NCT06707662Recruiting
Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction
Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction. A Multicenter Randomized Trial From the STAY Investigators
Source: ClinicalTrials.gov · Last updated 11 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 19 Nov 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Parc de Salut Mar
- Diseases
- Heart failure
- NCT number
- NCT06707662
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Jan 2025 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of myocardial infarction/revascularization or cardiac surgery within 6 months before randomization.
Other illness
- Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.
Lab values
- Patients with indication for a CRT device, with LVEF \<40%.
- Patients with previous severe LVD (Simpson LVEF \<30%) and a recovered LVEF.
Other
- Patients with indication for implantable cardioverter defibrillator device.
Who the study is looking for
- Age of 18 years or more.
- Preserved or mild deteriorated LVEF (Simpson \>40%) assessed by a recent (\<1 month before implantation) transthoracic echocardiography.
- Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (\>80%).
- Life expectancy of more than 12 months and capability to understand the protocol, signing informed consent form, and complying with follow-up.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital del Mar - IMIM Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.