High Intensity His Bundle Pacing for Heart Failure Patients
High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study
This study is testing if a special heart pacing technique can help people with heart failure feel better and improve their heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Miulli General Hospital Academic / other |
| Locations | 1 site (Acquaviva delle Fonti, Bari) |
| Trial ID | NCT05491655 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of high intensity His bundle pacing in heart failure patients who have a narrow QRS duration. It aims to determine if this pacing technique can improve hemodynamic function and overall heart performance in patients with dilated or ischemic cardiomyopathy and an ejection fraction of less than 50%. The study will involve implanting a CRT defibrillator with a lead positioned on the His bundle to achieve direct capture, and will include a one-month run-in period to stabilize pacing output. Participants will be monitored for improvements in heart function and clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with heart failure, a ventricular ejection fraction of less than 50%, and a narrow QRS duration of 110 ms or less.
Not a fit: Patients with other serious medical conditions, those who are pregnant, or those who have had previous aortic valve surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for heart failure patients with narrow QRS, potentially improving their heart function and reducing hospitalizations.
How similar studies have performed: While cardiac resynchronization therapy has been successful in certain heart failure populations, the specific application of high intensity His bundle pacing in patients with narrow QRS is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 or above * Ventricular Ejection Fraction (EF) \< 50%; BNP needs to be ≥250ng/L or N Terminal-pro BNP≥600ng/L for patients with EF 36-50% and they should have an ICD indication * New York Heart Association (NYHA) class I-IV * Narrow QRS duration (≤110ms) on 12 lead ECG Exclusion Criteria: * Other serious medical condition with life expectancy of less than 1 year * Lack of capacity to consent * Pregnancy * Previous aortic valve surgery
Where this trial is running
Acquaviva delle Fonti, Bari
- Miulli General Hospital — Acquaviva delle Fonti, Bari, Italy (Recruiting)
Study contacts
- Study coordinator: Grigorios Katsouras, MD, MSc
- Email: g.katsouras@miulli.it
- Phone: 0803054219
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.