Severe Aortic Stenosis
Conditions
Brief summary
The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures.
Interventions
DEVICETAVI
Patients with severe symptomatic AS undergoing Transcatheter aortic valve implantation (TAVI)
Sponsors
Opsens, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
Investigation participant number only
Intervention model description
A prospective, non-randomized, single-arm, multicenter, clinical performance pivotal clinical investigation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is at least 18 years old 2. Subject has a severe symptomatic AS undergoing a TAVI procedure 3. Subject with a THV for which rapid pacing is considered necessary during valve implantation 4. Subject agrees to participate in the study and is able to sign the informed consent form
Exclusion criteria
1. Failure to provide signed informed consent 2. Extremely horizontal aorta (aortic root angle ≥70°) 3. Extreme tortuosity at the level of the iliofemoral arteries, thoracic or abdominal aorta 4. Inability to receive full anticoagulation during the TAVI procedure 5. Prohibitive surgical risk precluding (according to the Heart Team) conversion to open heart surgery in case of a life-threatening complication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with effective rapid pacing run | during surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of major complications (safety) | during surgery | 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). |
| Percentage of patients with hemodynamic assessment without additional manipulation (pressure efficacy) | during surgery | 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. |
| Percentage of patient with valve advancement to intended position (mechanical efficacy) | during surgery | Effective advancement of the THV delivery system over the SavvyWireTM allowing a precise positioning of the valve to the intended deployment position. |
Countries
Spain
Outcome results
None listed