Conduction System Stimulation to Avoid Left Ventricle Dysfunction (STAY)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Pacemaker-Induced Cardiomyopathy; Atrioventricular Block, Second and Third Degree
• Intervention / Treatment: Device: Pacemaker implant

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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-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
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

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Investigators: Study Director: Ermengol Vallès, PhD, Parc de Salut Mar; Principal Investigator: Carlos González, M.D., Parc de Salut Mar. Universitat Autónoma de Barcelona.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): October 2, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Cardiomyopathies; Atrioventricular Block
• Other Study ID Numbers: STAY trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will only be available upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes