Electrogram and Hemodynamic Characteristics of Adaptive LBBAP in Patients With Heart Failure or Bradycardia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 4
- Primary Endpoint
- ECG QRS duration
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
ECG QRS duration
Time Frame: At least 3 months post implant
The primary endpoint is QRS duration during LBBP
Secondary Outcomes
No secondary outcomes reported