Actively Recruiting
Solutions to the Challenges of Conduction System Pacing
Led by Imperial College London · Updated on 2025-07-14
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying conduction system pacing, a new method of stimulating the heart's electrical system directly to produce more natural heartbeats. This approach is compared to traditional pacemakers which stimulate the heart muscle and can cause disordered heartbeats that wear down the heart over time. The study aims to simplify the process of inserting conduction system pacemaker wires so that this treatment can be offered more widely at any hospital, not just specialized centers. It also seeks to improve the pacemaker's ability to interpret electrical signals from the heart. The study involves 100 patients who need a pacemaker and will receive conduction system pacemaker implants. The first 50 patients undergo additional tests including ultra-high frequency ECG, electro-anatomical mapping, echocardiography, and blood pressure assessments to identify the best wire locations in the heart. The next 50 patients will have their pacemakers implanted using a step-by-step algorithm developed from earlier data, using standard equipment and including operators new to this implant technique. Another group of 200 patients with chronic conduction system leads will have ECG recordings taken during routine follow-ups to analyze pacing and sensing configurations. Participants will undergo imaging scans such as MRI, CT, and ultrasound, electrical measurements, and routine follow-up visits. The study measures success rates of the new implant method compared to conventional methods, procedure and fluoroscopy times, pacemaker capture thresholds, and device battery life improvements. Data collection continues until six months after the last patient is recruited, with safety and effectiveness monitored throughout the study period, which lasts about three years.
CONDITIONS
Brief Title
Solutions to the Challenges of Conduction System Pacing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a ventricular pacing indication such as high grade atrioventricular block, symptomatic trifascicular or bifascicular block, or left bundle branch block for cardiac resynchronization therapy
- Adults aged 18 to 100 years old
- Able and willing to give consent to participate
You will not qualify if you...
- Unable to give consent
- Children under 18 years old and adults over 100 years old
- Pregnant patients (female patients of child-bearing age will have a urine pregnancy test before the procedure)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure time varies, averaging up to 3 years from enrollment to completion of all implants
Participants undergo conduction system pacemaker implantation. The derivation group will have additional research procedures including ultra-high frequency ECG, electro-anatomical mapping, echocardiography, and haemodynamic assessments. The validation group will receive the pacemaker implant using a step-by-step algorithm with standard clinical equipment.
1 implantation visit (in-person)
Duration - Up to 6 months after recruitment of last patient
Participants with chronic conduction system leads undergo routine device follow-up appointments including 2-lead ECG and 12-lead ECG recordings to assess pacing and sensing configurations. In the derivation group, pacing maneuvers with ECG data collection occur during implantation.
Routine follow-up visits as per clinical care
Trial Site Locations
Total: 1 location
1
Imperial College Healthcare Trust; Hammersmith Hospital
London, United Kingdom, W12 0HS
Actively Recruiting
Research Team
A
Akriti Naraen, MBChB
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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