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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04738396

Enrollment

Registered

2021-02-04

Start date

2020-12-29

Completion date

2022-12-08

Last updated

2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Pacing, Pacing Therapy

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
ECG QRS duration	At least 3 months post implant	The primary endpoint is QRS duration during LBBP

Countries

China

Outcome results