Comparing His-bundle pacing and Right Ventricular Apical Pacing for Heart Failure
His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 3 sites (Lund and 2 other locations) |
| Trial ID | NCT04529577 on ClinicalTrials.gov |
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.
Who should consider this trial
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%.
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.
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 performed: Other 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: * 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 this trial is running
Lund and 2 other locations
- 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
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.