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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01175-50 | Other Identifier | ID-RCB number, ANSM | |
| PHRC-17-0697 | Other Identifier | PHRC number, DGOS |
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| Name | Class |
|---|---|
| Siemens Healthineers, France | UNKNOWN |
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Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality. Transesophageal echocardiographic (TEE) is considered as the gold standard to assess the severity of PVR and guide the physician to perform corrective procedures during TAVI, but it requires general anesthesia (GA). With such approach (TEE+GA), the PARTNERII trial has demonstrated that very low rate of PVR (3,5%) can be achieved with current devices. Registries have demonstrated a strong trend for using a mini-invasive approach in which the procedure is performed under conscious sedation (CS) without TEE. However, several studies raised concerns on the safety of this mini-invasive approach concerning the PVR rate. Thus, the accurate and real-time assessment of the presence and severity of PVR is an unmet clinical need to optimize TAVI without TEE guidance. A recent study reported that a blood biomarker reflecting the Von Willebrand factor (VWF) activity, i.e. the closure time with adenosine diphosphate (CT-ADP), is a valuable non-invasive, highly reproducible, and easy to perform alternative to TEE for PVR evaluation.
The hypothesis is that the measurement of CT-ADP during TAVI performed without TEE guidance can improve both the detection of significant PVR and thus the procedural and clinical outcomes (primary objective).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-ADP group | Experimental | PVR assessment with the standard methods and with the CT-ADP that will be provided to the operator in real-time during TAVI. The decision to undertake corrective procedure will be left at the discretion of the operator and based on the results of the CT-ADP on top of the standard methods of PVR assessment. |
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| Control group | Other | PVR assessment with standard methods only (at discretion of the operator excluding CT-ADP and transesophageal echocardiography). CT-ADP will not be provided to the operator at the time of TAVI. The decision to undertake corrective procedure will be left at the discretion of the operator according to the results of the standard methods of PVR assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-ADP performed during TAVI procedure | Diagnostic Test | The CT-ADP will be performed in the catheterization laboratory and revealed to the operator. The decision to undertake corrective procedure will be based on CT-ADP on top of standard methods of PVR assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| composite 1-year event rate of | rate of All-cause death; rate of Paravalvular regurgitation ≥ moderate; rate of Rehospitalization; rate of Stroke; rate of Delayed valve re-intervention; rate of Mean transaortic gradient >20mmHg. | At 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death rate | All-cause death | At 30 days, at 1 year |
| PVR rate | PVR superior or egal to moderate | At 30 days, at 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Van Belle, MD,PhD | Contact | 03 20 44 50 15 | +33 | eric.vanbelle2@chru-lille.fr |
| Flavien Vincent, MD, PhD | Contact | 03 20 44 59 62 (31588) | +33 | flavien.vincent@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Eric Vanbelle, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Estaing - Chu63 - Clermont Ferrand | Recruiting | Clermont-Ferrand | France | |||
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Multicenter open-label randomized controlled clinical trial
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| No CT-ADP performed during TAVI procedure | Other | PVR assessment with the standard methods only (TTE and/or angiography and/or hemodynamics but excluding TEE and CT-ADP). The decision to undertake corrective procedure will be left at the discretion of the operator. |
|
| Rehospitalization for heart failure rate | Rehospitalization for heart failure | At 30 days, at 1 year |
| Delayed valve re-intervention rate | Delayed valve re-intervention | At 1 year |
| Delayed valve re-intervention rate | Delayed valve re-intervention | At 30 days, at 1 year |
| Mean transaortic gradient >20mmHg rate | Mean transaortic gradient >20mmHg | At 30 days |
| composite event rate | All-cause death; PVR superior or egal to moderate; Rehospitalization for heart failure; All stroke (transient or definite); Delayed valve re-intervention; Mean transaortic gradient >20mmHg | At 30 days |
| composite event rate of the following individual safety endpoints | Aortic injury; Coronary artery occlusion; Tamponade; All stroke (transient or definite) | at 24hours |
| Aortic injury rate | Aortic injury | at 24hours |
| Coronary artery occlusion rate | Coronary artery occlusion | at 24hours |
| Tamponade rate | Tamponade | at 24hours |
| All stroke (transient or definite) rate | All stroke (transient or definite) | at 24hours |
| Institut Coeur-Poumon, CHU |
| Recruiting |
| Lille |
| 59037 |
| France |
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| Chu Montpellier | Not yet recruiting | Montpellier | France |
| CHU de Nimes | Not yet recruiting | Nîmes | France |
| Hu Pitie Salpetriere Aphp - Paris 13 | Not yet recruiting | Paris | France |
| Hopital Haut-Leveque - Chu - Pessac | Recruiting | Pessac | 33604 | France |
| Chru Rennes Site Pontchaillou | Not yet recruiting | Rennes | France |
| Hopital Civil / Nouvel Hopital Civil - Strasbourg | Not yet recruiting | Strasbourg | France |
| CHU de Toulouse | Recruiting | Toulouse | France |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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