Conduction System PacingCSANCT07009834
Solutions to the Challenges of Conduction System Pacing
An observational study of Conduction System Pacing and Pacing Therapy, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Conduction system pacing is a new way of stimulating the heart using pacemaker wires. Traditional pacemakers stimulate the heart muscle which causes disordered heart beats: the walls of the heart move at different times. This wears down the heart over time. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Conduction System Pacing, Pacing Therapy
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Nov 2023to 6 Nov 2026
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from London who are attending Hammermsith Hospital for device therapy.
Who may be able to join
- Patients with a ventricular pacing indication: high grade atrioventricular block and symptomatic trifasicular, bifasicular block or left bundle branch block LBBB for cardiac resynchronisation therapy
- Adults willing to take part (ages 18 - 100 years old)
- Able to give consent.
Who cannot join
- Unable to give consent
- Children age < 18 years and adults > 100 years old
- Pregnant patients As per standard of care, female patients of child-bearing age will have a urine pregnancy test prior to their procedure.
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
Imperial College Healthcare Trust; Hammersmith Hospital
London, W12 0HS
Akriti Naraen, MBCHb, a.naraen@imperial.ac.uk
Zachary Whinnett, BM.BS
About this study
Conduction system pacing is a new way of stimulating the heart using pacemaker wires. Traditional pacemakers stimulate the heart muscle which causes disordered heart beats: the walls of the heart move at different times. This wears down the heart over time.
Conduction system pacemakers stimulate the heart's electrical system directly producing natural heart beats that are much less disordered. Unfortunately, these pacemakers can only be implanted by a small group of experts at specialised centres with specialist equipment. This study aims to allow conduction system pacemakers to be offered to any patient at any hospital by simplifying the process of inserting the pacemaker wires and the improving the pacemaker's ability to interpret electrical traces.
Firstly, the best locations in the heart for conduction system pacemaker wires using specialised electrical traces, MRI and ultrasound scans will be identified. Features that can be seen on X-ray to guide doctors to these locations will then be identified. Secondly, the investigators will collect electrical information from the pacemaker wires and additional electrical traces to develop an algorithm that can make the interpretation the electrical traces more accurate.
Read the detailed description
Study A:
100 patients will be prospectively recruited. These patients will be further divided into a derivation and validation group. The derivation group will consist of the first fifty patients recruited (patients 1-50) and the validation group will consist the second fifty patients recruited (patients 51-100).
All 100 patients will have an indication for pacemaker insertion and will undergo a conduction system pacemaker implant.
The derivation group will undergo the research protocol which will include additional measurements from:
- Ultra-high frequency ECG. A non-invasive surface ECG that detects, isolates and amplifies high frequency components that are filtered out in conventional ECGs.
- Electro-anatomical mapping. In majority of participants, the invasive mapping catheter will be inserted from the same venous access point to collect detailed electrical and anatomical data. In a small subset of patients, activation maps of the left ventricle will be collected, where the access will be through the femoral artery in the groin. Non invasive mapping will also be performed in a subgroup of patients with ECGi, where the participants will wear a 252 electrode ECG vest during the procedure. These patients will undergo a pre-procedural CT scan with the vest.
- Echocardiography. Participants will undergo either transthoracic echocardiography, transoesophageal echocardiography or intracardiac echocardiography. Additional venous access from the femoral vein in the groin will be sought for patients undergoing intracardiac echocardiography.
- Haemodynamic assessment Invasive blood pressure will be obtained in patients who already have arterial access for the left ventricular electro- anatomical maps. The sheath will be connected to the pressure inducer. Non invasive beat-by-beat blood pressure will be obtained by a high precision finger cuff (finometer).
