Conduction System Stimulation to Avoid Left Ventricle Dysfunction

Not Applicable

Completed

• Conditions: Heart Failure; Atrioventricular Block, Second and Third Degree; Pacemaker-Induced Cardiomyopathy
• Interventions: Device: Pacemaker implant

• Registration Number: NCT06026683
• Lead Sponsor: Parc de Salut Mar

Brief 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.

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 Timeline

• Study Start: 2019-09-30
• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-08-30
• Study First Posted: 2023-09-07
• Primary Completion: 2023-10-02
• Study Completion: 2023-11-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RVAP (Right ventricular apical pacing)	Pacemaker implant	Patients with pacemaker implanted with right ventricular apical pacing.
CSP (Conduction system pacing)	Pacemaker implant	Patients with pacemaker implanted with conduction system pacing.

Primary Outcome Measures

Name	Time	Method
Delta-LVEF at 6 months	6 months	Change in LVEF in each group at 6 months vs baseline LVEF

Secondary Outcome Measures

Name	Time	Method
Delta-LVEDD at 6 months	6 months	Change in Left ventricular end diastolic diameter (LVEDD) in each group at 6 months vs baseline LVEDD
Delta-New York Heart Association (NYHA) class at 6 months	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.
Delta-NTProBNP at 6 months	6 months	Change in NTProBNP levels in each group at 6 months vs baseline NTProBNP levels
New onset Atrial fibrillation	6 months	Number of new-onset atrial fibrillation episodes in each group during follow-up
Delta-MLWHFQ (Minnesota score) at 6 months	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)
Readmissions due to heart failure	6 months	Number of readmissions due to heart failure in each group during follow-up
Mortality	6 months	All-cause Mortality in each group during follow-up

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain