Severe Aortic Valve StenosisMYLEADNCT06917066
MYLEAD Spanish Prospective Registry
An observational study of Severe Aortic Valve Stenosis, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Valve Stenosis
- What is being tested?
- TAVR
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 23 Oct 2024to Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with of Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve who meet all inclusion criteria and any exclusion criteria in 32 centers in Spain.
Who may be able to join
- Adult patients (over 18 years of age)
- Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve.
Who cannot join
- Patients with pre-existing permanent pacemaker.
- Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47003
Ignacio J. Amat-Santos, PhD, +34 983420000 ext. 86571, icicor@icicor.es
About this study
Official title: Spanish Prospective Registry: MYval Induced Late and EArly Conduction Disturbances (MYLEAD)
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.
Read the detailed description
Study Design: Investigator-initiated, prospective, multicentre registry. Study Phase: Phase IV.
Study Objectives:
- 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.
- To evaluate the factors determining in-hospital and late (at 30 days and 1 year) conduction defects post Myval transcatheter heart valve.
Description of the study protocol:
- Patients meeting the inclusion and exclusion criteria will be enrolled after taking informed consent. The baseline data and electrocardiogram (ECG), echocardiogram and computed tomography parameters will be added into a dedicated REDCAP database.
- TAVR will be performed as per the standard procedure using Myval Transcatheter Heart Valve.
- The ECG parameters post procedure, at discharge, at 30 days and at 1 year post-procedure will be noted using the REDCAP database.
- Based on these ECG parameters, analysis will be done to look for mean variations of PR and QRS segments, atrio-ventricular block, bundle branch block or need for pacemaker from baseline to post-procedure, at discharge, at 30 days and at 1 year post procedure.
- Echocardiogram parameters at 30 days (optional) and at 1 year post procedure will be noted using the REDCAP database.
- Statistical analysis will be done using IBM SPSS Statistics and R software.
Study duration:
- Inclusion stage: Patients will be recruited during the index procedure; if the patient meets all the inclusion criteria and any exclusion criteria and accepts to participate. ECG, echocardiogram and computed tomography will be done at baseline and the relevant information will be entered into the electronic database.
- In-hospital stage: Postprocedural and predischarge ECGs will be obtained and all the required clinical information will be gathered before discharge.
- Follow up stage: Clinical follow-up will be performed at 30 days and at 1 year post procedure, and the required ECG parameters will be obtained. At the 30-day follow-up, echocardiographic variables will be collected if the centers are available to perform echocardiograms or if an echocardiogram has been performed to the patients for other reasons within the determined period. In the 1-year follow-up, echocardiographic variables collected by clinical practice will be recorded.
- Conditions
- Severe Aortic Valve Stenosis
- Being tested
- TAVR
- Keywords
- Severe Aortic Valve Stenosis, TAVR, Myval Transcatheter Heart Valve
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVRProcedure or surgery
TAVR procedure using Myval Transcatheter Heart Valve
| Study group | Role | What they receive |
|---|---|---|
| Patients with Severe Aortic Valve Stenosis | All patients with Severe Aortic Valve Stenosis undergoing TAVR using Myval Transcatheter Heart Valve Receives: Procedure: TAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of rhythm disorders
Presence of any of the following conduction defects detected in 12-lead ECG:
- Atrial Fibrillation
- Pacemarker
- Left bundle branch block
- Right bundle branch block
- 1st degree AVB 7) Other conduction disturbances
Measured: 30 days
Secondary outcomes (3)
Presence of rhythm disorders
Presence of any of the following conduction defects detected in 12-lead ECG:
- Atrial Fibrillation
- Pacemarker
- Left bundle branch block
- Right bundle branch block
- 1st degree AVB 7) Other conduction disturbances
Measured: Postprocedural, 7 days, 1 year
Duration of PR interval
Duration of PR interval (ms) measured in ECG
Measured: Postprocedural, 7 days, 30 days, 1 year
Duration of QRS complex
Duration of QRS complex (ms) measured in ECG
Measured: Postprocedural, 7 days, 30 days, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start23 Oct 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hospital Clínico Universitario de Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Meril Life Sciences Pvt. Ltd.
