Cardiac Resynchronization TherapyGUIDENCT06509763
ElectrocardioGraphic Imaging During Left bUndle Branch Implant to valiDate Ecg Criteria
A study testing ECGI system during LBBP implant in people with Cardiac Resynchronization Therapy, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The goal is to validate the resynchronization criteria with a non-invasive technique, during the LBBP implant. Non-invasive real-time ventricular activation maps will be created and analyzed before, during, and after the implantation of the left bundle branch lead, including right septal pacing, mid and deep septal… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiac Resynchronization Therapy
- What is being tested?
- ECGI system during LBBP implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 29 Sep 2022to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left bundle branch pacing indication
- Capability of standing up to place the ECGI vest
Who cannot join
- Less than 18 years-old
- Patients with cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
The goal is to validate the resynchronization criteria with a non-invasive technique, during the LBBP implant. Non-invasive real-time ventricular activation maps will be created and analyzed before, during, and after the implantation of the left bundle branch lead, including right septal pacing, mid and deep septal pacing and pacing when reaching the left bundle branch according to the published standard LBBP criteria. Using these maps, the investigators will quantify activation times and evaluate changes in the ventricular sequence during implantation.
- Conditions
- Cardiac Resynchronization Therapy
- Being tested
- ECGI system during LBBP implant
- Keywords
- Electrocardiographic Imaging, Left Bundle Branch Pacing, Cardiac Resynchronization Therapy, Conduction System Pacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGI system during LBBP implantDevice
ECGI system to create non-invasive ventricular maps during the screwing steps of the LBBP electrode
| Study group | Role | What they receive |
|---|---|---|
| Left Bundle Branch electrode implant | Experimental | Not described Receives: Device: ECGI system during LBBP implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular resynchronization assessed by ECGI
Resynchronization assesed by non-invasive ECGI by the Left Ventricle Activation Time reduction and the septal activation ventricular pattern once reaching the LBBP according to the published ECG criteria.
Measured: During procedure
Secondary outcomes (5)
VEU
Ventricular Electrical Uncoupling computed as the difference between the mean activation time of the left and the right ventricle
Measured: During procedure
LVDI
Left Ventricle Dyssinchrony Index computed as the standard deviation of individual activations recorded from the left ventricle.
Measured: During procedure
Histogram Overlap
Overlapping of the right ventricle and left ventricle activation times histogram distributions as a parameter to assess the dyssinchrony between ventricles.
Measured: During procedure
LVAT
Left Ventricular Activation Time computed as the difference between the earliest and the latest actvation of the left ventricle
Measured: During procedure
Isochronal Crowding
Number of Isochrones presented in the left ventricular activation map to assess the homogeneity of the activation
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start29 Sep 2022
- Primary completion15 Oct 2024
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiac Resynchronization TherapyStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
- Investigators
- Jose Maria Tolosana, MD, PhD, Principal investigator, Hospital Clinic of BarcelonaMargarida Pujol, MD, PhD, Study director, Hospital Clinic of BarcelonaLluis Mont Girbau, MD,PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509763
- Sponsor's protocol ID
- GUIDE
- Acronym
- GUIDE
- Status last verified
- Mar 2026
- First submitted
- 15 Jul 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang W, Huang J, Qi Y, Wang F, Guo L, Shi X, Wu W, Zhou X, Li R. Cardiac resynchronization therapy by left bundle branch area pacing in patients with heart failure and left bundle branch block. Heart Rhythm. 2019 Dec;16(12):1783-1790. doi: 10.1016/j.hrthm.2019.09.006. Epub 2019 Sep 9.
PubMed 31513945Cai B, Huang X, Li L, Guo J, Chen S, Meng F, Wang H, Lin B, Su M. Evaluation of cardiac synchrony in left bundle branch pacing: Insights from echocardiographic research. J Cardiovasc Electrophysiol. 2020 Feb;31(2):560-569. doi: 10.1111/jce.14342. Epub 2020 Jan 20.
PubMed 31919928Zhang S, Zhou X, Gold MR. Left Bundle Branch Pacing: JACC Review Topic of the Week. J Am Coll Cardiol. 2019 Dec 17;74(24):3039-3049. doi: 10.1016/j.jacc.2019.10.039. Epub 2019 Dec 9.
PubMed 31865972Wu S, Chen X, Wang S, Xu L, Xiao F, Huang Z, Zheng R, Jiang L, Vijayaraman P, Sharma PS, Su L, Huang W. Evaluation of the Criteria to Distinguish Left Bundle Branch Pacing From Left Ventricular Septal Pacing. JACC Clin Electrophysiol. 2021 Sep;7(9):1166-1177. doi: 10.1016/j.jacep.2021.02.018. Epub 2021 Apr 28.
PubMed 33933414Huang W, Chen X, Su L, Wu S, Xia X, Vijayaraman P. A beginner's guide to permanent left bundle branch pacing. Heart Rhythm. 2019 Dec;16(12):1791-1796. doi: 10.1016/j.hrthm.2019.06.016. Epub 2019 Jun 22. No abstract available.
PubMed 31233818Ploux S, Lumens J, Whinnett Z, Montaudon M, Strom M, Ramanathan C, Derval N, Zemmoura A, Denis A, De Guillebon M, Shah A, Hocini M, Jais P, Ritter P, Haissaguerre M, Wilkoff BL, Bordachar P. Noninvasive electrocardiographic mapping to improve patient selection for cardiac resynchronization therapy: beyond QRS duration and left bundle branch block morphology. J Am Coll Cardiol. 2013 Jun 18;61(24):2435-2443. doi: 10.1016/j.jacc.2013.01.093. Epub 2013 Apr 16.
