BIOTRONIK Conduction System Pacing With the Solia Lead

Biotronik, Inc.194 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

194

Conditions

Bradycardia Atrioventricular Block Left Bundle-Branch Block Cardiomyopathies

Interventions

Solia S leadDEVICE

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.

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 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

Locations (14)

Banner - University Medical Center Phoenix

Phoenix, Arizona, United States

Cardiology Associates Medical Group

Ventura, California, United States

Washington Hospital Center

Outcomes

Primary Outcomes

Serious Adverse Device Effect (SADE)-Free Rate at 3 Months

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.

Time frame: 3 months post implant

Implant Success Rate of the Solia S Lead in LBB Area

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.

Time frame: at implant procedure

Secondary Outcomes

Quality of Life (QOL) From Baseline Through 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.

Data from ClinicalTrials.gov

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Washington D.C., District of Columbia, United States

Sarasota Memorial Health Care System

Sarasota, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Cardiology Associates

Tupelo, Mississippi, United States

NYU Langone Health

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

...and 4 more locations

Time frame: 12 months post implant

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

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.

Time frame: 6 months post implant

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

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.

Time frame: 12 months post implant

Pacing Threshold Measurements for Solia S Lead at 3 Months

Pacing threshold measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.

Time frame: 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 LBBA at the 3 month follow-up visit.

Time frame: 3 months post implant

Pacing Impedance for Solia S Lead at 3 Months

Pacing impedance measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.

Time frame: 3 months post implant

Pacing Threshold Measurements for Solia S Lead at 6 Months

Pacing threshold measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.

Time frame: 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 LBBA at the 6 month follow-up visit.

Time frame: 6 months post implant

Pacing Impedance for Solia S Lead at 6 Months

Pacing impedance measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.

Time frame: 6 months post implant

Pacing Threshold Measurements for Solia S Lead at 12 Months

Pacing threshold measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.

Time frame: 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 LBBA at the 12 month follow-up visit.

Time frame: 12 months post implant

Pacing Impedance for Solia S Lead at 12 Months

Pacing impedance measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.

Time frame: 12 months post implant