Registry for patients with severe aortic valve stenosis undergoing TAVR with Myval valve
Official title: Spanish Prospective Registry: MYval Induced Late and EArly Conduction Disturbances (MYLEAD)
Run by Hospital Clínico Universitario de Valladolid · NCT06917066 · Data updated 2026-11-12
This study is testing how often heart rhythm problems happen and if patients need a pacemaker after getting a new heart valve through TAVR using the Myval valve.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Hospital Clínico Universitario de Valladolid Academic / other |
| Locations | 1 site (Valladolid, Valladolid) |
| Status | Recruiting |
| Started | October 23, 2024 |
| Main results expected | December 2025 |
| Study ends | December 2026 |
| Registry record updated | April 8, 2025 |
| Trial ID | NCT06917066 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with severe aortic stenosis who are scheduled to undergo TAVR using the Myval valve.
✕Probably not a fit
Patients with a pre-existing permanent pacemaker or those unable to comply with follow-up assessments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicentre registry aimed at evaluating the incidence of conduction defects and the need for pacemaker implantation in patients with severe aortic valve stenosis who undergo transcatheter aortic valve replacement (TAVR) using the Myval Transcatheter Heart Valve. Patients will be monitored at various time points, including discharge, 30 days, and 1 year post-procedure, with assessments including electrocardiograms, echocardiograms, and computed tomography. Data will be collected in a dedicated REDCAP database for statistical analysis to identify factors influencing conduction defects.
Why it matters
Potential benefit: If successful, this study could improve patient outcomes by identifying risk factors for conduction defects and optimizing post-TAVR management.
How similar studies have gone: While similar studies have been conducted, this registry focuses specifically on the Myval valve, making it a novel approach in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain Recruiting
Study contacts
- Study coordinator: Ignacio J Amat-Santos, PhD
- Email: icicor@icicor.es
- Phone: +34 983420000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis
This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.
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Noninvasive ECG Monitoring to Support Early Discharge After TAVI for Conduction Disorders
A noninvasive ECG monitoring approach is tested to see if it safely allows patients with conduction issues after TAVI to go home earlier.
-
FAPI-PET imaging to see heart tissue changes after TAVI for aortic stenosis
Using FAPI-PET scans, doctors will see if heart scarring and function improve after TAVI in people with severe aortic stenosis compared with those treated with medication alone.
-
Comparing heart valve prostheses for treating aortic stenosis
This study is testing how well different types of heart valve replacements work for people with severe aortic stenosis, especially those with smaller heart openings.
-
Personalized antithrombotic therapy for patients after aortic valve replacement
This study is testing if a personalized blood-thinning treatment can help people who have had aortic valve replacement feel better and avoid complications compared to standard treatment.
-
Evaluating treatment options for aortic valve stenosis
This study is testing how different treatments for aortic valve stenosis, like surgery and other options, affect patients' quality of life and survival.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.