Investigating new pacing methods for heart failure patients
Direct HIS/LBB Pacing as an Alternative to Biventricular Pacing in Patients With Symptomatic Heart Failure Despite Optimal Medical Treatment and ECG With Typical Left Bundle Branch Block
This study is testing new pacing methods for heart failure patients to see if they can work better than the usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College Healthcare NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05814263 on ClinicalTrials.gov |
What this trial studies
This study explores the feasibility of using direct HIS pacing or left bundle branch pacing as alternatives to traditional biventricular pacing in patients suffering from symptomatic heart failure with a left bundle branch block pattern on their ECG. It aims to randomize 125 patients to either conventional cardiac resynchronization therapy (CRT) or the new pacing methods, assessing their effectiveness in improving heart function. The study will evaluate the pacing thresholds and overall outcomes to determine if these alternatives can provide better results than the standard approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with ischemic or non-ischemic cardiomyopathy, LVEF ≤ 35%, and NYHA class II-IV heart failure symptoms despite optimal medical treatment.
Not a fit: Patients who do not have a typical left bundle branch block pattern or those with existing biventricular pacing systems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart function and quality of life for patients with heart failure.
How similar studies have performed: While traditional biventricular pacing has been the standard, recent studies on direct HIS and left bundle branch pacing have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years of age, ischemic or non-ischemic cardiomyopathy with LVEF ≤ 35% assessed by echocardiography, NYHA class II-IV heart failure symptoms despite optimal medical treatment and * Either planned new implantation of a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block (see definition below) * Or planned upgrade of an existing pacemaker or ICD to a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block or there has been\> 90% right ventricular pacing from an existing pacemaker for at least 2 months prior to enrollment * Signed informed consent * Typical left bundle branch block: * QRS width \> 130 msec for women and \> 140 msec for men QS or rS pattern in leads V1 and V2, and mid-QRS plateau phase with or without extras in at least 2 of leads V1, V2, V5, V6, I, and aVL Exclusion Criteria: * Existing biventricular pacing system * Permanent atrial fibrillation * Severe renal failure with eGFR \< 30 ml/min * AMI or CABG within the last three months * The patient does not want to participate
Where this trial is running
London
- Hammersmith Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Daniel Keene, MBChB
- Email: daniel.keene@nhs.net
- Phone: 020 3313 1000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.