NCT06745778 Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D
| NCT ID | NCT06745778 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medtronic Cardiac Rhythm and Heart Failure |
| Condition | Ventricular Tachycardia (VT) |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-02-26 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-02-26 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD/CRT-D patients. The main question it aims to answer is: • Does the LBBP lead can provide accurate, stable, and valid EGM for ICD/CRT-D sensing and detection of ventricular tachyarrhythmia events? In each patient intracardiac EGMs of LBBP lead will be collected by ambulatory Holter monitor at the time of peri-implantation and up to 6-month follow-up. EGM collection will be collected at resting and walking conditions and overdrive pacing.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06745778 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventricular Tachycardia (VT). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06745778 currently recruiting?
Yes, NCT06745778 is actively recruiting participants. Contact the research team at simon.cao@medtronic.com for enrollment information.
Where is the NCT06745778 trial being conducted?
This trial is being conducted at Wenzhou, China, Shanghai, China.
Who is sponsoring the NCT06745778 clinical trial?
NCT06745778 is sponsored by Medtronic Cardiac Rhythm and Heart Failure. The trial plans to enroll 50 participants.