An interventional study of TAVI in Severe Aortic Stenosis, sponsored by Opsens, Inc.. Completed at 6 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by Opsens, Inc. · Not applicable, Interventional, and Other
The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 119 is close to the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Opsens, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with severe symptomatic AS undergoing a TAVI procedure with a THV for which rapid pacing is considered necessary during valve implantation
Device: TAVI
Patients with severe symptomatic AS undergoing Transcatheter aortic valve implantation (TAVI)
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.
Time frame: during surgery
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).
Time frame: during surgery
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.
Time frame: 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.
Time frame: during surgery
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Opsens, Inc.