Status:
COMPLETED
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
Lead Sponsor:
Parc de Salut Mar
Conditions:
Atrioventricular Block, Second and Third Degree
Pacemaker-Induced Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 pr...
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06026683
Start Date
September 30 2019
End Date
November 30 2023
Last Update
April 3 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital del Mar
Barcelona, Spain, 08003