Actively Recruiting
MYLEAD Spanish Prospective Registry
Led by Hospital Clínico Universitario de Valladolid · Updated on 2025-04-08
500
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
Sponsors
H
Hospital Clínico Universitario de Valladolid
Lead Sponsor
M
Meril Life Sciences Pvt. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Investigator-initiated, prospective, multicentre registry, whose objectives are: 1/ to evaluate the incidence of conduction defects and the need of pacemaker implantation post-procedure, at discharge, at 30 days and at 1 year post Myval transcatheter heart valve deployment, and 2/ To evaluate the factors determining in-hospital and late (at 30 days and 1 year) conduction defects post Myval transcatheter heart valve. Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve that meet all inclusion criteria and any exclusion criteria will be able to participate in this study if they sign the informed consent. Electrocardiogram, echocardiogram and computed tomography will be performed to patients at different time points (Baseline, post-procedure, discharge, 30 days and 1 year post procedure) and their parameters will be added into a dedicated REDCAP database.
CONDITIONS
Official Title
MYLEAD Spanish Prospective Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (over 18 years of age)
- Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve.
You will not qualify if you...
- Patients with pre-existing permanent pacemaker.
- Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain, 47003
Actively Recruiting
Research Team
I
Ignacio J Amat-Santos, PhD
CONTACT
C
Carlos Baladrón, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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