Comparing His-bundle pacing and Right Ventricular Apical Pacing for Heart Failure
Official title: His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection
Run by Region Skane · NCT04529577 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if a new type of heart pacing called His-bundle pacing works better than the standard right ventricular apical pacing for people with heart failure and a specific heart block who need a pacemaker.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Region Skane Academic / other |
| Locations | 3 sites (Lund and 2 other locations) |
| Trial ID | NCT04529577 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with high-degree AV block and a left ventricular ejection fraction between 40% and 55%.
✕Probably not a fit
Patients with conditions such as hypertrophic cardiomyopathy, cardiac sarcoidosis, or those who have had a recent myocardial infarction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares the effectiveness of His-bundle pacing versus standard right ventricular apical pacing in patients with reduced ejection fraction and atrioventricular block requiring pacemaker therapy. It employs a randomized double-blinded crossover design, where patients receive both pacing modalities over a 6-month period, allowing for direct comparison of outcomes. The primary outcome measured is the change in left ventricular ejection fraction, while secondary outcomes include device safety and quality of life assessments. Patients are closely monitored, and both the patients and endpoint adjudicators remain blinded to the pacing modality during the study.
Why it matters
Potential benefit: If successful, this study could improve heart function and quality of life for patients with heart failure requiring pacing.
How similar studies have gone: Other studies have shown promising results with His-bundle pacing, indicating potential benefits over traditional pacing methods.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * AV block II or III with high expected pacing need * Left ventricular ejection fraction between 40% and 55% (inclusive) * Willing to participate and sign informed consent Exclusion Criteria: * Under 18 years old * Pregnant * Hypertrophic cardiomyopathy * Cardiac sarcoidosis * Cardiac amyloidosis * Previous myocardial infarction within last 3 months * Ventricular septum defect or other other left ventricular corrective surgery * Congenital heart disease surgically corrected * Atrial fibrillation with uncontrolled rate (if not planned for AV node ablation)
Where it's running
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Skane University Hospital
Lund, Sweden Recruiting -
Norrland University Hospital
Umeå, Sweden Recruiting -
Region Hallands Sjukhus Varberg
Varberg, Sweden Recruiting
Study contacts
- Principal investigator: Rasmus Borgquist, MD PhD — Lund University, Skane University Hospital, Arrhythmia Section, Lund, Sweden
- Study coordinator: Maiwand Farouq, MD, PhD
- Email: maiwand.farouq@skane.se
- Phone: + 46 40 336415
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
LY3971297 in heart failure: safety and tolerability in HF with preserved and reduced ejection fraction
This study tests how well LY3971297 is tolerated and what side effects occur in people with HFpEF or HFrEF.
-
Acetazolamide versus metolazone added to usual diuretics for acute decompensated heart failure
This trial will test whether adding acetazolamide or metolazone to standard diuretics works better and is safer for adults hospitalized with acute decompensated heart failure.
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Heart performance during steep head-down positioning for robotic pelvic surgery
This test looks at how heart function changes during steep head-down tilt in people having robotic pelvic surgery, including those with and without systolic heart failure.
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Paced heart rate acceleration for improving heart function
This study is testing if a special heart pacing treatment that mimics exercise can help people with systolic heart failure feel better and improve their heart function compared to a fake treatment.
-
Evaluating different approaches to cardiac pacing in patients
This study is testing different ways to place pacemakers in adults to see which methods work best and are safest for patients needing heart support.
-
Ablation and pacing for patients with atrial fibrillation
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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.