A further 50 patients will be prospectively recruited that will make up the validation cohort for Study A. These patients will undergo a conduction system pacemaker as standard clinical practice. The step-by-step algorithm will be prospectively derived from the above to implant the conduction system lead using standard equipment alone; fluoroscopy, PSA and 12-lead ECG. The success rate, conduction system capture threshold, procedure time and fluoroscopy time will be assessed. Although all operators will be highly experienced device implanters, these implants will include operators who are new to conduction system lead implantation.
Study B:
In patients 1-50 undergoing implantation of conduction system pacemakers, 2-lead surface ECG alongside conventional lead data will be collected. A surface 12-lead ECG will be collected as well. The patients will undergo the standard pacing manoeuvres for conduction system pacing. The patient will be paced using the PSA and a 12-lead ECG and 2-lead ECG will be collected via Bard, a computer software that is able to collect highly accurate ECG traces of the heart using mapping catheters placed inside the heart and the surface ECG.
Prospective data from 200 patients with a chronic conduction system lead implant under device follow-up to obtain EGM, 12 -lead ECG and the 2-lead ECG recordings of multiple pacing and sensing configurations will also be collected. These patients will be attending for routine appointments. The pacing and sensing configurations are undertaken as part of routine checks
- Conditions
- Conduction System Pacing, Pacing Therapy
- Keywords
- Challenges of conduction system pacing, CSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Derivation | These patients will undergo the research protocol. In these patients, the investigators will attempt to implant a permanent conduction system pacing lead, in lieu of the RV or LV lead. The lead will be implanted by operators who have implanted more than 40 leads to overcome the learning curve. | |
| Validation | These patients will undergo a conduction system pacemaker as standard clinical practice. The implanters will prospectively apply the step-by-step algorithm derived above to implant the conduction system lead using standard equipment alone; fluoroscopy, PSA and 12-lead ECG. The investigators will assess the success rate, conduction system capture threshold, procedure time and fluoroscopy time. Although all operators will be highly experienced device implanters, these implants will include operators who are new to conduction system lead implantation. | |
| 2-lead ECG group | Patients with a chronic conduction system lead implant under device follow-up will under go 2-lead ECG of multiple pacing and sensing configurations. These patients will be attending for routine appointments. The pacing and sensing configurations are undertaken as part of routine checks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1: Success rates of conduction system lead implant (novel workflow vs conventional methods)
Measured: From enrollment until 6 months after recruitment of last patient
B1: The number of patients with morphology change seen during decrementing output threshold test of 2-lead ECG when compared to gold standard 12-lead ECG
Measured: From enrollment until 6 months after recruitment of last patient
Secondary outcomes (5)
A2: Procedure and fluoroscopy times of the streamlined workflow to current conventional methods of His-bundle and Left-bundle pacing
Measured: From enrolment to until completion of PPM insertion of the last patient recruited into Study A (patient 100); average total of 3 years
A2: Procedure and fluoroscopy times of the streamlined workflow of conduction system implant to current right ventricular pacing
Measured: From enrolment to until completion of PPM insertion of the last patient recruited into Study A (patient 100); average total of 3 years
A2: Assess capture threshold of conduction system pacing from the optimised workflow to that of conventional methods of conduction system implantation
Threshold is measured through the device, looking to achieve the minimum energy (in V) required to safely and reliably capture the cardiac tissue target. In this outcome, the investigators will compare the minimum threshold required to achieve capture of conduction system pacing to that of conventional right ventricular pacing and asses if this the same, higher or lower.
Measured: From enrollment until 6 months after recruitment of last patient
A2: Define left bundle area capture diagnostics and delineate differences between left ventricular septal pacing.
Measured: From enrollment until 6 months after recruitment of last patient
B2: Improvement in device battery life measured in days and months with novel device algorithm applied
Device battery time is given upon device interrogation and is dependent on percentage of the time the patient is paced and the energy delivered. Battery life will increase if less energy is required. The investigators will assess if there is a increase in days or months in the battery life of the pacemaker with introduction of the novel algorithm.
