Left Bundle-Branch PacingSTYLE-LBBPNCT06049992
STylet-driven vs. LumenlEss Lead in Left-Bundle-Branch Pacing
A study testing Pacemaker implantation with conduction system pacing using Lumenless leads and Pacemaker implantation with conduction system pacing using Stylet-driven leads in people with Left Bundle-Branch Pacing, run by Puerta de Hierro University Hospital at 2 sites in Spain.
Trial summary
The STYLE-LBBP study aims to compare the efficacy and safety of left-bundle branch pacing between the two types of available pacing leads: lumenless vs stylet-driven. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Bundle-Branch Pacing
- What is being tested?
- Pacemaker implantation with conduction system pacing using Lumenless leads and Pacemaker implantation with conduction system pacing using Stylet-driven leads
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSpain
- Study dates
- 21 Sep 2023to 22 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patients referred for conduction system pacing
Who cannot join
- Patients with a prosthetic (metal or biologic) tricuspid valve.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Not yet recruiting
Fundación Jiménez Díaz University Hospital
Madrid, 28040
Jose Manuel Rubio, MD
- Recruiting
Puerta de Hierro University Hospital
Majadahonda, Madrid, 28222
Alvaro Lorente-Ros, MD
About this study
Official title: Stylet-driven vs. Lumenless Lead in Left-Bundle-Branch Pacing Randomized Trial
The STYLE-LBBP study aims to compare the efficacy and safety of left-bundle branch pacing between the two types of available pacing leads: lumenless vs stylet-driven.
Read the detailed description
STYLE-LBBP is a randomized, non-blinded, multicenter clinical trial that compares the efficacy and safety of two types of available pacing leads in conduction system pacing (CSP). Patients referred to CSP who meet the inclusion and exclusion criteria will be enrolled and randomized into two groups: i)Left bundle branch pacing (LBBP) using leads without internal light (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA) or ii) LBBP with stylet-driven leads (Tendril STS 2088TC, Abbott, Inc., USA; Solia S60, Biotronik, SE \& Co., KG, Germany; Ingevity +, Boston Scientific, Marlborough, MA, USA).
Efficacy in terms of achieving LBBP (selective and non-selective left bundle capture criteria) will be measured at implantation and after 24 hours. Complications of the procedure will also be recorded.
- Conditions
- Left Bundle-Branch Pacing
- Being tested
- Pacemaker implantation with conduction system pacing using Lumenless leads, Pacemaker implantation with conduction system pacing using Stylet-driven leads
- Keywords
- Left bundle-branch pacing, Conduction system pacing, Leadless, Stylet-driven pacing leads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantation with conduction system pacing using Lumenless leadsDevice
Pacemaker implantation for conduction system pacing will be done using leads without internal lumen (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA).
Pacemaker implantation with conduction system pacing using Stylet-driven leadsDevice
Pacemaker implantation for conduction system pacing will be done using leads with internal lumen and retractable helix (Tendril STS 2088TC, Abbott, Inc., USA; Solia S60, Biotronik, SE \& Co., KG, Germany; Ingevity +, Boston Scientific, Marlborough, MA, USA)
| Study group | Role | What they receive |
|---|---|---|
| Lumenless lead | Active comparator | Left bundle branch stimulation using leads without internal lumen (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA). Receives: Device: Pacemaker implantation with conduction system pacing using Lumenless leads |
| Stylet-driven lead | Active comparator | Left bundle branch pacing using leads with internal lumen and retractable helix (Tendril STS 2088TC, Abbott, Inc., USA; Solia S60, Biotronik, SE \& Co., KG, Germany; Ingevity +, Boston Scientific, Marlborough, MA, USA). Receives: Device: Pacemaker implantation with conduction system pacing using Stylet-driven leads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in which left-bundle branch pacing is achieved at implantation
Defined as a paced (pseudo) right bundle branch block QRS morphology with terminal r/R' in lead V1 and any of the following: i) recording of a LBB potential during intrinsic rhythm (only in patients with normal ventricular activation), ii) transition from non-selective to selective LBBP or non-selective LBBP to LV myocardial capture during decreasing pacing output, iii) abrupt shortening of stimulus to R wave peak time in V6 ECG lead (V6RWPT) ≥10 ms during implantation, iv) V6RWPT < 75ms or < 80ms in patients with preexisting left bundle branch block or v) an interpeak interval (V1RWPT - V6RWPT) ≥ 33ms.
