RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

BIOTRONIK Conduction System Pacing With the Solia Lead

Quick Facts

Study Start:2024-12-18
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06540079

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and CRT-P systems are allowed.
  2. * Patient has an implant planned to utilize left bundle branch area (LBBA) pacing within 30 days of consent
  3. * Patient is able to understand the nature of the study and provide written informed consent
  4. * Patient is available for follow-up visits on a regular basis for the expected duration of follow-up
  5. * Patient accepts Home Monitoring® concept
  6. * Patient age is greater than or equal to 18 years at time of consent
  1. * Patient meets a standard contraindication for pacemaker system implant
  2. * Patient is currently implanted with a pacemaker or ICD device
  3. * Patient has had a previous unsuccessful attempt to place a lead in the LBBA
  4. * Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
  5. * Patient is expected to receive a heart transplant within 12 months
  6. * Patient life expectancy less than 12 months
  7. * Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
  8. * Patient reports pregnancy at the time of enrollment
  9. * Patient is enrolled in any other investigational cardiac clinical study during the course of the study

Contacts and Locations

Study Contact

Justin Michalski
CONTACT
1-800-547-0394
bio-conduct@biotronik.com

Study Locations (Sites)

Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
United States
Cardiology Associates Medical Group
Ventura, California, 93003
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
University of Chicago
Chicago, Illinois, 60637
United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, 38801
United States
NYU Heart Rhythm Center
New York, New York, 10016
United States
Weill Cornell Medicine
New York, New York, 10021
United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
United States
Cardiology Consultants of Philadelphia
Paoli, Pennsylvania, 19301
United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
United States

Collaborators and Investigators

Sponsor: Biotronik, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-18
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-12-18
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Sinus Node Dysfunction
  • Bradycardia
  • Atrioventricular Block