Conduction System Stimulation to Avoid Left Ventricle Dysfunction

NCT06026683 | Completed FDA Device

• 1 other identifier: STAY trial
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Delta-LVEF at 6 months

  Change in LVEF in each group at 6 months vs baseline LVEF

  6 months

Secondary Outcomes (7)

• Delta-LVEDD at 6 months

  6 months

• Delta-MLWHFQ (Minnesota score) at 6 months

  6 months

• Delta-New York Heart Association (NYHA) class at 6 months

  6 months

• Delta-NTProBNP at 6 months

  6 months

• Readmissions due to heart failure

  6 months

Study Arms (2)

CSP (Conduction system pacing)

ACTIVE COMPARATOR

Patients with pacemaker implanted with conduction system pacing.

Device: Pacemaker implant

RVAP (Right ventricular apical pacing)

ACTIVE COMPARATOR

Patients with pacemaker implanted with right ventricular apical pacing.

Device: Pacemaker implant

Interventions

Pacemaker implant DEVICE

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

CSP (Conduction system pacing); RVAP (Right ventricular apical pacing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years or more
• Preserved or mild deteriorated LVEF (Simpson \>40%) assessed by a recent (\<1 month before implantation) transthoracic echocardiography.
• Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (\>50%).
• Live expectancy of more than 6 months and capability to understand the protocol, signing the informed consent form and accomplish the follow-up.

You may not qualify if:

• Indication for implantable cardioverter defibrillator device.
• Patients with previous LVD and a recovered LVEF
• History of myocardial infarction/revascularization or cardiac surgery within 6 months before randomization
• Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

Related Publications (1)

• Gonzalez-Matos CE, Rodriguez-Queralto O, Zaraket F, Jimenez J, Casteigt B, Valles E. Conduction System Stimulation to Avoid Left Ventricle Dysfunction. Circ Arrhythm Electrophysiol. 2024 Feb;17(2):e012473. doi: 10.1161/CIRCEP.123.012473. Epub 2024 Jan 29.

  PMID: 38284238 DERIVED

MeSH Terms

Conditions

Atrioventricular Block; Neoplasm Metastasis; Heart Failure

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms

Study Officials

• Ermengol Vallès, PhD

  Parc de Salut Mar

  STUDY DIRECTOR

• Carlos González, M.D.

  Parc de Salut Mar. Universitat Autónoma de Barcelona.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study is blinded for the patient and for the echocardiographers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

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

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 7, 2023
• Study Start: September 30, 2019
• Primary Completion: October 2, 2023
• Study Completion: November 30, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)