Conduction System Stimulation to Avoid Left Ventricle Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2023-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Atrioventricular Block, Second and Third Degree Pacemaker-Induced Cardiomyopathy Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized into 2 groups according to pacing site: CSP vs RVAP.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The study is blinded for the patient and for the echocardiographers.

Study Groups

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CSP (Conduction system pacing)

Patients with pacemaker implanted with conduction system pacing.

Group Type ACTIVE_COMPARATOR

Pacemaker implant

Intervention Type DEVICE

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

RVAP (Right ventricular apical pacing)

Patients with pacemaker implanted with right ventricular apical pacing.

Group Type ACTIVE_COMPARATOR

Pacemaker implant

Intervention Type DEVICE

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

Interventions

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Pacemaker implant

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No