NCT07009834 Solutions to the Challenges of Conduction System Pacing
| NCT ID | NCT07009834 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Conduction System Pacing |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-11-06 |
| Primary Completion | 2026-11-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-11-06 with a primary completion date of 2026-11-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. 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 2. Adults willing to take part (ages 18 - 100 years old) 3. Able to give consent. Exclusion Criteria: 1. Unable to give consent 2. Children age \< 18 years and adults \> 100 years old 3. Pregnant patients As per standard of care, female patients of child-bearing age will have a urine pregnancy test prior to their procedure.
Contact & Investigator
Whinnett, BM.BS
PRINCIPAL INVESTIGATOR
Imperial College London, Imperial College Healthcare Trust
Frequently Asked Questions
Who can join the NCT07009834 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Conduction System Pacing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07009834 currently recruiting?
Yes, NCT07009834 is actively recruiting participants. Contact the research team at a.naraen@imperial.ac.uk for enrollment information.
Where is the NCT07009834 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07009834 clinical trial?
NCT07009834 is sponsored by Imperial College London. The principal investigator is Whinnett, BM.BS at Imperial College London, Imperial College Healthcare Trust. The trial plans to enroll 300 participants.