Clinical trial NCT05251363: BIOTRONIK Conduction System Pacing With the Solia Lead
Official title: BIOTRONIK Conduction System Pacing With the Solia Lead
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Atrioventricular Block
Left Bundle-Branch Block
Cardiomyopathies
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-22
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serious Adverse Device Effect (SADE)-Free Rate at 3 Months
timeFrame: 3 months post implant
measure: Implant Success Rate of the Solia S Lead in LBB Area
timeFrame: at implant procedure
Secondary outcomes:
measure: Quality of Life (QOL) From Baseline Through 12 Months Post-Implant
timeFrame: 12 months post implant
measure: Serious Adverse Device Effect (SADE)-Free Rate at 6 Months
timeFrame: 6 months post implant
measure: Serious Adverse Device Effect (SADE)-Free Rate at 12 Months
timeFrame: 12 months post implant
measure: Pacing Threshold Measurements for Solia S Lead at 3 Months
timeFrame: 3 months post implant
measure: Sensing Measurements for Solia S Lead at 3 Months
timeFrame: 3 months post implant
measure: Pacing Impedance for Solia S Lead at 3 Months
timeFrame: 3 months post implant
measure: Pacing Threshold Measurements for Solia S Lead at 6 Months
timeFrame: 6 months post implant
measure: Sensing Measurements for Solia S Lead at 6 Months
timeFrame: 6 months post implant
measure: Pacing Impedance for Solia S Lead at 6 Months
timeFrame: 6 months post implant
measure: Pacing Threshold Measurements for Solia S Lead at 12 Months
timeFrame: 12 months post implant
measure: Sensing Measurements for Solia S Lead at 12 Months
timeFrame: 12 months post implant
measure: Pacing Impedance for Solia S Lead at 12 Months
timeFrame: 12 months post implant
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner - University Medical Center Phoenix
state: Arizona
city: Ventura
country: United States
facility: Cardiology Associates Medical Group
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Tupelo
country: United States
facility: Cardiology Associates
state: Mississippi
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
Study officials:
References: