SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)

Study Overview
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Brief Summary
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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.

Official Title
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SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)

Conditions
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Severe Aortic Stenosis

Intervention / Treatment
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* Device: TAVI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years old Subject has a severe symptomatic AS undergoing a TAVI procedure Subject with a THV for which rapid pacing is considered necessary during valve implantation Subject agrees to participate in the study and is able to sign the informed consent form Exclusion Criteria: Failure to provide signed informed consent Extremely horizontal aorta (aortic root angle ≥70°) Extreme tortuosity at the level of the iliofemoral arteries, thoracic or abdominal aorta Inability to receive full anticoagulation during the TAVI procedure Prohibitive surgical risk precluding (according to the Heart Team) conversion to open heart surgery in case of a life-threatening complication.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, non-randomized, single-arm, multicenter, clinical performance pivotal clinical investigation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with severe symptomatic AS undergoing TAVI<br>Patients with severe symptomatic AS undergoing a TAVI procedure with a THV for which rapid pacing is considered necessary during valve implantation | Device: TAVI<br>* Patients with severe symptomatic AS undergoing Transcatheter aortic valve implantation (TAVI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |