BIOTRONIK Conduction System Pacing With the Solia Lead

Bradycardia Clinical Trial

— BIO-CONDUCT  

Official title:

BIOTRONIK Conduction System Pacing With the Solia Lead

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05251363
• Other study ID #: G210349
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: March 2024
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 186
• Est. completion date: November 1, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrioventricular Block
• Bradycardia
• Bundle-Branch Block
• Cardiomyopathies
• Left Bundle-Branch Block

Intervention

Device:
• Solia S lead
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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