Measured: Baseline (During implantation)
Proportion of patients with left-bundle branch pacing criteria at 24 hours
Defined as a paced (pseudo) right bundle branch block QRS morphology with terminal r/R' in lead V1 and any of the following: i) recording of a LBB potential during intrinsic rhythm (only in patients with normal ventricular activation), ii) transition from non-selective to selective LBBP or non-selective LBBP to LV myocardial capture during decreasing pacing output, iii) abrupt shortening of stimulus to R wave peak time in V6 ECG lead (V6RWPT) ≥10 ms during implantation, iv) V6RWPT < 75ms or < 80ms in patients with preexisting left bundle branch block or v) an interpeak interval (V1RWPT - V6RWPT) ≥ 33ms.
Measured: At 24 hours (before discharge)
Secondary outcomes (1)
Procedural complications
Number of patients with major and minor complications related to the procedure (death, perforation, cardiac tamponade, lead dislodgment, loss of capture or need for reintervention)
Measured: At 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start21 Sep 2023
- Primary completion21 Sep 2025 (estimated)
- Study completion22 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Left Bundle-Branch PacingStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Cardiology
- Responsible party
- Principal investigator, Alvaro Lorente-Ros, Puerta de Hierro University Hospital
- Investigators
- Alvaro Lorente-Ros, MD, Principal investigator, Puerta de Hierro University HospitalVictor Castro-Urda, MD, Study director, Puerta de Hierro University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049992
- Sponsor's protocol ID
- STYLE-LBBP 2023
- Acronym
- STYLE-LBBP
- Status last verified
- Dec 2023
- First submitted
- 11 Sep 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.
PubMed 34455430Hou X, Qian Z, Wang Y, Qiu Y, Chen X, Jiang H, Jiang Z, Wu H, Zhao Z, Zhou W, Zou J. Feasibility and cardiac synchrony of permanent left bundle branch pacing through the interventricular septum. Europace. 2019 Nov 1;21(11):1694-1702. doi: 10.1093/europace/euz188.
PubMed 31322651Vijayaraman P, Ponnusamy S, Cano O, Sharma PS, Naperkowski A, Subsposh FA, Moskal P, Bednarek A, Dal Forno AR, Young W, Nanda S, Beer D, Herweg B, Jastrzebski M. Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: Results From the International LBBAP Collaborative Study Group. JACC Clin Electrophysiol. 2021 Feb;7(2):135-147. doi: 10.1016/j.jacep.2020.08.015. Epub 2020 Oct 28.
PubMed 33602393Zhang 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 31865972Tan JL, Lee JZ, Terrigno V, Saracco B, Saxena S, Krathen J, Hunter K, Cha YM, Russo AM. Outcomes of Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: An Updated Systematic Review and Meta-analysis. CJC Open. 2021 Jun 16;3(10):1282-1293. doi: 10.1016/j.cjco.2021.05.019. eCollection 2021 Oct.
PubMed 34888508De Pooter J, Wauters A, Van Heuverswyn F, Le Polain de Waroux JB. A Guide to Left Bundle Branch Area Pacing Using Stylet-Driven Pacing Leads. Front Cardiovasc Med. 2022 Feb 21;9:844152. doi: 10.3389/fcvm.2022.844152. eCollection 2022.
PubMed 35265691Braunstein ED, Kagan RD, Olshan DS, Gabriels JK, Thomas G, Ip JE, Markowitz SM, Lerman BB, Liu CF, Cheung JW. Initial experience with stylet-driven versus lumenless lead delivery systems for left bundle branch area pacing. J Cardiovasc Electrophysiol. 2023 Mar;34(3):710-717. doi: 10.1111/jce.15789. Epub 2022 Dec 30.
