Conduction System Stimulation to Avoid Left Ventricle Dysfunction

Study Overview
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Brief Summary
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The aim of the study is to demonstrate that conduction system pacing (CSP) can preserve a normal ventricular function compared to right ventricular apical pacing (RVAP) in patients with pre-implant preserved left ventricular ejection fraction (LVEF) and a high burden of expected ventricular pacing due to atrioventricular conduction block (AV block). After informed consent signature, patients with high degree AV block and normal LVEF will be randomized to permanent pacemaker stimulation with CSP vs RVAP. All the patients have a complete evaluation before the procedure and at 3 and 6 months follow-up.

Detailed Description
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The STAY trial (Conduction System sTimulation to Avoid left ventricle dYsfunction) is a single-center, prospective, randomized, parallel, controlled study, comparing mid-term outcomes in a population undergoing pacemaker implantation due to a high degree atrio-ventricular block (AVB). The study was approved by the Hospital Ethics Committee, in accordance with the Declaration of Helsinki. All patients signed informed consent and were implanted between September 2019 until December 2022 in a 1:1 randomized fashion to conventional RVAP vs CSP (HBS or LBBS). Randomization was performed during the pre-procedural antibiotic infusion. All the patients have a complete evaluation before the procedure and at 3 and 6 months follow-up, including demographic and clinical characteristics, physical examination, twelve-lead ECG, Minnesota score (MLWHFQ), and blood test with NT-ProBNP determination. Patients also have a transthoracic echography before the procedure and at 6 months follow-up. At 6 months echocardiographic and clinical data will be compared.

Official Title
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Conduction System Stimulation to Avoid Left Ventricle Dysfunction

Conditions
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Atrioventricular Block, Second and Third Degree, Pacemaker-Induced Cardiomyopathy, Heart Failure

Intervention / Treatment
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* Device: Pacemaker implant


Participation Criteria
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Eligibility Criteria
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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 (>50%). Live expectancy of more than 6 months and capability to understand the protocol, signing the informed consent form and accomplish the follow-up. Exclusion criteria: Indication for implantable cardioverter defibrillator device. Patients with previous LVD 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized into 2 groups according to pacing site: CSP vs RVAP.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CSP (Conduction system pacing)<br>Patients with pacemaker implanted with conduction system pacing. | Device: Pacemaker implant<br>* Implantation of pacemaker with conduction system pacing or right ventricular apical pacing<br>|
| Active Comparator: RVAP (Right ventricular apical pacing)<br>Patients with pacemaker implanted with right ventricular apical pacing. | Device: Pacemaker implant<br>* Implantation of pacemaker with conduction system pacing or right ventricular apical pacing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delta-LVEF at 6 months | Change in LVEF in each group at 6 months vs baseline LVEF | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delta-LVEDD at 6 months | Change in Left ventricular end diastolic diameter (LVEDD) in each group at 6 months vs baseline LVEDD | 6 months | 
| Delta-MLWHFQ (Minnesota score) at 6 months | Change in MLWHFQ score in each group at 6 months vs baseline MLWHFQ score. The MLWHFQ score is obtained by using a questionnaire of 21 aspects. It depicts how heart failure affected the daily life of the patients during the last month previous to the questionnaire. Each question can be scored from 0 (No effect) to 5 (Very much effect) | 6 months | 
| Delta-New York Heart Association (NYHA) class at 6 months | Change in NYHA class in each group at 6 months vs baseline NYHA class. NYHA class places patients in one of four categories based on limitations of physical activity: I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. | 6 months | 
| Delta-NTProBNP at 6 months | Change in NTProBNP levels in each group at 6 months vs baseline NTProBNP levels | 6 months | 
| Readmissions due to heart failure | Number of readmissions due to heart failure in each group during follow-up | 6 months | 
| New onset Atrial fibrillation | Number of new-onset atrial fibrillation episodes in each group during follow-up | 6 months | 
| Mortality | All-cause Mortality in each group during follow-up | 6 months |