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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust
RECRUITING
London
Contact Information
Primary
Jack W Samways, MBChB, MRes, MRCP
jsamways@ic.ac.uk
+4420 331 33000
Time Frame
Start Date: 2025-11-12
Estimated Completion Date: 2028-10-24
Participants
Target number of participants: 60
Treatments
Active_comparator: Biventricular pacing
Current standard of care cardiac resynchronisation therapy with biventricular pacing (one lead to right ventricular endocardium and one lead to left ventricular epicardium, accessed via the coronary sinus).
Experimental: Conduction system pacing
Cardiac 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.
Experimental: Left bundle optimised cardiac resynchronisation therapy (LOT-CRT)
Cardiac 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).
Related Therapeutic Areas
Sponsors
Collaborators: Imperial College Healthcare NHS Trust
Leads: Imperial College London

This content was sourced from clinicaltrials.gov