Pacemaker-Induced CardiomyopathyLvL-PACENCT07534917
Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
An observational study of Pacemaker-Induced Cardiomyopathy and Tricuspid Regurgitation, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment of cardiac function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation, Right Ventricular Dysfunction
- What is being tested?
- Temporary left bundle branch area pacing and Temporary leadless right ventricular pacing
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Aug 2026to 1 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients referred for permanent pacemaker implantation with preserved LVEF at baseline.
Who may be able to join
- All patients aged ≥18 referred for a permanent pacemaker at a single centre (Guys and St. Thomas' NHS Foundation Trust, UK) with high degree AV block, including Mobitz II and complete heart block, or scheduled AV node ablation, and LVEF ≥50%.
Who cannot join
- LVEF <50%, severe TR, severe RV dysfunction, clinically unstable AV block requiring temporary pacing or isoprenaline infusion, left bundle branch block, previous TV annuloplasty or replacement, aortic valve replacement, life expectancy <1 year, end-stage renal failure, contraindication to cardiac MRI, CT or TOE, pregnancy, contraindication to anticoagulation, peripheral vascular disease precluding insertion of femoral catheters and insufficient capacity to consent to the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
St. Thomas' Hospital
London, SE1 7EH
Alphonsus Liew, MBBS
Aldo Rinaldi, MD
About this study
Official title: Left Bundle Branch Area Pacing Versus Right Ventricular Leadless Pacing: Acute Effects on Biventricular and Tricuspid Valve Function
Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment of cardiac function.
Newer pacemakers, such as leadless pacemakers and pacemakers that engage directly with the heart's native conduction system (known as left bundle branch pacemakers), are increasingly being adopted. However, the impact of these newer pacing technologies on cardiac function and the tricuspid valve, as well as how they compare with each other, remains unclear.
The investigators aim to study the impact of leadless pacemakers and left bundle branch pacemakers on cardiac function and the tricuspid valve by conducting an acute study in addition to the routine pacemaker implantation procedure for which participants have been referred. Both procedures will be performed during a single session under general anaesthesia. Outcomes from this study will improve understanding of how these pacing technologies affect cardiac and valvular function and how they compare with each other. These findings will help guide decision-making regarding the optimal type of pacemaker to adopt, particularly for patients at greatest risk of developing tricuspid valve dysfunction or impaired cardiac function.
Read the detailed description
Transvalvular right ventricular pacing (TVP) is a guideline-directed first-line treatment for high-degree AV block and sick sinus syndrome. However, TVP is associated with an increased risk of pacing-induced cardiomyopathy (PIM), tricuspid regurgitation (TR), and right ventricular dysfunction (RVD). Leadless right ventricular pacing (LP) and left bundle branch area pacing (LBBAP) are emerging as attractive alternatives to conventional TVP. While preliminary studies have investigated the impact of LP and LBBAP on left ventricular function, there is limited information on how these modalities compare with each other and their effects on right ventricular and tricuspid valve function. The investigators aim to perform an acute mechanistic study involving a head-to-head comparison of LBBAP and LP to evaluate their acute effects on biventricular and tricuspid valve function.
EXPERIMENTAL DETAILS AND DESIGN
Study design: Twenty patients will be prospectively recruited and undergo an acute mechanistic study during the same session prior to undergoing their allocated permanent pacemaker implantation, which will be performed according to standard clinical practice.
Study population
Inclusion criteria: Patients aged ≥18 years referred for permanent pacemaker implantation at a single centre (Guy's and St Thomas' NHS Foundation Trust, UK) with high-degree AV block, including Mobitz II and complete heart block, or scheduled for AV node ablation, and with LVEF ≥50%.
Exclusion criteria: LVEF <50%, severe TR, severe RV dysfunction, clinically unstable AV block requiring temporary pacing or isoprenaline infusion, left bundle branch block, previous tricuspid valve annuloplasty or replacement, aortic valve replacement, life expectancy <1 year, end-stage renal failure, contraindication to cardiac MRI, CT, or TOE, pregnancy, contraindication to anticoagulation, peripheral vascular disease precluding insertion of femoral catheters, or insufficient capacity to provide informed consent.
...
Meta-analysis: Studies comparing PIM rates between TVP and LP have yielded mixed results. As part of this fellowship, the investigator will also perform a systematic review and meta-analysis comparing the rates of PIM between LP and TVP to provide a more definitive assessment of whether LP is superior to TVP in reducing the incidence of PIM.
OUTCOME MEASURES AND STATISTICAL ANALYSIS
Hypothesis 1: There is a significant difference in the risk of acute PIM between LP and LBBAP.
