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

Not Applicable

Completed

• Conditions: Severe Aortic Stenosis
• Interventions: Device: TAVI

• Registration Number: NCT05492383
• Lead Sponsor: Opsens, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-08
• Study Start: 2022-10-25
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with severe symptomatic AS undergoing TAVI	TAVI	Patients with severe symptomatic AS undergoing a TAVI procedure with a THV for which rapid pacing is considered necessary during valve implantation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).

Trial Locations

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

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain