Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06026683
Other study ID # STAY trial
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
Completed NCT04549181 - Problem-Solving for Rural Heart Failure Dyads N/A