Acute PIM will be assessed using TOE. A χ² test will be used to compare the proportion of acute PIM between the LBBAP and LP pacing configurations.
Hypothesis 2: LP is associated with a lower risk of acute TR progression compared with LBBAP.
Acute TR progression will be assessed using TOE by evaluating the degree of TR at baseline and during temporary pacing. A χ² test will be used to compare the proportion of TR progression between the LBBAP and LP pacing configurations.
Hypothesis 3: There is no significant difference in the risk of acute RVD between LP and LBBAP.
Acute RVD will be assessed using TOE by measuring TAPSE, RVEF, and RV GLS at baseline and during temporary pacing. Analysis of variance (ANOVA) will be used to compare the mean changes in TAPSE, RVEF, and RV GLS between the LBBAP and LP pacing configurations.
Mechanistic hypotheses
Hypothesis 4: LBBAP is associated with less electrical dyssynchrony compared with LP.
Electrical dyssynchrony will be assessed using ECGi by measuring VEU and LVDI at baseline and during the LBBAP and LP pacing configurations. ANOVA or the Kruskal-Wallis test will be used, depending on data distribution, to compare VEU and LVDI between the LBBAP and LP pacing configurations.
Hypothesis 5: LBBAP is associated with a higher rate of positive acute haemodynamic response than LP.
Acute haemodynamic response will be assessed using intracardiac pressure wires to measure LV dP/dt and RV dP/dt at baseline and during the LBBAP and LP pacing configurations. ANOVA will be used to compare LV dP/dt and RV dP/dt between the LBBAP and LP pacing configurations.
Hypothesis 6: There is no significant difference in activation times and electrical dyssynchrony measurements produced by in silico modelling and in vivo ECGi studies.
Activation times and electrical dyssynchrony will be compared between the in silico modelling and in vivo ECGi studies. Specifically, LVAT, BVAT, VEU, and LVDI will be compared between the two groups using the Student's t-test or Mann-Whitney U test, depending on data distribution.
- Being tested
- Temporary left bundle branch area pacing, Temporary leadless right ventricular pacing
- Keywords
- leadless pacemaker, left bundle branch area pacing, pacemaker-induced cardiomyopathy, tricuspid regurgitation, right ventricular dysfunction
- Medical subject headings
- Tricuspid Valve Insufficiency, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary left bundle branch area pacingOther
Temporary left bundle branch area pacing using a multielectrode catheter
Temporary leadless right ventricular pacingOther
Temporary leadless right ventricular pacing using multielectrode catheter
| Study group | Role | What they receive |
|---|---|---|
| Patients referred for permanent pacemaker implantation | All patients aged ≥18 referred for a permanent pacemaker at a single centre (Guys and St. Thomas' NHS Foundation Trust, UK) with high degree AV block, including Mobitz II and complete heart block, or scheduled AV node ablation, and LVEF ≥50%. Receives: Other: Temporary left bundle branch area pacing; Other: Temporary leadless right ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with acute pacemaker-induced cardiomyopathy
All patients will undergo intraprocedural transesophageal echocardiogram (TEE) and temporary left bundle branch area pacing (LBBAP) and leadless right ventricular pacing (LP). Measurements of left ventricular ejection fraction (LVEF) will be taken before and after each pacing configuration. A drop of >>10% in LVEF to an LVEF of <50% will be considered as acute pacing induced cardiomyopathy (PIM).
Measured: From the start of mechanistic study until the end of the mechanistic study (i.e. approximately 2 hours)
Secondary outcomes (2)
Proportion of patients with tricuspid regurgitation (TR) progression
We will measure acute TR progression with intraprocedural TEE by assessing the degree of TR at baseline and with temporary pacing.A TOE probe will be inserted into the oesophagus after induction of general anaesthesia. Quantitative measurements taken will include RV end systolic volume (RVESV), RV end diastolic volume (RVEDV), RV global longitudinal strain (GLS), RV free wall strain, 3D RVEF and if TR is present, vena contracta diameter and PISA. Qualitative measurements will include upper-oesophageal, mid-oesophageal and 'grasping' view of the TV with colour doppler. TR severity will be assessed using the British Society of Echocardiography (BSE) guidelines and will be graded by semiquantitative visual grading (grade 0: none/trace, 1: mild, 2: moderate, 3: moderate-to-severe, 4: severe)60. TR progression will be defined as an increase in 1 grade.
