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Completed

NCT Number: NCT04738396

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

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.

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Key information

Conditions

Cardiac Pacing Pacing Therapy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. ECG QRS duration

    Time frame: At least 3 months post implant

    The primary endpoint is QRS duration during LBBP

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2021
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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