Measured: From enrollment until 6 months after recruitment of last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start6 Nov 2023
- Primary completion6 Nov 2026 (estimated)
- Study completion6 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduction System PacingStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Whinnett, BM.BS, Principal investigator, Imperial College London, Imperial College Healthcare Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009834
- Sponsor's protocol ID
- 23HH8267
- Acronym
- CSA
- Status last verified
- Jul 2025
- First submitted
- 7 May 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solutions to the Challenges of Conduction System Pacing
- ClinicalTrials.gov ID
- NCT07009834
- Acronym / sponsor ID
- CSA / 23HH8267
- Conditions
- Conduction System Pacing, Pacing Therapy
- Keywords
- Challenges of conduction system pacing, CSA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 6 Nov 2026 (estimated)
- Study completion
- 6 Nov 2026 (estimated)
- First posted
- 8 Jun 2025 (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.
Conduction system pacing is a new way of stimulating the heart using pacemaker wires. Traditional pacemakers stimulate the heart muscle which causes disordered heart beats: the walls of the heart move at different times. This wears down the heart over time.
Conduction system pacemakers stimulate the heart's electrical system directly producing natural heart beats that are much less disordered. Unfortunately, these pacemakers can only be implanted by a small group of experts at specialised centres with specialist equipment. This study aims to allow conduction system pacemakers to be offered to any patient at any hospital by simplifying the process of inserting the pacemaker wires and the improving the pacemaker's ability to interpret electrical traces.
Firstly, the best locations in the heart for conduction system pacemaker wires using specialised electrical traces, MRI and ultrasound scans will be identified. Features that can be seen on X-ray to guide doctors to these locations will then be identified. Secondly, the investigators will collect electrical information from the pacemaker wires and additional electrical traces to develop an algorithm that can make the interpretation the electrical traces more accurate.
Detailed description
Study A:
100 patients will be prospectively recruited. These patients will be further divided into a derivation and validation group. The derivation group will consist of the first fifty patients recruited (patients 1-50) and the validation group will consist the second fifty patients recruited (patients 51-100).
All 100 patients will have an indication for pacemaker insertion and will undergo a conduction system pacemaker implant.
The derivation group will undergo the research protocol which will include additional measurements from:
- Ultra-high frequency ECG. A non-invasive surface ECG that detects, isolates and amplifies high frequency components that are filtered out in conventional ECGs.
- Electro-anatomical mapping. In majority of participants, the invasive mapping catheter will be inserted from the same venous access point to collect detailed electrical and anatomical data. In a small subset of patients, activation maps of the left ventricle will be collected, where the access will be through the femoral artery in the groin. Non invasive mapping will also be performed in a subgroup of patients with ECGi, where the participants will wear a 252 electrode ECG vest during the procedure. These patients will undergo a pre-procedural CT scan with the vest.
- Echocardiography. Participants will undergo either transthoracic echocardiography, transoesophageal echocardiography or intracardiac echocardiography. Additional venous access from the femoral vein in the groin will be sought for patients undergoing intracardiac echocardiography.
- Haemodynamic assessment Invasive blood pressure will be obtained in patients who already have arterial access for the left ventricular electro- anatomical maps. The sheath will be connected to the pressure inducer. Non invasive beat-by-beat blood pressure will be obtained by a high precision finger cuff (finometer).
A further 50 patients will be prospectively recruited that will make up the validation cohort for Study A. These patients will undergo a conduction system pacemaker as standard clinical practice. The step-by-step algorithm will be prospectively derived from the above to implant the conduction system lead using standard equipment alone; fluoroscopy, PSA and 12-lead ECG. The success rate, conduction system capture threshold, procedure time and fluoroscopy time will be assessed. Although all operators will be highly experienced device implanters, these implants will include operators who are new to conduction system lead implantation.