- Responsible party
- Principal investigator, Ignacio J. Amat Santos, Hospital Clínico Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917066
- Sponsor's protocol ID
- PS-24-22-C
- Acronym
- MYLEAD
- Status last verified
- Apr 2025
- First submitted
- 13 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Prospective Registry: MYval Induced Late and EArly Conduction Disturbances (MYLEAD)
- ClinicalTrials.gov ID
- NCT06917066
- Acronym / sponsor ID
- MYLEAD / PS-24-22-C
- Conditions
- Severe Aortic Valve Stenosis
- Keywords
- Severe Aortic Valve Stenosis, TAVR, Myval Transcatheter Heart Valve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital Clínico Universitario de ValladolidUniversity, hospital or other
- Collaborators
- Meril Life Sciences Pvt. Ltd.
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design: Investigator-initiated, prospective, multicentre registry. Study Phase: Phase IV.
Study Objectives:
- 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.
- To evaluate the factors determining in-hospital and late (at 30 days and 1 year) conduction defects post Myval transcatheter heart valve.
Description of the study protocol:
- Patients meeting the inclusion and exclusion criteria will be enrolled after taking informed consent. The baseline data and electrocardiogram (ECG), echocardiogram and computed tomography parameters will be added into a dedicated REDCAP database.
- TAVR will be performed as per the standard procedure using Myval Transcatheter Heart Valve.
- The ECG parameters post procedure, at discharge, at 30 days and at 1 year post-procedure will be noted using the REDCAP database.
- Based on these ECG parameters, analysis will be done to look for mean variations of PR and QRS segments, atrio-ventricular block, bundle branch block or need for pacemaker from baseline to post-procedure, at discharge, at 30 days and at 1 year post procedure.
- Echocardiogram parameters at 30 days (optional) and at 1 year post procedure will be noted using the REDCAP database.
- Statistical analysis will be done using IBM SPSS Statistics and R software.
Study duration:
- Inclusion stage: Patients will be recruited during the index procedure; if the patient meets all the inclusion criteria and any exclusion criteria and accepts to participate. ECG, echocardiogram and computed tomography will be done at baseline and the relevant information will be entered into the electronic database.
- In-hospital stage: Postprocedural and predischarge ECGs will be obtained and all the required clinical information will be gathered before discharge.
- Follow up stage: Clinical follow-up will be performed at 30 days and at 1 year post procedure, and the required ECG parameters will be obtained. At the 30-day follow-up, echocardiographic variables will be collected if the centers are available to perform echocardiograms or if an echocardiogram has been performed to the patients for other reasons within the determined period. In the 1-year follow-up, echocardiographic variables collected by clinical practice will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Severe Aortic Valve Stenosis | – | Procedure: TAVRAll patients with Severe Aortic Valve Stenosis undergoing TAVR using Myval Transcatheter Heart Valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with of Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve who meet all inclusion criteria and any exclusion criteria in 32 centers in Spain.
Key inclusion criteria (2 listed)
- Adult patients (over 18 years of age)
- Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve.
Key exclusion criteria (2 listed)
- Patients with pre-existing permanent pacemaker.
- Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVRTAVR procedure using Myval Transcatheter Heart Valve | Procedure or surgery | Patients with Severe Aortic Valve Stenosis |
Primary outcome
Presence of rhythm disorders
Time frame: 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
3 secondary outcomes
Presence of rhythm disorders
Time frame: Postprocedural, 7 days, 1 year
Duration of PR interval
Time frame: Postprocedural, 7 days, 30 days, 1 year
Duration of QRS complex
Time frame: Postprocedural, 7 days, 30 days, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Aortic Valve Stenosis, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ignacio J Amat-Santos, PhD (+34 983420000 ext. 86571, icicor@icicor.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of rhythm disorders (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.