PubMed 36571159Shimeno K, Tamura S, Hayashi Y, Abe Y, Naruko T, Fukuda D. Achievement rate and learning curve of left bundle branch capture in left bundle branch area pacing procedure performed to demonstrate output-dependent QRS transition. J Cardiovasc Electrophysiol. 2022 Oct;33(10):2183-2191. doi: 10.1111/jce.15627. Epub 2022 Jul 23.
PubMed 35842801Huang 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 31233818
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stylet-driven vs. Lumenless Lead in Left-Bundle-Branch Pacing Randomized Trial
- ClinicalTrials.gov ID
- NCT06049992
- Acronym / sponsor ID
- STYLE-LBBP / STYLE-LBBP 2023
- Conditions
- Left Bundle-Branch Pacing
- Keywords
- Left bundle-branch pacing, Conduction system pacing, Leadless, Stylet-driven pacing leads
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Collaborators
- Spanish Society of Cardiology
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 21 Sep 2025 (estimated)
- Study completion
- 22 Sep 2025 (estimated)
- First posted
- 22 Sep 2023 (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 STYLE-LBBP study aims to compare the efficacy and safety of left-bundle branch pacing between the two types of available pacing leads: lumenless vs stylet-driven.
Detailed description
STYLE-LBBP is a randomized, non-blinded, multicenter clinical trial that compares the efficacy and safety of two types of available pacing leads in conduction system pacing (CSP). Patients referred to CSP who meet the inclusion and exclusion criteria will be enrolled and randomized into two groups: i)Left bundle branch pacing (LBBP) using leads without internal light (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA) or ii) LBBP with stylet-driven leads (Tendril STS 2088TC, Abbott, Inc., USA; Solia S60, Biotronik, SE \& Co., KG, Germany; Ingevity +, Boston Scientific, Marlborough, MA, USA).
Efficacy in terms of achieving LBBP (selective and non-selective left bundle capture criteria) will be measured at implantation and after 24 hours. Complications of the procedure will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumenless lead | Active comparator | Device: Pacemaker implantation with conduction system pacing using Lumenless leadsLeft bundle branch stimulation using leads without internal lumen (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA). |
| Stylet-driven lead | Active comparator | Device: Pacemaker implantation with conduction system pacing using Stylet-driven leadsLeft bundle branch pacing using leads with internal lumen and retractable helix (Tendril STS 2088TC, Abbott, Inc., USA; Solia S60, Biotronik, SE \& Co., KG, Germany; Ingevity +, Boston Scientific, Marlborough, MA, USA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Patients referred for conduction system pacing
Key exclusion criteria (1 listed)
- Patients with a prosthetic (metal or biologic) tricuspid valve.
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 |
|---|---|---|
| Pacemaker implantation with conduction system pacing using Lumenless leadsPacemaker implantation for conduction system pacing will be done using leads without internal lumen (Lumenless; Medtronic Selectsecure 3830, Minneapolis, USA). | Device | Lumenless lead |
| Pacemaker implantation with conduction system pacing using Stylet-driven leadsPacemaker implantation for conduction system pacing will be done using leads with internal lumen and retractable helix (Tendril STS 2088TC, Abbott, Inc., USA; Solia S60, Biotronik, SE \& Co., KG, Germany; Ingevity +, Boston Scientific, Marlborough, MA, USA) | Device | Stylet-driven lead |
Primary outcome
Proportion of patients in which left-bundle branch pacing is achieved at implantation
Time frame: Baseline (During implantation)
Defined as a paced (pseudo) right bundle branch block QRS morphology with terminal r/R' in lead V1 and any of the following: i) recording of a LBB potential during intrinsic rhythm (only in patients with normal ventricular activation), ii) transition from non-selective to selective LBBP or non-selective LBBP to LV myocardial capture during decreasing pacing output, iii) abrupt shortening of stimulus to R wave peak time in V6 ECG lead (V6RWPT) ≥10 ms during implantation, iv) V6RWPT < 75ms or < 80ms in patients with preexisting left bundle branch block or v) an interpeak interval (V1RWPT - V6RWPT) ≥ 33ms.
