Evaluating safety and outcomes of different pacing methods for heart conditions
Registry of His Bundle, Bachmann Bundle and Left Bundle Branch Area Pacing for Various Pacing Indications
This study is testing different pacing methods for heart conditions to see if they are safer and more effective than the traditional approach.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 5 Years to 85 Years |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT04749836 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and clinical outcomes of various conduction system pacing methods, including His bundle pacing, left bundle branch area pacing, and Bachmann bundle pacing. By comparing these physiological pacing approaches to traditional right ventricular pacing, the study seeks to gather real-world data on their feasibility and effectiveness in treating conditions like AV block and atrial fibrillation. Participants will be monitored for implant success rates, procedural complications, and clinical outcomes over a minimum follow-up period of two years.
Who should consider this trial
Good fit: Ideal candidates include patients with Class I and II indications for permanent pacing, uncontrolled atrial fibrillation, or bundle branch block.
Not a fit: Patients who do not require permanent pacing or have contraindications for the pacing methods being studied may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pacing strategies that enhance heart function and patient quality of life.
How similar studies have performed: While there is limited data on the long-term performance of these physiological pacing methods, similar approaches have shown promise in improving patient outcomes in preliminary studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Class I and II indications for permanent pacing * Atrial fibrillation with uncontrolled ventricular rate for pace and ablate strategy * Bundle branch block correction for HF patients * Patients with prolonged PR interval and dromotropathy
Where this trial is running
Ljubljana
- University Medical Centre Ljubljana - Cardiology department — Ljubljana, Slovenia (Recruiting)
Study contacts
- Principal investigator: David Žižek, Assist. Prof. — University Medical Centre Ljubljana
- Study coordinator: David Žižek, Assist. Prof.
- Email: david.zizek@kclj.si
- Phone: +38615228534
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.