PubMed 23602768Elliott MK, Blauer J, Mehta VS, Sidhu BS, Gould J, Jackson T, Sieniewicz B, Niederer S, Ghosh S, Rinaldi CA. Comparison of electrical dyssynchrony parameters between electrocardiographic imaging and a simulated ECG belt. J Electrocardiol. 2021 Sep-Oct;68:117-123. doi: 10.1016/j.jelectrocard.2021.08.003. Epub 2021 Aug 8.
PubMed 34416669
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ElectrocardioGraphic Imaging During Left bUndle Branch Implant to valiDate Ecg Criteria
- ClinicalTrials.gov ID
- NCT06509763
- Acronym / sponsor ID
- GUIDE / GUIDE
- Conditions
- Cardiac Resynchronization Therapy
- Keywords
- Electrocardiographic Imaging, Left Bundle Branch Pacing, Cardiac Resynchronization Therapy, Conduction System Pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to validate the resynchronization criteria with a non-invasive technique, during the LBBP implant. Non-invasive real-time ventricular activation maps will be created and analyzed before, during, and after the implantation of the left bundle branch lead, including right septal pacing, mid and deep septal pacing and pacing when reaching the left bundle branch according to the published standard LBBP criteria. Using these maps, the investigators will quantify activation times and evaluate changes in the ventricular sequence during implantation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left Bundle Branch electrode implant | Experimental | Device: ECGI system during LBBP implant |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Left bundle branch pacing indication
- Capability of standing up to place the ECGI vest
Key exclusion criteria (2 listed)
- Less than 18 years-old
- Patients with cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECGI system during LBBP implantECGI system to create non-invasive ventricular maps during the screwing steps of the LBBP electrode | Device | Left Bundle Branch electrode implant |
Primary outcome
Left ventricular resynchronization assessed by ECGI
Time frame: During procedure
Resynchronization assesed by non-invasive ECGI by the Left Ventricle Activation Time reduction and the septal activation ventricular pattern once reaching the LBBP according to the published ECG criteria.
5 secondary outcomes
VEU
Time frame: During procedure
LVDI
Time frame: During procedure
Histogram Overlap
Time frame: During procedure
LVAT
Time frame: During procedure
Isochronal Crowding
Time frame: During procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 31513945Zhang W, Huang J, Qi Y, Wang F, Guo L, Shi X, Wu W, Zhou X, Li R. Cardiac resynchronization therapy by left bundle branch area pacing in patients with heart failure and left bundle branch block. Heart Rhythm. 2019 Dec;16(12):1783-1790. doi: 10.1016/j.hrthm.2019.09.006. Epub 2019 Sep 9.
- Background: PubMed 31919928Cai B, Huang X, Li L, Guo J, Chen S, Meng F, Wang H, Lin B, Su M. Evaluation of cardiac synchrony in left bundle branch pacing: Insights from echocardiographic research. J Cardiovasc Electrophysiol. 2020 Feb;31(2):560-569. doi: 10.1111/jce.14342. Epub 2020 Jan 20.
- Background: PubMed 31865972Zhang S, Zhou X, Gold MR. Left Bundle Branch Pacing: JACC Review Topic of the Week. J Am Coll Cardiol. 2019 Dec 17;74(24):3039-3049. doi: 10.1016/j.jacc.2019.10.039. Epub 2019 Dec 9.
- Background: PubMed 33933414Wu S, Chen X, Wang S, Xu L, Xiao F, Huang Z, Zheng R, Jiang L, Vijayaraman P, Sharma PS, Su L, Huang W. Evaluation of the Criteria to Distinguish Left Bundle Branch Pacing From Left Ventricular Septal Pacing. JACC Clin Electrophysiol. 2021 Sep;7(9):1166-1177. doi: 10.1016/j.jacep.2021.02.018. Epub 2021 Apr 28.
- Background: PubMed 31233818Huang W, Chen X, Su L, Wu S, Xia X, Vijayaraman P. A beginner's guide to permanent left bundle branch pacing. Heart Rhythm. 2019 Dec;16(12):1791-1796. doi: 10.1016/j.hrthm.2019.06.016. Epub 2019 Jun 22. No abstract available.
- Background: PubMed 23602768Ploux S, Lumens J, Whinnett Z, Montaudon M, Strom M, Ramanathan C, Derval N, Zemmoura A, Denis A, De Guillebon M, Shah A, Hocini M, Jais P, Ritter P, Haissaguerre M, Wilkoff BL, Bordachar P. Noninvasive electrocardiographic mapping to improve patient selection for cardiac resynchronization therapy: beyond QRS duration and left bundle branch block morphology. J Am Coll Cardiol. 2013 Jun 18;61(24):2435-2443. doi: 10.1016/j.jacc.2013.01.093. Epub 2013 Apr 16.
- Background: PubMed 34416669Elliott MK, Blauer J, Mehta VS, Sidhu BS, Gould J, Jackson T, Sieniewicz B, Niederer S, Ghosh S, Rinaldi CA. Comparison of electrical dyssynchrony parameters between electrocardiographic imaging and a simulated ECG belt. J Electrocardiol. 2021 Sep-Oct;68:117-123. doi: 10.1016/j.jelectrocard.2021.08.003. Epub 2021 Aug 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Maria Tolosana, MD, PhD principal investigator
Hospital Clinic of Barcelona
Margarida Pujol, MD, PhD study director
Hospital Clinic of Barcelona
Lluis Mont Girbau, MD,PhD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECGI system during LBBP implant in people with Cardiac Resynchronization Therapy, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular resynchronization assessed by ECGI (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06509763, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.