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

Official title

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

Overview

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.

Interventions

• Device Biventricular pacing
  Cardiac resynchronisation therapy with one lead to right ventricular endocardium and one lead to left ventricular epicardium, accessed via the coronary sinus.
• Device 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. 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.
• Device Left bundle optimised cardiac resynchronisation therapy
  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).

Primary outcome measures

• Primary outcome: Daily ordinal symptom score with clinical over-rides [Time frame: From randomisation to 6-months post device implant]
• Primary arrhythmia outcome [Time frame: From randomisation to 6-months post device implant]
• Primary contractility outcome [Time frame: From randomisation to 6-months post device implant]

Secondary outcome measures (12)

• Rate of death [Time frame: From randomisation up to 36 months, or death from any cause, whichever came first.]
• Number of participants with intractable symptoms leading to trial exit/unblinding [Time frame: From randomisation up to 36 months, or intractable symptoms leading to trial exit/unblinding, whichever came first.]
• Rate of heart failure hospitalisation [Time frame: From randomisation up to 36 months]
• Rate of non-heart failure hospitalisation [Time frame: From randomisation up to 36 months]
• Rate of appropriate implantable cardioverter defibrillator device therapy [Time frame: From randomisation up to 36 months]
• Daily heart failure symptom score [Time frame: From randomisation up to 36 months]
• Rate of sustained ventricular arrhythmia [Time frame: From randomisation up to 36 months]
• Rate of sustained atrial arrhythmia [Time frame: From randomisation up to 36 months]
• Rate of non-sustained ventricular arrhythmia [Time frame: From randomisation up to 36 months]
• Number of participants with >10% ventricular ectopy on 24h ECG [Time frame: At 12-weeks post implant]
• Left ventricular ejection fraction (LVEF) [Time frame: From baseline echocardiogram (pre device implant) to follow-up echocardiogram (at 6 months)]
• Left ventricular repolarisation heterogeneity [Time frame: From implant to 6-months]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• Hammersmith Hospital, Imperial College Healthcare NHS Trust — London

Identifiers

NCT: NCT07430553 · 172375 · FS/CRTF/25/24768

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