Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction
ConditionAV Block
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorParc de Salut Mar
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pacemaker and defibrillator
DevicePacemaker implantation, which can be a regular right ventricle apical lead or a LBBAP lead (LBBP or LVSP dependint on the criteria accomplished).
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Right Ventricle Apical PacingActive comparator 1 intervention
Group B: Left bundle branch pacingExperimental treatment 1 intervention
Group C: Left septal pacingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
LVEF evolution
Change in the value (%) of LVEF at 12 months compared to basal
Time frame
At 12 months after the pacemaker implantation2
Admission due to HF
Hospital admission due to episode of heart failure (new onset HF or worsening from baseline NYHA)
Time frame
From date of implantation until the date of first admission due to HF, whichever came first, assessed up to 12 monthsSecondary outcomes
1
LVEED evolution
Change in left ventricle end dyastolic diametre from the baseline, at 12 months from pacemaker implantation
Time frame
At 12 months after the pacemaker implantation2
Admission due to AF
Hospital admission due to atrial fibrillation (new onset or relapse) after the pacemaker implantation
Time frame
From date of implantation until the date of first admission due to AF, whichever came first, assessed up to 12 monthsOther outcomes
1
Change in ProBNP
Change in the value of pro-BNP at 12 months compared to baseline before pacemaker implantation
Time frame
At 12 months after the pacemaker implantation2
NYHA evolution
Change in the NYHA heart failure class at 12 months compared to baseline
Time frame
At 12 months after the pacemaker implantation3
MLWHFQ evolution
Change in the Minessota Living With Heart Failure Questionnare at 12 months compared to baseline (0-105 points, being 105 de worse situation)
Time frame
At 12 months after the pacemaker implantationSponsors and contacts
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Source ClinicalTrials.gov