Conduction System Stimulation to Avoid Left Ventricle Dysfunction

Heart Failure Clinical Trial

— STAY  

Official title:

Conduction System Stimulation to Avoid Left Ventricle Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06026683
• Other study ID #: STAY trial
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2024
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 30, 2023
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Age of 18 years or more

2. Preserved or mild deteriorated LVEF (Simpson >40%) assessed by a recent (<1 month before implantation) transthoracic echocardiography.

3. Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (>50%).

4. 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:

1. Indication for implantable cardioverter defibrillator device.

2. Patients with previous LVD and a recovered LVEF

3. History of myocardial infarction/revascularization or cardiac surgery within 6 months before randomization

4. Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.

Related Conditions & MeSH terms

• Atrioventricular Block
• Cardiomyopathies
• Heart Failure

Intervention

Device:
• Pacemaker implant
Implantation of pacemaker with conduction system pacing or right ventricular apical pacing

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta-LVEF at 6 months	Change in LVEF in each group at 6 months vs baseline LVEF	6 months
Secondary	Delta-LVEDD at 6 months	Change in Left ventricular end diastolic diameter (LVEDD) in each group at 6 months vs baseline LVEDD	6 months
Secondary	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
Secondary	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
Secondary	Delta-NTProBNP at 6 months	Change in NTProBNP levels in each group at 6 months vs baseline NTProBNP levels	6 months
Secondary	Readmissions due to heart failure	Number of readmissions due to heart failure in each group during follow-up	6 months
Secondary	New onset Atrial fibrillation	Number of new-onset atrial fibrillation episodes in each group during follow-up	6 months
Secondary	Mortality	All-cause Mortality in each group during follow-up	6 months