Proportion of patients with left-bundle branch pacing criteria at 24 hours
Time frame: At 24 hours (before discharge)
Defined as a paced (pseudo) right bundle branch block QRS morphology with terminal r/R' in lead V1 and any of the following: i) recording of a LBB potential during intrinsic rhythm (only in patients with normal ventricular activation), ii) transition from non-selective to selective LBBP or non-selective LBBP to LV myocardial capture during decreasing pacing output, iii) abrupt shortening of stimulus to R wave peak time in V6 ECG lead (V6RWPT) ≥10 ms during implantation, iv) V6RWPT < 75ms or < 80ms in patients with preexisting left bundle branch block or v) an interpeak interval (V1RWPT - V6RWPT) ≥ 33ms.
1 secondary outcome
Procedural complications
Time frame: At 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Background: PubMed 34455430Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.
- Background: PubMed 31322651Hou X, Qian Z, Wang Y, Qiu Y, Chen X, Jiang H, Jiang Z, Wu H, Zhao Z, Zhou W, Zou J. Feasibility and cardiac synchrony of permanent left bundle branch pacing through the interventricular septum. Europace. 2019 Nov 1;21(11):1694-1702. doi: 10.1093/europace/euz188.
- Background: PubMed 33602393Vijayaraman P, Ponnusamy S, Cano O, Sharma PS, Naperkowski A, Subsposh FA, Moskal P, Bednarek A, Dal Forno AR, Young W, Nanda S, Beer D, Herweg B, Jastrzebski M. Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: Results From the International LBBAP Collaborative Study Group. JACC Clin Electrophysiol. 2021 Feb;7(2):135-147. doi: 10.1016/j.jacep.2020.08.015. Epub 2020 Oct 28.
- 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 34888508Tan JL, Lee JZ, Terrigno V, Saracco B, Saxena S, Krathen J, Hunter K, Cha YM, Russo AM. Outcomes of Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: An Updated Systematic Review and Meta-analysis. CJC Open. 2021 Jun 16;3(10):1282-1293. doi: 10.1016/j.cjco.2021.05.019. eCollection 2021 Oct.
- Background: PubMed 35265691De Pooter J, Wauters A, Van Heuverswyn F, Le Polain de Waroux JB. A Guide to Left Bundle Branch Area Pacing Using Stylet-Driven Pacing Leads. Front Cardiovasc Med. 2022 Feb 21;9:844152. doi: 10.3389/fcvm.2022.844152. eCollection 2022.
- Background: PubMed 36571159Braunstein ED, Kagan RD, Olshan DS, Gabriels JK, Thomas G, Ip JE, Markowitz SM, Lerman BB, Liu CF, Cheung JW. Initial experience with stylet-driven versus lumenless lead delivery systems for left bundle branch area pacing. J Cardiovasc Electrophysiol. 2023 Mar;34(3):710-717. doi: 10.1111/jce.15789. Epub 2022 Dec 30.
- Background: PubMed 35842801Shimeno K, Tamura S, Hayashi Y, Abe Y, Naruko T, Fukuda D. Achievement rate and learning curve of left bundle branch capture in left bundle branch area pacing procedure performed to demonstrate output-dependent QRS transition. J Cardiovasc Electrophysiol. 2022 Oct;33(10):2183-2191. doi: 10.1111/jce.15627. Epub 2022 Jul 23.
- 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.
- 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.
Alvaro Lorente-Ros, MD principal investigator
Puerta de Hierro University Hospital
Victor Castro-Urda, MD study director
Puerta de Hierro University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker implantation with conduction system pacing using Lumenless leads and Pacemaker implantation with conduction system pacing using Stylet-driven leads in people with Left Bundle-Branch Pacing, run by Puerta de Hierro University Hospital at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alvaro Lorente-Ros, MD (911916000, alvaro.lorente@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in which left-bundle branch pacing is achieved at implantation (time frame: Baseline (During implantation)). The study lists 2 primary outcomes in all. 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 NCT06049992, which also lists 9 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 29 Dec 2023; AzTrials last refreshed its copy on 28 Oct 2026.