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

Severe Aortic Stenosis Clinical Trial

— SAFE-TAVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05492383
• Other study ID #: PRT-2015-32
• Status: Completed
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: March 3, 2023

Study information

• Verified date: April 2023
• Source: Opsens, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Severe Aortic Stenosis

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Álvaro Cunqueiro	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Opsens, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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