Solutions to the Challenges of Conduction System Pacing

NCT07009834 | Recruiting

• 1 other identifier: 23HH8267
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Conduction System Pacing; Pacing Therapy

Keywords

Challenges of conduction system pacing; CSA

Outcome Measures

Primary Outcomes (2)

• A1: Success rates of conduction system lead implant (novel workflow vs conventional methods)

  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

  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

  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

  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

  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.

  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

  From enrollment until 6 months after recruitment of last patient

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from London who are attending Hammermsith Hospital for device therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare Trust; Hammersmith Hospital

London, W12 0HS, United Kingdom

RECRUITING

Study Officials

• Whinnett, BM.BS

  Imperial College London, Imperial College Healthcare Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akriti Naraen, MBChB

CONTACT

+91203-31-31000; a.naraen@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: June 8, 2025
• Study Start: November 6, 2023
• Primary Completion (Estimated): November 6, 2026
• Study Completion (Estimated): November 6, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

GB (1)