Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Spain / NCT06917066
Recruiting Observational

MYLEAD Spanish Prospective Registry

NCT06917066 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Clínico Universitario de Valladolid
Phase
Observational
Started
2024-10-23
Last updated
2025-04-08

Condition(s) studied

Severe Aortic Valve Stenosis

Investigational drug(s) / intervention(s)

TAVR

TAVR: TAVR procedure using Myval Transcatheter Heart Valve

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Presence of rhythm disorders — 30 days
    Presence of any of the following conduction defects detected in 12-lead ECG: 1. Atrial Fibrillation 2. Pacemarker 3. Left bundle branch block 4. Right bundle branch block 6\) 1st degree AVB 7) Other conduction disturbances

Trial sites (1)

FacilityCityRegionStatus
Hospital Clínico Universitario de Valladolid Valladolid Valladolid Recruiting

More Hospital Clínico Universitario de Valladolid trials in Spain

Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbidity, Mortality, Treatment and Outcome Analysis Recruiting
"KETOMED: Ketonemia and Risk of Emergence Delirium in Children Undergoing General Anesthesia - A Multicenter Observational Study" Active, not recruiting

Other trials for the same condition

Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation Recruiting
Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study) Recruiting
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06917066 on ClinicalTrials.gov ↗ ← All trials in Spain