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Bolt CSP-M Holter Study

RECRUITINGSponsored by Medtronic Cardiac Rhythm and Heart Failure
Actively Recruiting
SponsorMedtronic Cardiac Rhythm and Heart Failure
Started2024-08-13
Est. completion2026-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06540521

Summary

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

BradycardiaHeart DiseaseHeart Failure

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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