Bolt CSP-M Holter Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Cardiac Rhythm and Heart Failure
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study selected two study site in China. One is a Tertiary A hospital in Shanghai, and another is a cardiovascular specialty hospital in Zhejiang Province. Both the two sites locate in the south east of China. This study will enroll 70 subjects who meet all the inclusion and exclusion criteria from the patients who have received LBBAP therapies from the two hospitals.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Intracardiac electrical characteristics in different pacing outputs.
12-lead ECG and LBBAP EGM characteristics and duration in different pacing outputs.
Time frame
received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollmentSecondary outcomes
1
Intracardiac electrical characteristics under different body position.
12-lead ECG and LBBAP EGM characteristics and duration under different body positions.
Time frame
received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment2
The correlation between LBB capture status and LBBAP EGM characteristics
ECG and EGM characteristics in different LBB capture status
Time frame
received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov