Investigating heart signals from a specific pacing lead in patients with implantable devices
Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D
This study looks at how well a specific heart lead can track heart signals in people with implantable devices during their daily activities to see if it can accurately detect fast heart rhythms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic Cardiac Rhythm and Heart Failure Industry-sponsored |
| Locations | 2 sites (Wenzhou, Zhejiang and 1 other locations) |
| Trial ID | NCT06745778 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the changes in intracardiac electrograms (EGMs) recorded by the left bundle branch pacing (LBBP) lead in patients who have received implantable cardioverter-defibrillators (ICD) or cardiac resynchronization therapy devices (CRT-D). The study will monitor these signals during daily activities and overdrive pacing, starting from the time of device implantation and continuing for up to six months. By collecting EGM data through ambulatory Holter monitoring, the study seeks to determine the accuracy and stability of the LBBP lead in detecting ventricular tachyarrhythmia events.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have recently received an ICD or CRT-D with LBBP for either primary or secondary prevention.
Not a fit: Patients who have undergone device upgrades or replacements with older pacing leads, or those who are pregnant, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the reliability of arrhythmia detection in patients with ICDs and CRT-Ds, potentially improving patient outcomes.
How similar studies have performed: While this approach is observational and may build on existing knowledge, the specific use of LBBP leads for EGM monitoring in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged \>=18 yrs. * Patients indicated for ICD or CRT-D (primary or secondary prevention) * Patients who recently (\<=30 days) received ICD/CRT-D implantation with LBBP * Patients' EGM can be digitally recorded * Patients are willing to participate in the study and provide signed informed consent Exclusion Criteria: * Patients received CIED upgrade or replacement with old pacing leads * Patients are pregnant * Patients participate in another study that will confound this study
Where this trial is running
Wenzhou, Zhejiang and 1 other locations
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
- Shanghai Tongren Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Simon Cao, Ph.D
- Email: simon.cao@medtronic.com
- Phone: 862133230325
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.