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.

Study Overview

• Status: Completed
• Conditions: Cardiac Pacing; Pacing Therapy

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.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310020
      • Sir Run Run Shaw Hospital
    • Hangzhou, Zhejiang, China, 310011
      • Zhejiang Greentown Cardiovascular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who received LBBAP for at least 3 months and come back to hospital for regular follow-up will be considered to be recruited voluntarily.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Study Director: Xiaohong Zhou, Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2020
• Primary Completion (Actual): September 6, 2022
• Study Completion (Actual): December 8, 2022

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Bradycardia
• Other Study ID Numbers: aLBBAP study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No