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Completed

NCT Number: NCT06026683

Conduction System Stimulation to Avoid Left Ventricle Dysfunction

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.

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Key information

Conditions

Atrioventricular Block, Second and Third Degree Arrhythmias, Cardiac Atrioventricular Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Heart Failure Neoplasm Metastasis Neoplasms Neoplastic Processes Pacemaker-Induced Cardiomyopathy Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar

Barcelona, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pacemaker implant

Device

Implantation of pacemaker with conduction system pacing or right ventricular apical pacing

Primary outcomes

  1. Delta-LVEF at 6 months

    Time frame: 6 months

    Change in LVEF in each group at 6 months vs baseline LVEF

Secondary outcomes

  1. Delta-LVEDD at 6 months

    Time frame: 6 months

    Change in Left ventricular end diastolic diameter (LVEDD) in each group at 6 months vs baseline LVEDD

  2. Delta-MLWHFQ (Minnesota score) at 6 months

    Time frame: 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)

  3. Delta-New York Heart Association (NYHA) class at 6 months

    Time frame: 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.

  4. Delta-NTProBNP at 6 months

    Time frame: 6 months

    Change in NTProBNP levels in each group at 6 months vs baseline NTProBNP levels

  5. Readmissions due to heart failure

    Time frame: 6 months

    Number of readmissions due to heart failure in each group during follow-up

  6. New onset Atrial fibrillation

    Time frame: 6 months

    Number of new-onset atrial fibrillation episodes in each group during follow-up

  7. Mortality

    Time frame: 6 months

    All-cause Mortality in each group during follow-up

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Acronym: STAY

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 7, 2023
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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