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| ID | Type | Description | Link |
|---|---|---|---|
| PI23/00310 | Other Grant/Funding Number | Instituto de Salud Carlos III |
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| Name | Class |
|---|---|
| Hospital Universitari de Bellvitge | OTHER |
| Hospital Universitario La Paz | OTHER |
| Hospital Vall d'Hebron | OTHER |
| Hospital Universitario Ramon y Cajal |
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The management of patients with conduction disturbances (CDs) after transcatheter aortic valve implantation (TAVI) is unclear, especially in those with de novo electrocardiographic CDs (ECG-CDs) such as left bundle branch block.
In this study, the investigators will evaluate the incidence of retrogradation of infra-Hisian CDs in patients with de novo ECG-CDs and positive electrophysiological study (EPS) 3-7 days following TAVI. In addition, the investigators will evaluate the need for cardiac pacing and the incidence of clinical events in patients with negative EPS performed 3-7 days following TAVI.
In this multicenter, longitudinal, prospective study, patients with clinical indication of EP study due to new-onset ECG-CDs after TAVI will be included. A permanent pacemaker will be implanted in patients with positive EPS and a second EPS will be performed in 30-45 days. Additionally, these patients will undergo 4-week continuous monitoring using the ePatch (Philips) long-term Holter recorder, to identify episodes of paroxysmal complete atrioventricular block. Patients with negative EP study will undergo clinical follow-up and continuous monitoring for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive initial (3-7 days following TAVI) electrophysiological study (EP+) | Experimental | Permanent pacemaker implantation. Continuous ECG monitoring during 4 weeks. Second EP study 30-45 days after TAVI. |
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| Negative initial (3-7 days following TAVI) electrophysiological study (EP-) | Other | Continuous ECG monitoring during 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrophysiological study (EP study) | Diagnostic Test | Electrophysiological study: A second EP study 30-45 days after TAVI will be performed in the group of patients with positive EP study 3-7 days after TAVI. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of retrogradation | 1. Patients with positive EP: Evaluate the incidence of retrogradation of infra-Hisian conduction disturbance at 30-45 days following TAVI. | 30 days |
| Need for cardiac pacing (incidence of advanced atrioventricular block) | 2. Patients with negative EP: Evaluate the rate of patients in need for cardiac pacing (incidence of clinical events related to advanced atrioventricular block). | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillem Muntané Carol, MD, PhD | Contact | +342607500 | 7539 | gmuntanec@bellvitgehospital.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08097 | Spain |
Study procotol and ICF will be shared trough PI request during the duration of the study
During the duration of the study
Request to the PI
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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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| OTHER |
| Hospital Universitario A Coruna Spain | UNKNOWN |
| Hospital Clinico Universitario de Santiago | OTHER |
| Hospital Universitario Central de Asturias | OTHER |
| Hospital Universitario Marqués de Valdecilla | OTHER |
| Hospital Clínico Universitario de Valladolid | OTHER |
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| ePatch (extended Holter Monitoring) | Diagnostic Test | Continuous cardiac rhythm monitoring using the ePatch (Philips) will be performed during 4 weeks after TAVI |
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| D014694 |
| Ventricular Outflow Obstruction |