Measured: From the start of mechanistic study until the end of the mechanistic study (i.e. approximately 2 hours)
Proportion of patients with right ventricular dsyfunction
A TEE probe will be inserted into the oesophagus after induction of general anaesthesia. Quantitative measurements taken will include RV end systolic volume (RVESV), RV end diastolic volume (RVEDV), RV global longitudinal strain (GLS), RV free wall strain and 3D RVEF. We will assess for acute RVD with TOE by measuring TAPSE, RVEF, RV GLS at baseline and with temporary pacing.
Measured: From the start of mechanistic study until the end of the mechanistic study (i.e. approximately 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start18 Aug 2026
- Primary completion30 Jan 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker-Induced CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Aldo Rinaldi, MD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534917
- Sponsor's protocol ID
- 348341
- Acronym
- LvL-PACE
- Status last verified
- Aug 2026
- First submitted
- 10 Apr 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Bundle Branch Area Pacing Versus Right Ventricular Leadless Pacing: Acute Effects on Biventricular and Tricuspid Valve Function
- ClinicalTrials.gov ID
- NCT07534917
- Acronym / sponsor ID
- LvL-PACE / 348341
- Keywords
- leadless pacemaker, left bundle branch area pacing, pacemaker-induced cardiomyopathy, tricuspid regurgitation, right ventricular dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 16 Apr 2026 (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.
Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment of cardiac function.
Newer pacemakers, such as leadless pacemakers and pacemakers that engage directly with the heart's native conduction system (known as left bundle branch pacemakers), are increasingly being adopted. However, the impact of these newer pacing technologies on cardiac function and the tricuspid valve, as well as how they compare with each other, remains unclear.
The investigators aim to study the impact of leadless pacemakers and left bundle branch pacemakers on cardiac function and the tricuspid valve by conducting an acute study in addition to the routine pacemaker implantation procedure for which participants have been referred. Both procedures will be performed during a single session under general anaesthesia. Outcomes from this study will improve understanding of how these pacing technologies affect cardiac and valvular function and how they compare with each other. These findings will help guide decision-making regarding the optimal type of pacemaker to adopt, particularly for patients at greatest risk of developing tricuspid valve dysfunction or impaired cardiac function.
Detailed description
Transvalvular right ventricular pacing (TVP) is a guideline-directed first-line treatment for high-degree AV block and sick sinus syndrome. However, TVP is associated with an increased risk of pacing-induced cardiomyopathy (PIM), tricuspid regurgitation (TR), and right ventricular dysfunction (RVD). Leadless right ventricular pacing (LP) and left bundle branch area pacing (LBBAP) are emerging as attractive alternatives to conventional TVP. While preliminary studies have investigated the impact of LP and LBBAP on left ventricular function, there is limited information on how these modalities compare with each other and their effects on right ventricular and tricuspid valve function. The investigators aim to perform an acute mechanistic study involving a head-to-head comparison of LBBAP and LP to evaluate their acute effects on biventricular and tricuspid valve function.
EXPERIMENTAL DETAILS AND DESIGN
Study design: Twenty patients will be prospectively recruited and undergo an acute mechanistic study during the same session prior to undergoing their allocated permanent pacemaker implantation, which will be performed according to standard clinical practice.
Study population
Inclusion criteria: Patients aged ≥18 years referred for permanent pacemaker implantation at a single centre (Guy's and St Thomas' NHS Foundation Trust, UK) with high-degree AV block, including Mobitz II and complete heart block, or scheduled for AV node ablation, and with LVEF ≥50%.
Exclusion criteria: LVEF <50%, severe TR, severe RV dysfunction, clinically unstable AV block requiring temporary pacing or isoprenaline infusion, left bundle branch block, previous tricuspid valve annuloplasty or replacement, aortic valve replacement, life expectancy <1 year, end-stage renal failure, contraindication to cardiac MRI, CT, or TOE, pregnancy, contraindication to anticoagulation, peripheral vascular disease precluding insertion of femoral catheters, or insufficient capacity to provide informed consent.
...
Meta-analysis: Studies comparing PIM rates between TVP and LP have yielded mixed results. As part of this fellowship, the investigator will also perform a systematic review and meta-analysis comparing the rates of PIM between LP and TVP to provide a more definitive assessment of whether LP is superior to TVP in reducing the incidence of PIM.
OUTCOME MEASURES AND STATISTICAL ANALYSIS
Hypothesis 1: There is a significant difference in the risk of acute PIM between LP and LBBAP.
Acute PIM will be assessed using TOE. A χ² test will be used to compare the proportion of acute PIM between the LBBAP and LP pacing configurations.
Hypothesis 2: LP is associated with a lower risk of acute TR progression compared with LBBAP.
