Comparing Three Types of Specialist Pacemakers to Improve Heart Function and Reduce Rhythm Problems in Heart Failure
Recruiting · NCT07430553 · Interventional (participants receive a specific treatment) · Lead sponsor: Imperial College London
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to find out which type of specialist pacemaker-known as cardiac resynchronisation therapy (CRT)-works best for people with heart failure and a delay in how the lower chambers of the heart beat together (called electrical dyssynchrony). The main aims of the study are: To compare the effects of conventional biventricular pacing (BVP), conduction system pacing (CSP) and left-bundle optimised CRT (LOT-CRT) on heart failure symptoms and heart rhythm problems over six months. To explore how these pacing methods affect heart muscle strength, electrical activity, and overall heart function. Participants will: Attend four hospital visits over a six-month period. At Visit 1, meet a member of the research team to discuss the study and have screening tests to check eligibility. Participants will also have a smartphone app installed and receive training on how to record their daily heart failure symptoms. At Visit 2, have a CRT pacemaker implanted. The type of pacemaker will be chosen at random, with a 1 in 3 chance of receiving: * Biventricular pacing (BVP); the current standard treatment * Conduction system pacing (CSP) * LOT-CRT (Left-bundle optimised CRT); a combination of both At Visit 3 (around 12 weeks after implantation) and Visit 4 (6 months after implantation), take part in routine follow-up assessments to check the pacemaker and heart function. At Visits 2 and 4, also undergo non-invasive electrical mapping tests, including wearing a specialised vest and having a low-dose CT scan of the chest. These tests help researchers understand how the heart's electrical system responds to different pacing methods.
Who can take part
Inclusion criteria
- Patients referred/scheduled for a CRT procedure (new implant or upgrade) who have:
- Symptomatic heart failure (NYHA II-IV)
- Reduced ejection fraction (LVEF≤40%)
- Prolonged QRS duration (≥130ms) and left bundle branch block ECG morphology or very prolonged QRS duration (\>150ms) and non-left bundle branch block ECG
- Optimal medical therapy for HF
Exclusion criteria
- Unable to provide informed consent
- \<18 years old
- Pregnant patients (with female patients of childbearing age requiring a negative urine BHCG)
Where it is running
1 location listed.
- Hammersmith Hospital, Imperial College Healthcare NHS Trust - London, Greater London, United Kingdom