Actively Recruiting
Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction
Led by Parc de Salut Mar · Updated on 2025-02-11
150
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Right ventricular apical pacing (RVAP) can produce left ventricular dysfunction (LVD). Conduction system pacing (CSP) has been used successfully to reverse LVD in patients with left bundle branch block. A recent randomized controlled trial (RCT) has demonstrated that CSP, mostly performed with left bundle branch area pacing (LBBAP), can preserve normal ventricular function and heart failure admissions compared to RVAP in the setting of a high burden of ventricular pacing11 (Stay Trial). Criteria to assess the LBBAP distinguishes those cases in which the LBB is captured (LBBP) from those in which only the muscular septum surrounding the LBB is captured (LVSP). To date, data regarding LVSP to preserve left ventricle ejection fraction (LVEF) is scarce and limited to non-randomized studies.
CONDITIONS
Official Title
Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18 years or more
- Preserved or mildly deteriorated left ventricle ejection fraction (LVEF) above 40% measured within 1 month before implantation
- Indication for pacing due to high degree atrioventricular block with an expected ventricular pacing burden above 80%
- Life expectancy over 12 months and ability to understand the study, provide informed consent, and comply with follow-up
You will not qualify if you...
- Need for implantable cardioverter defibrillator device
- Need for cardiac resynchronization therapy device with LVEF below 40%
- Previous severe left ventricular dysfunction with LVEF below 30% even if recovered
- History of myocardial infarction, revascularization, or cardiac surgery within 6 months before randomization
- Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital del Mar - IMIM
Barcelona, Spain, 08003
Actively Recruiting
Research Team
E
Ermengol Valles, PhD
CONTACT
J
Jesus Jimenez, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here