Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Cardiac Rhythm and Heart Failure

About this trial

The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD/CRT-D patients. The main question it aims to answer is:

• Does the LBBP lead can provide accurate, stable, and valid EGM for ICD/CRT-D sensing and detection of ventricular tachyarrhythmia events? In each patient intracardiac EGMs of LBBP lead will be collected by ambulatory Holter monitor at the time of peri-implantation and up to 6-month follow-up. EGM collection will be collected at resting and walking conditions and overdrive pacing.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged >=18 yrs.

Patients indicated for ICD or CRT-D (primary or secondary prevention)

Patients who recently (<=30 days) received ICD/CRT-D implantation with LBBP

Patients' EGM can be digitally recorded

Disqualifiers

Patients received CIED upgrade or replacement with old pacing leads

Patients are pregnant

Patients participate in another study that will confound this study

Trial population

The study selected two study site in China. One is a Tertiary A hospital in Zhejiang Province, and another is a hospital in Shanghai. Both of the two sites locate in south east of China. This study will enroll around 50 subjects who meet the inclusion and exclusion criteria from the ICD or CRT-D patients who have received LBBAP in the two hospitals.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: ICD or CRT-D patients who have received LBBP implantation

Trial outcomes

Primary outcomes

1

R-wave amplitude of LBB EGM

Amplitude in millivolt

Time frame
At the enrollment, 3 months after enrollment and 6 months after enrollment

Secondary outcomes

1

EGM morphology-LVAT

LVAT in millisecond, calculated based on electrogram recorded by LBB lead

Time frame
At the enrollment, 3 months after enrollment and 6 months after enrollment

Other outcomes

1

echocardiography results-LVEF

LVEF in percentage

Time frame
At the enrollment and 6 months after enrollment
2

echocardiography results-SV

SV in millilitre

Time frame
At the enrollment and 6 months after enrollment
3

echocardiography results-LVEDV

LVEDV in millilitre

Time frame
At the enrollment and 6 months after enrollment
4

echocardiography results-LVESV

LVESV in millilitre

Time frame
At the enrollment and 6 months after enrollment

Sponsors and contacts

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