Actively Recruiting
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
Led by University Hospitals, Leicester · Updated on 2026-01-05
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospitals, Leicester
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Atrial fibrillation (AF) is a common heart rhythm problem, and its occurrence is increasing. Many patients with persistent AF do not respond well to ablation treatments or are not suitable for them due to age, other health issues, or previous unsuccessful procedures. Since controlling heart rhythm does not improve survival compared to rate control, some patients undergo AV node ablation and pacemaker implantation to manage symptoms. This study focuses on comparing a new pacing method called HIS bundle pacing to the standard right ventricular pacing in patients with AF who show signs of heart failure. Participants will be randomly assigned to receive either right ventricular (RV) pacing or HIS bundle pacing (HBP). All will have a pacemaker implanted with a lead in the right ventricle, but only those in the HBP group will have an additional lead on the HIS bundle to stimulate the heart more naturally. AV node ablation will be performed either during the same procedure or within 4-6 weeks. The study uses a double-blind design, with follow-up evaluations at baseline, 4 weeks, 6 months, and 12 months, after which participants and assessors are unblinded. During the year-long study, participants will be monitored for improvements in walking ability, heart function through echocardiograms, heart failure hospitalizations, and pacemaker performance. Activity will be tracked using a Fitbit smartwatch to measure daily steps and walking distance. Safety will be assessed by monitoring for infections, lead problems, and the need for additional procedures. The trial aims to determine if HIS bundle pacing offers advantages over traditional RV pacing for these patients.
CONDITIONS
Brief Title
Ablate and Pace HIS Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 or above
- Symptomatic atrial fibrillation, New York Heart Association (NYHA) class II-IV
- Willing to consent for the study
- Atrial fibrillation of any type, not suitable for rhythm control strategy
- Referred for AV node ablation with either impaired left ventricular function (ejection fraction below 50%) or elevated NT-ProBNP levels above 365 ng/L
You will not qualify if you...
- Already have a pacemaker implanted
- Severe left ventricular systolic dysfunction where biventricular pacing is preferred
- Female in childbearing period
- Lack capacity to consent
- Other serious medical condition with life expectancy less than 1 year
- Younger than 18 years
- Unwilling to consent for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants undergo pacemaker implantation with leads positioned in the right ventricle and, if assigned, the distal HIS bundle. Participants also receive AV node ablation either at the same setting or 4-6 weeks later depending on clinical indication and operator preference.
1 implantation and ablation visit
Duration - 12 months
Participants are monitored with endpoint assessments including walking distance, heart function, and pacing parameters at baseline, 4 weeks, 6 months, and 12 months after treatment to evaluate safety and efficacy.
4 visits (baseline, 4 weeks, 6 months, 12 months)
Trial Site Locations
Total: 1 location
1
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE1 5WW
Actively Recruiting
Research Team
M
Mokhtar Ibrahim, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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