Comparing Three Types of Specialist Pacemakers to Improve Heart Function and Reduce Rhythm Problems in Heart Failure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorImperial College London

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Unable to provide informed consent

<18 years old

Pregnant patients (with female patients of childbearing age requiring a negative urine BHCG)

Trial design

Treatments tested in this trial

  • Biventricular pacing
  • Conduction system pacing
  • Left bundle optimised cardiac resynchronisation therapy

Treatment groups

60 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Imperial College London

Lead sponsor

Imperial College Healthcare NHS Trust

Collaborator