Electrogram and Hemodynamic Characteristics of Adaptive LBBAP in Patients With Heart Failure or Bradycardia

  • STATUS
    Recruiting
  • End date
    Jul 14, 2022
  • participants needed
    50
  • sponsor
    Medtronic Cardiac Rhythm and Heart Failure
Updated on 14 February 2021

Summary

This is a multi-site, non-randomized, data collection study. The purpose of this study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals.

Description

Left bundle branch pacing (LBBP), achieved via trans-septal approach with the pacing tip at the left side of the ventricular septum, has recently initiated and been well practiced in China. LBBP is characterized with relatively ease of implantation (usually <5 minutes fluoroscopic use time), narrow paced QRS duration (similar to physiological pacing), low and stable pacing threshold (usually around 0.5V @0.5ms, good for device longevity and long-term stability without need of back-up pacing lead), high R wave amplitude for pacing management, and LBBB (left bundle branch block) correction by a low pacing output.

LBBAP (left bundle branch area pacing) can generate a relatively narrow QRSd and fast left ventricular activation. As AV interval is an important pacing parameter relevant to cardiac function. This study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals.

Details
Condition Cardiac Pacing, Pacing Therapy
Clinical Study IdentifierNCT04738396
SponsorMedtronic Cardiac Rhythm and Heart Failure
Last Modified on14 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged from 18 to 80 years old
Patients who are willing to provide Informed Consent
Patients who received LBBAP for at least 3 months
Patients' implanted device can provide intracardiac electrograms
Bradycardia patients with AVB or heart failure patients with LBBB

Exclusion Criteria

Patients who are pregnant or have a plan for pregnancy during the study
Patients with persistent AF
Patients who have medical conditions that would limit study participation
Patients who were already enrolled in other clinical trial which would impact his/her participation
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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