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| Name | Class |
|---|---|
| Meril Life Sciences Pvt. Ltd. | INDUSTRY |
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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.
Study Design: Investigator-initiated, prospective, multicentre registry. Study Phase: Phase IV.
Study Objectives:
Description of the study protocol:
Study duration:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Severe Aortic Valve Stenosis | All patients with Severe Aortic Valve Stenosis undergoing TAVR using Myval Transcatheter Heart Valve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVR | Procedure | TAVR procedure using Myval Transcatheter Heart Valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of rhythm disorders | Presence of any of the following conduction defects detected in 12-lead ECG:
6) 1st degree AVB 7) Other conduction disturbances | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of rhythm disorders | Presence of any of the following conduction defects detected in 12-lead ECG:
6) 1st degree AVB 7) Other conduction disturbances | Postprocedural, 7 days, 1 year |
| Duration of PR interval |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ignacio J Amat-Santos, PhD | Contact | +34 983420000 | 86571 | icicor@icicor.es |
| Carlos Baladrón, PhD | Contact | +34 983420000 | 86571 | icicor@icicor.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario de Valladolid | Recruiting | Valladolid | Valladolid | 47003 | Spain |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Duration of PR interval (ms) measured in ECG |
| Postprocedural, 7 days, 30 days, 1 year |
| Duration of QRS complex | Duration of QRS complex (ms) measured in ECG | Postprocedural, 7 days, 30 days, 1 year |
| D014694 |
| Ventricular Outflow Obstruction |