Bolt CSP-M Holter Study
Recruiting · NCT06540521 · Observational (researchers observe without assigning treatment) · Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
View the official record on ClinicalTrials.gov →Interventions studied
No intervention
What this trial is about
The purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in LBB area pacing (LBBAP), from which the findings may help to develop and support data validation of a novel algorithm for LBB capture determination for LBBAP.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
2 locations listed.
- Shanghai Chest Hospital - Shanghai, Shanghai Municipality, China
- Zhejiang Greentown Cardiovascular Hospital - Hangzhou, Zhejiang, China