Spanish Prospective Registry: MYval Induced Late and EArly Conduction Disturbances (MYLEAD)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients (over 18 years of age)

• Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve.

Locations
Other Locations
Spain
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
Contact Information
Primary
Ignacio J Amat-Santos, PhD
icicor@icicor.es
+34 983420000
Backup
Carlos Baladrón, PhD
icicor@icicor.es
+34 983420000
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2026-12
Participants
Target number of participants: 500
Treatments
Patients with Severe Aortic Valve Stenosis
All patients with Severe Aortic Valve Stenosis undergoing TAVR using Myval Transcatheter Heart Valve
Related Therapeutic Areas
Sponsors
Collaborators: Meril Life Sciences Pvt. Ltd.
Leads: Hospital Clínico Universitario de Valladolid

This content was sourced from clinicaltrials.gov