Conduction System Stimulation to Avoid Left Ventricle Dysfunction.
Carlos E González-Matos, Oriol Rodríguez-Queralto, Fátima Záraket...
https://pubmed.ncbi.nlm.nih.gov/38284238Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06707662
Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction A Multicenter Randomized Trial From the STAY Investigators
Led by Parc de Salut Mar · Updated on 2025-02-11
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of different pacing methods on heart function in patients who need a pacemaker due to a high degree atrioventricular block (AVB). The study focuses on comparing conventional right ventricular apical pacing (RVAP) with conduction system pacing (CSP), specifically left bundle branch pacing (LBBP) and left septal pacing (LVSP), to see which method better preserves the left ventricle ejection fraction (LVEF) and reduces heart failure admissions. This multicenter randomized trial aims to clarify whether LVSP and LBBP are superior to RVAP in patients with preserved or mildly reduced heart function.
CONDITIONS
Brief Title
Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age of 18 years or more
- Preserved or mildly deteriorated left ventricle ejection fraction (LVEF) greater than 40% by recent echocardiography
- Indication for pacemaker implantation due to high degree atrioventricular block with an anticipated ventricular pacing burden over 80%
- Life expectancy greater than 12 months and ability to understand the study, sign informed consent, and comply with follow-up
You will not qualify if you...
- Need for an implantable cardioverter defibrillator device
- Need for a cardiac resynchronization therapy device with LVEF less than 40%
- Previous severe left ventricle dysfunction with LVEF less than 30% even if recovered
- History of heart attack, 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
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Day of implantation
Participants undergo pacemaker implantation with either a right ventricle apical lead or a left bundle branch area lead (left bundle branch pacing or left septal pacing) based on randomization.
1 implantation visit (in-person)
Monitoring
Duration - 12 months
Participants are monitored for ventricular function and clinical outcomes following pacemaker implantation.
Periodic follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Hospital del Mar - IMIM
Barcelona, Spain, 08003
Actively Recruiting
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Research Team
E
Ermengol Valles, PhD
J
Jesus Jimenez, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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