Acute TR progression will be assessed using TOE by evaluating the degree of TR at baseline and during temporary pacing. A χ² test will be used to compare the proportion of TR progression between the LBBAP and LP pacing configurations.
Hypothesis 3: There is no significant difference in the risk of acute RVD between LP and LBBAP.
Acute RVD will be assessed using TOE by measuring TAPSE, RVEF, and RV GLS at baseline and during temporary pacing. Analysis of variance (ANOVA) will be used to compare the mean changes in TAPSE, RVEF, and RV GLS between the LBBAP and LP pacing configurations.
Mechanistic hypotheses
Hypothesis 4: LBBAP is associated with less electrical dyssynchrony compared with LP.
Electrical dyssynchrony will be assessed using ECGi by measuring VEU and LVDI at baseline and during the LBBAP and LP pacing configurations. ANOVA or the Kruskal-Wallis test will be used, depending on data distribution, to compare VEU and LVDI between the LBBAP and LP pacing configurations.
Hypothesis 5: LBBAP is associated with a higher rate of positive acute haemodynamic response than LP.
Acute haemodynamic response will be assessed using intracardiac pressure wires to measure LV dP/dt and RV dP/dt at baseline and during the LBBAP and LP pacing configurations. ANOVA will be used to compare LV dP/dt and RV dP/dt between the LBBAP and LP pacing configurations.
Hypothesis 6: There is no significant difference in activation times and electrical dyssynchrony measurements produced by in silico modelling and in vivo ECGi studies.
Activation times and electrical dyssynchrony will be compared between the in silico modelling and in vivo ECGi studies. Specifically, LVAT, BVAT, VEU, and LVDI will be compared between the two groups using the Student's t-test or Mann-Whitney U test, depending on data distribution.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred for permanent pacemaker implantation | – | Other: Temporary left bundle branch area pacing, Other: Temporary leadless right ventricular pacingAll patients aged ≥18 referred for a permanent pacemaker at a single centre (Guys and St. Thomas' NHS Foundation Trust, UK) with high degree AV block, including Mobitz II and complete heart block, or scheduled AV node ablation, and LVEF ≥50%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred for permanent pacemaker implantation with preserved LVEF at baseline.
Key inclusion criteria (1 listed)
- All patients aged ≥18 referred for a permanent pacemaker at a single centre (Guys and St. Thomas' NHS Foundation Trust, UK) with high degree AV block, including Mobitz II and complete heart block, or scheduled AV node ablation, and LVEF ≥50%.
Key exclusion criteria (1 listed)
- LVEF <50%, severe TR, severe RV dysfunction, clinically unstable AV block requiring temporary pacing or isoprenaline infusion, left bundle branch block, previous TV annuloplasty or replacement, aortic valve replacement, life expectancy <1 year, end-stage renal failure, contraindication to cardiac MRI, CT or TOE, pregnancy, contraindication to anticoagulation, peripheral vascular disease precluding insertion of femoral catheters and insufficient capacity to consent to the study.
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 |
|---|---|---|
| Temporary left bundle branch area pacingTemporary left bundle branch area pacing using a multielectrode catheter | Other | Patients referred for permanent pacemaker implantation |
| Temporary leadless right ventricular pacingTemporary leadless right ventricular pacing using multielectrode catheter | Other | Patients referred for permanent pacemaker implantation |
Primary outcome
Proportion of patients with acute pacemaker-induced cardiomyopathy
Time frame: From the start of mechanistic study until the end of the mechanistic study (i.e. approximately 2 hours)
All patients will undergo intraprocedural transesophageal echocardiogram (TEE) and temporary left bundle branch area pacing (LBBAP) and leadless right ventricular pacing (LP). Measurements of left ventricular ejection fraction (LVEF) will be taken before and after each pacing configuration. A drop of >>10% in LVEF to an LVEF of <50% will be considered as acute pacing induced cardiomyopathy (PIM).
2 secondary outcomes
Proportion of patients with tricuspid regurgitation (TR) progression
Time frame: From the start of mechanistic study until the end of the mechanistic study (i.e. approximately 2 hours)
Proportion of patients with right ventricular dsyfunction
Time frame: From the start of mechanistic study until the end of the mechanistic study (i.e. approximately 2 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- 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.
Aldo Rinaldi, MD principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker-Induced Cardiomyopathy and Tricuspid Regurgitation, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 1 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: looking for participants now, as of the sponsor's last update on 21 Aug 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aldo Rinaldi, MD (+44207 188 9275, aldo.rinaldi@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with acute pacemaker-induced cardiomyopathy (time frame: From the start of mechanistic study until the end of the mechanistic study (i.e. approximately 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.