Bolt CSP-M Holter Study

Launched by MEDTRONIC CARDIAC RHYTHM AND HEART FAILURE · Aug 1, 2024

Keywords

ClinConnect Summary

The Bolt CSP-M Holter Study is looking at how the heart's electrical signals change based on different settings and body positions in patients with heart failure or slow heart rates (bradycardia) who are receiving a specific type of pacing therapy called Left Bundle Branch Area Pacing (LBBAP). This research aims to gather information that could help create a new tool to determine how well this pacing is working.

To participate in the study, you need to be at least 18 years old and have been using LBBAP therapy for at least one month. You should also have a specific type of pacemaker that allows for detailed heart monitoring. Unfortunately, if you are pregnant or have certain health issues that could affect your ability to take part, you would not be eligible. If you join the study, you can expect to have your heart activity closely monitored while researchers gather data to improve patient care in the future.

Gender

ALL

Eligibility 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