Investigating cardiac electrical characteristics in heart failure patients with LBB pacing
Intracardiac Electrical Characteristics of LBBAP
This study is testing how different pacing methods affect heart electrical signals in patients with heart failure who have had left bundle branch area pacing to see if it can improve heart treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic Cardiac Rhythm and Heart Failure Industry-sponsored |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT06540521 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the cardiac electrical characteristics associated with different pacing outputs and body positions in patients undergoing left bundle branch area pacing (LBBAP). It focuses on understanding the differences between LBBAP and left ventricular septal pacing (LVSP) by analyzing electrogram (EGM) characteristics and their correlation with ECG morphology. The findings may contribute to the development of a novel algorithm for determining LBB capture, enhancing the precision of cardiac pacing techniques. The study involves patients who have received LBBAP therapy for at least one month and utilizes real-time intracardiac electrograms from implanted devices.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have received LBBAP therapy for 1 to 4 months and have an appropriate pacemaker device.
Not a fit: Patients who are pregnant or have medical conditions limiting their participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiac pacing techniques, enhancing patient outcomes in heart failure management.
How similar studies have performed: While large randomized trials are lacking, small observational studies have shown promising results for similar pacing approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged \>=18 years * Patients who are willing to provide Informed Consent * Patients who have received LBBAP therapy \>= 1 month for 1 to 4 months (including 1 and 4 month) * Patients implanted with a single/dual-chamber pacemaker or a CRT-P with LBBAP lead connected to RV port * Implanted device can provide at least 3-channel real-time intracardiac electrogram Exclusion Criteria: * Patients who are pregnant or have a plan for pregnancy during the study * Patients who have medical conditions that would limit study participation * Patients who were already enrolled in clinical trial(s) which would impact study participation
Where this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Zhejiang Greentown Cardiovascular Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Simon Cao, PhD
- 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.