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

Sponsor: Imperial College London

NCT ID: NCT07430553

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Biventricular pacing (device), Conduction system pacing (device), Left bundle optimised cardiac resynchronisation therapy (device)
How long the study runs
Study runs about 35 months (dates as stated)
About the drug or intervention
Biventricular pacing — device: Cardiac resynchronisation therapy with one lead to right ventricular endocardium and one lead to left ventricular epicardium, accessed via the coronary sinus. · Conduction system pacing — device: Cardiac resynchronisation therapy with single lead targeting direct capture of the conduction system. · Left bundle optimised cardiac resynchronisation therapy — device: Cardiac resynchronisation therapy delivered by conduction system optimised hybrid configurations.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
60
Started
2025-11-12
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure and reduced ejection fraction
  • • NA - 60 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with heart failure and reduced ejection fraction

Where?

  • • London - Hammersmith Hospital, Imperial College Healthcare NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Heart Failure and Reduced Ejection FractionDyssynchrony

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

requiring a negative

What the study is looking for

  • ✓Patients referred/scheduled for a CRT procedure (new implant or upgrade) who have:
  • ✓causing symptoms 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)...
  • ✓Optimal medical therapy for HF

Who cannot take part

  • ✗Unable to provide agreement to take part
  • ✗\<18 years old
  • ✗Pregnant patients (with female patients of childbearing age requiring a negative urine BHCG)
See the full criteria
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 Is This Study? (1 UK site)

Hammersmith Hospital, Imperial College Healthcare NHS Trust

London W12 0HS, United Kingdom

Recruiting
Site contact (verified)
Zachary I Whinnett, BMBS BMEDSCI MRCP PhDPrincipal Investigator
Jack W Samways, MBChB MRes (Merit) MRCP(UK)+44 (0) 20 3311 3311jsamways@ic.ac.uk
Ahran D Arnold, MBBS BSc MSc MRCP PhD+44 (0) 20 3311 3311ada104@ic.ac.uk

How to Get in Touch

Jack W Samways, MBChB, MRes, MRCP

Sponsor contact

CONTACT

+4420 331 33000 jsamways@ic.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-02