Back to resultsSAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI) (SAFE-TAVI)
Primary Purpose
Severe Aortic Stenosis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
TAVI
Sponsored by
About this trial
This is an interventional other trial for Severe Aortic Stenosis
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitari Germans Trias i Pujol
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitari Vall d'Hebron
- Hospital Clínic de Barcelona
- Hospital Universitario Central de Asturias
- Hospital Álvaro Cunqueiro
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with severe symptomatic AS undergoing TAVI
Arm Description
Patients with severe symptomatic AS undergoing a TAVI procedure with a THV for which rapid pacing is considered necessary during valve implantation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05492383
Brief Title
SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)
Acronym
SAFE-TAVI
Official Title
SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
March 3, 2023 (Actual)
Study Completion Date
March 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Opsens, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Aortic Stenosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective, non-randomized, single-arm, multicenter, clinical performance pivotal clinical investigation.
Masking
None (Open Label)
Masking Description
Investigation participant number only
Allocation
N/A
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with severe symptomatic AS undergoing TAVI
Arm Type
Experimental
Arm Description
Patients with severe symptomatic AS undergoing a TAVI procedure with a THV for which rapid pacing is considered necessary during valve implantation
Intervention Type
Device
Intervention Name(s)
TAVI
Intervention Description
Patients with severe symptomatic AS undergoing Transcatheter aortic valve implantation (TAVI)
Primary Outcome Measure Information:
Title
Percentage of patients with effective rapid pacing run
Description
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 Outcome Measure Information:
Title
Presence of major complications (safety)
Description
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
Title
Percentage of patients with hemodynamic assessment without additional manipulation (pressure efficacy)
Description
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
Title
Percentage of patient with valve advancement to intended position (mechanical efficacy)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Rodés-Cabau, Dr
Organizational Affiliation
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36312
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)
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