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MYLEAD Spanish Prospective Registry

RECRUITINGSponsored by Hospital Clínico Universitario de Valladolid
Actively Recruiting
SponsorHospital Clínico Universitario de Valladolid
Started2024-10-23
Est. completion2025-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06917066

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Adult patients (over 18 years of age)
* Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve.

Exclusion Criteria:

* Patients with pre-existing permanent pacemaker.
* Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations.

Conditions2

Heart DiseaseSevere Aortic Valve Stenosis

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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