Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07430553

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

Randomised Investigation of Physiological, Conventional and Optimised Resynchronisation Therapy in Heart Failure With Prolonged QRS Duration (RIPCORD-CRT)

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Imperial College London · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEBiventricular pacingCardiac resynchronisation therapy with one lead to right ventricular endocardium and one lead to left ventricular epicardium, accessed via the coronary sinus.
DEVICEConduction system pacingCardiac resynchronisation therapy with single lead targeting direct capture of the conduction system. Primary target should be left bundle area, with backup target of His bundle. If direct capture of the conduction system cannot be achieved by conventional clinical criteria, left septal pacing targeted at the left bundle branch area will be accepted.
DEVICELeft bundle optimised cardiac resynchronisation therapyCardiac resynchronisation therapy delivered by conduction system optimised hybrid configurations. Primary configuration should be conduction system pacing lead targeted at the left bundle area combined with left ventricular epicardial lead accessed via the coronary sinus (LOT-CRT). Backup configuration of conduction system pacing lead targeted at the His bundle combined with left ventricular epicardial lead accessed via the coronary sinus (HOT-CRT).

Timeline

Start date
2025-11-12
Primary completion
2028-10-24
Completion
2028-10-24
First posted
2026-02-24
Last updated
2026-02-24

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT07430553. Inclusion in this directory is not an endorsement.