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

Cardiac Pacing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738396
• Other study ID #: aLBBAP study
• Status: Completed
• Start date: December 29, 2020
• Est. completion date: December 8, 2022

Study information

• Verified date: February 2023
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 8, 2022
• Est. primary completion date: September 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Cardiac Pacing
• Heart Failure
• Pacing Therapy

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	Zhejiang Greentown Cardiovascular Hospital	Hangzhou	Zhejiang
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

China, 

Outcome

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