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The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with severe symptomatic AS undergoing TAVI | Experimental | Patients with severe symptomatic AS undergoing a TAVI procedure with a THV for which rapid pacing is considered necessary during valve implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVI | Device | Patients with severe symptomatic AS undergoing Transcatheter aortic valve implantation (TAVI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with effective rapid pacing run | Effective rapid pacing will be defined as an adequate ventricular pacing capture by the SavvyWireTM leading to a reduction of systolic aortic pressure value <60 mmHg. | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of major complications (safety) | Presence of major complications related to the SAVVY guidewire including guidewire kink hindering or preventing the advancement of the transcatheter valve system, left ventricular perforation and pacing capture translating into major clinical consequences (transcatheter valve malpositioning or embolization). | during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josep Rodés-Cabau, Dr | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol | Badalona | 08916 | Spain | |||
| Hospital de la Santa Creu i Sant Pau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37902144 | Derived | Regueiro A, Alperi A, Vilalta V, Asmarats L, Baz JA, Nombela-Franco L, Calabuig A, Munoz-Garcia A, Sabate M, Moris C, Picard-Deland M, Pelletier-Beaumont E, Rodes-Cabau J. Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire: SAFE-TAVI Trial. JACC Cardiovasc Interv. 2023 Dec 25;16(24):3016-3023. doi: 10.1016/j.jcin.2023.10.035. Epub 2023 Oct 23. |
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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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A prospective, non-randomized, single-arm, multicenter, clinical performance pivotal clinical investigation.
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Investigation participant number only
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| Percentage of patients with hemodynamic assessment without additional manipulation (pressure efficacy) | Ventricular pressure recording with the SavvyWireTM, allowing gradient calculation and display by the OptoMonitor 3, without the need of additional device exchanges through the aortic valve after valve implantation. | during surgery |
| Percentage of patient with valve advancement to intended position (mechanical efficacy) | Effective advancement of the THV delivery system over the SavvyWireTM allowing a precise positioning of the valve to the intended deployment position. | during surgery |
| Barcelona |
| 08025 |
| Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Álvaro Cunqueiro | Vigo | 36312 | Spain |
| D014694 |
| Ventricular Outflow Obstruction |