Image Location and Performance of Left Bundle Branch Pacing

Cardiac Pacing Clinical Trial

Official title:

Image Location and Performance of Left Bundle Branch Pacing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119323
• Other study ID #: IMAGE-LBBP study
• Status: Completed
• Start date: September 24, 2019
• Est. completion date: July 14, 2020

Study information

• Verified date: December 2020
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, multi-site, non-randomized, data collection study. The purpose of this study is to investigate the correlation between pacing sites and ECG morphology or pacing parameters during left bundle branch pacing (LBBP) and perform the use condition analysis to assess the long-term performance of pacing lead during LBBP.

Description:

His bundle pacing (HBP) is a physiological pacing, but also has some limitations, including high and unstable pacing threshold in 5-10% patients, low R-wave amplitude causing inappropriate pacing management, damage to the His bundle during implantation. On the other hand, left bundle branch pacing (LBBP), achieved via trans-ventricular septal approach with the pacing lead tip at the left side of the ventricular septum, has recently initiated and been widely practiced in China because of easy implantation, relatively narrow paced QRS duration, low and stable pacing threshold, high R wave amplitude, and the LBBB correction by a low pacing output.

As LBBP is in the early phase of clinical practice in China, in order to better conduct LBBP implantation and understand mechanisms of LBBP therapy, physicians often do imaging assessment of the pacing lead in patients implanted with LBBP based on clinical necessity.

Additionally, there is no report of mid/long-term correlation between lead location and ventricular electrical activity, nor mid/long-term pacing lead performance assessment during LBBP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 14, 2020
• Est. primary completion date: July 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Aged from 18 to 80 years old;

• Patients providing signed Informed Consent;

• Patients indicated for permanent pacing and implanted with LBBP for at least 3 months, with documentation of implantation records;

• Patients who plan to receive cardiac CT examination.

Exclusion Criteria:

• Patients who have a history of allergy to contrast agent or refuse to use contrast agent in CT examination;

• Patients who are pregnant or have a plan for pregnancy during the study;

• Patients who are not willing to provide Informed Consent;

• 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

• Cardiac Pacing
• Pacing Therapy

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing
China	West China Hospital	Chengdu	Sichuan
China	Jiangsu Province Hospital	Nanjing	Jiangsu

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	QRS duration	The primary endpoint is QRS duration and morphology during LBBP	at least 3 months after implant