What is this study of HIS bundle pacing and right ventricular pacing trying to find out about atrial fibrillation?

This study is evaluating whether HIS bundle pacing is safer and more effective than right ventricular pacing in patients with atrial fibrillation who have heart failure symptoms and need AV node ablation. Researchers want to see if HIS bundle pacing improves heart function and quality of life. The study is sponsored by University Hospitals, Leicester.

Who may be eligible for this atrial fibrillation clinical trial?

Adults aged 18 to 100 with symptomatic atrial fibrillation classified as NYHA class II to IV may be eligible. Participants must be referred for AV node ablation and not suitable for rhythm control. Both men and women can join, but women in childbearing years are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this atrial fibrillation clinical trial?

Study-related care, including the pacemaker device, ablation procedure, and all trial visits, is provided at no cost. However, personal expenses such as travel to and from study visits may not be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 100Years

All Genders

ID06152406

Comparing Safety and Effectiveness of His Bundle Pacing Versus Right Ventricular Pacing in Adults with Symptomatic Atrial Fibrillation Undergoing AV Node Ablation and Heart Failure

Led by University Hospitals, Leicester · Updated on 2026-01-05

100

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 18Years - 100Years

All Genders

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

Research Team

Mokhtar Ibrahim, Dr

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