ClinicalTrials.gg
Active, not recruitingNCT06745778Updated Oct 15, 2026

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

An observational study in Ventricular Tachycardia (VT) and Ventricular Fibrillation, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Active, not recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Medtronic Cardiac Rhythm and Heart Failure (part of Medtronic) · Observational

Updated Oct 15, 2026Now Active, not recruitingPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Ventricular Tachycardia (VT)
  • Ventricular Fibrillation
03

In context

Tachycardia, Ventricular

451 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.

This study's enrollment of 50 is below the median of 167 across 147 observational studies indexed under Tachycardia, Ventricular.

Browse Tachycardia, Ventricular studies →

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 240 studies on the registry; 4 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 18 (95%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • Patients are willing to participate in the study and provide signed

Exclusion criteria

Exclusion Criteria:

  • Patients received CIED upgrade or replacement with old pacing leads
  • Patients are pregnant
  • Patients participate in another study that will confound this study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • ICD or CRT-D patients who have received LBBP implantation

    Patients' EGMs can be recorded by Holter DR220

06

What researchers measure

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

  5. echocardiography results-LVEDD

    LVEDD in millimetre

    Time frame: At the enrollment and 6 months after enrollment

  6. echocardiography results-LVESD

    LVESD in millimetre

    Time frame: At the enrollment and 6 months after enrollment

07

Study locations

2 sites
08

References and documents

Publications

  • Ponnusamy SS, Ramalingam V, Ganesan V, Syed T, Kumar M, Mariappan S, Murugan S, Basil W, Vijayaraman P. Left bundle branch pacing-optimized implantable cardioverter-defibrillator (LOT-ICD) for cardiac resynchronization therapy: A pilot study. Heart Rhythm O2. 2022 Dec 16;3(6Part B):723-727. doi: 10.1016/j.hroo.2022.08.004. eCollection 2022 Dec. PubMed 36589004 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2025 to primary completion in Aug 2026, 17 months.

Of 69 observational studies under Tachycardia, Ventricular, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 108. This study's 17 months is below that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 15, 2026: primary completion Jul 2026 → Aug 2026 and completion Jul 2026 → Oct 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2024
First posted
Dec 20, 2024
StartActual
Feb 26, 2025
Primary completionActual
Aug 18, 2026was Jul 2026
CompletionEst.
Oct 31, 2026was Jul 2026
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 15, 2026
Primary completion
Jul 31, 2026→Aug 18, 2026 (actual)
Oct 15, 2026
Study completion
Jul 31, 2026→Oct 31, 2026
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Recruiting→Active, not recruiting
    Primary completion Jul 31, 2026→Aug 18, 2026 (now actual)
    Study completion Jul 31, 2026→Oct 31, 2026
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06745778
Responsible party
Sponsor
First posted
Dec 20, 2024
Start date
Feb 26, 2025
Primary completion
Aug 18, 2026
Completion
Oct 31, 2026 (estimated)
Last update
Oct 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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