Ablation and pacing for patients with atrial fibrillation
Safety and Efficacy of Distal His Bundle Pacing Compared to Right Ventricular Pacing in Patients With Symptomatic Atrial Fibrillation Undergoing AV Node Ablation With Evidence of Heart Failure, a Randomised Control Study
This study is testing whether a new type of heart pacing can help people with atrial fibrillation feel better compared to traditional pacing after they have a procedure to control their heart rhythm.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospitals, Leicester Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT06152406 on ClinicalTrials.gov |
What this trial studies
The Ablate and Pace HIS Study is a prospective randomized trial focusing on patients with symptomatic atrial fibrillation who are not suitable for rhythm control strategies. It aims to compare the outcomes of traditional right ventricular pacing against HIS bundle pacing in patients undergoing AV node ablation and pacemaker implantation. A total of 100 participants will be randomized into two groups, with endpoint measurements taken at multiple time points to assess the effectiveness of HIS pacing. The study is designed to be double-blinded to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with symptomatic atrial fibrillation who are not suitable for rhythm control strategies and require AV node ablation.
Not a fit: Patients who already have a pacemaker or those with severe left ventricular systolic dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life for patients with atrial fibrillation by providing a more effective pacing strategy.
How similar studies have performed: Previous studies have shown promising results with HIS bundle pacing, indicating potential benefits over traditional pacing methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 or above * Symptomatic AF, New York Heart Association (NYHA) class II-IV * Willing to consent for the study * AF regardless type, deemed not suitable for rhythm control strategy that has been referred for AVN ablation with one of the following: 1. Impaired LV function, EF \<50 %. And or 2. Raised N-Terminal Pro B-type Natriuretic Peptide ( NT-ProBNP) \>365 ng/L Exclusion Criteria: * Patient who has already got a pacemaker in situ * Known severe LVSD when biventricular device is the thought to be the preferred pacing modality * Females in child bearing period * Lack of capacity to consent * Other serious medical condition with life expectancy of less than 1 year * Less than 18 years * Unwilling to consent for the study
Where this trial is running
Leicester, Leicestershire
- University Hospitals of Leicester NHS Trust — Leicester, Leicestershire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Mokhtar Ibrahim, Dr
- Email: mokhtar.ibrahim@uhl-tr.nhs.uk
- Phone: 0116 2583887
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.