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

Opsens, Inc.119 enrolled

Overview

The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

119

Conditions

Severe Aortic Stenosis

Interventions

TAVIDEVICE

Patients with severe symptomatic AS undergoing Transcatheter aortic valve implantation (TAVI)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Hospital Universitari Germans Trias i Pujol

Badalona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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