Study B:
In patients 1-50 undergoing implantation of conduction system pacemakers, 2-lead surface ECG alongside conventional lead data will be collected. A surface 12-lead ECG will be collected as well. The patients will undergo the standard pacing manoeuvres for conduction system pacing. The patient will be paced using the PSA and a 12-lead ECG and 2-lead ECG will be collected via Bard, a computer software that is able to collect highly accurate ECG traces of the heart using mapping catheters placed inside the heart and the surface ECG.
Prospective data from 200 patients with a chronic conduction system lead implant under device follow-up to obtain EGM, 12 -lead ECG and the 2-lead ECG recordings of multiple pacing and sensing configurations will also be collected. These patients will be attending for routine appointments. The pacing and sensing configurations are undertaken as part of routine checks
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Derivation | – | –These patients will undergo the research protocol. In these patients, the investigators will attempt to implant a permanent conduction system pacing lead, in lieu of the RV or LV lead. The lead will be implanted by operators who have implanted more than 40 leads to overcome the learning curve. |
| Validation | – | –These patients will undergo a conduction system pacemaker as standard clinical practice. The implanters will prospectively apply the step-by-step algorithm derived above to implant the conduction system lead using standard equipment alone; fluoroscopy, PSA and 12-lead ECG. The investigators will assess the success rate, conduction system capture threshold, procedure time and fluoroscopy time. Although all operators will be highly experienced device implanters, these implants will include operators who are new to conduction system lead implantation. |
| 2-lead ECG group | – | –Patients with a chronic conduction system lead implant under device follow-up will under go 2-lead ECG of multiple pacing and sensing configurations. These patients will be attending for routine appointments. The pacing and sensing configurations are undertaken as part of routine checks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from London who are attending Hammermsith Hospital for device therapy.
Key inclusion criteria (3 listed)
- Patients with a ventricular pacing indication: high grade atrioventricular block and symptomatic trifasicular, bifasicular block or left bundle branch block LBBB for cardiac resynchronisation therapy
- Adults willing to take part (ages 18 - 100 years old)
- Able to give consent.
Key exclusion criteria (3 listed)
- Unable to give consent
- Children age < 18 years and adults > 100 years old
- Pregnant patients As per standard of care, female patients of child-bearing age will have a urine pregnancy test prior to their procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A1: Success rates of conduction system lead implant (novel workflow vs conventional methods)
Time frame: From enrollment until 6 months after recruitment of last patient
B1: The number of patients with morphology change seen during decrementing output threshold test of 2-lead ECG when compared to gold standard 12-lead ECG
Time frame: From enrollment until 6 months after recruitment of last patient
5 secondary outcomes
A2: Procedure and fluoroscopy times of the streamlined workflow to current conventional methods of His-bundle and Left-bundle pacing
Time frame: From enrolment to until completion of PPM insertion of the last patient recruited into Study A (patient 100); average total of 3 years
A2: Procedure and fluoroscopy times of the streamlined workflow of conduction system implant to current right ventricular pacing
Time frame: From enrolment to until completion of PPM insertion of the last patient recruited into Study A (patient 100); average total of 3 years
A2: Assess capture threshold of conduction system pacing from the optimised workflow to that of conventional methods of conduction system implantation
Time frame: From enrollment until 6 months after recruitment of last patient
A2: Define left bundle area capture diagnostics and delineate differences between left ventricular septal pacing.
Time frame: From enrollment until 6 months after recruitment of last patient
B2: Improvement in device battery life measured in days and months with novel device algorithm applied
Time frame: From enrollment until 6 months after recruitment of last patient
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 14 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Whinnett, BM.BS principal investigator
Imperial College London, Imperial College Healthcare 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 Conduction System Pacing and Pacing Therapy, run by Imperial College London 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 3 inclusion and 3 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 14 Jul 2025. 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 Akriti Naraen, MBChB (+91203-31-31000, a.naraen@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A1: Success rates of conduction system lead implant (novel workflow vs conventional methods) (time frame: From enrollment until 6 months after recruitment of last patient). 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?
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 14 Jul 2025.