Implanting a new pacing lead for heart rhythm issues
BIOTRONIK Conduction System Pacing With the Solia Lead
This study is testing a new heart pacing lead to see if it is safe and effective for people with heart rhythm problems like bradycardia and atrioventricular block.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biotronik, Inc. Industry-sponsored |
| Locations | 10 sites (Phoenix, Arizona and 9 other locations) |
| Trial ID | NCT06540079 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area of the heart. It will assess safety by monitoring serious adverse device effects for three months post-implant and efficacy by measuring the success rate of the implant. Patients who are candidates for a BIOTRONIK pacemaker system will be enrolled and monitored for follow-up visits. The study focuses on individuals with conditions such as sinus node dysfunction, bradycardia, and atrioventricular block.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who require a pacemaker and are suitable for left bundle branch area pacing.
Not a fit: Patients who have contraindications for pacemaker implantation or are already implanted with a pacemaker or ICD device may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve heart pacing techniques and outcomes for patients with specific heart rhythm disorders.
How similar studies have performed: Other studies have explored pacing techniques, but this specific approach with the Solia CSP S lead is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 (LBBA) 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 LBBA * 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
Where this trial is running
Phoenix, Arizona and 9 other locations
- Banner - University Medical Center Phoenix — Phoenix, Arizona, United States (Recruiting)
- Cardiology Associates Medical Group — Ventura, California, United States (Recruiting)
- Sarasota Memorial Hospital — Sarasota, Florida, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Cardiology Associates Research, LLC — Tupelo, Mississippi, United States (Recruiting)
- NYU Heart Rhythm Center — New York, New York, United States (Recruiting)
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
- Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (Recruiting)
- Cardiology Consultants of Philadelphia — Paoli, Pennsylvania, United States (Recruiting)
- Geisinger Wyoming Valley Medical Center — Wilkes-Barre, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Justin Michalski
- Email: bio-conduct@biotronik.com
- Phone: 1-800-547-0394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.