
NYU Langone Health
🇺🇸
New York, New York, United States