Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction

Recruiting · NCT06707662 · Interventional (participants receive a specific treatment) · Lead sponsor: Parc de Salut Mar

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Interventions studied

Pacemaker and defibrillator

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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.

Exclusion criteria

Patients with indication for implantable cardioverter defibrillator device.
Patients with indication for a CRT device, with LVEF \<40%.
Patients with previous severe LVD (Simpson LVEF \<30%) and a recovered LVEF.
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.

Where it is running

1 location listed.

Hospital del Mar - IMIM - Barcelona, Spain

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →