NCT05082337: SAVVY

The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures

Completed NA Last updated 18 January 2022

What this trial tests

NA trial testing SAVVY guidewire in Aortic Valve Disease in 20 participants. Completed in 28 December 2021.

Timeline

8 October 2021

Primary endpoint
28 December 2021

28 December 2021

Quick facts

Lead sponsor	Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	20
Start date	8 October 2021
Primary completion	28 December 2021
Estimated completion	28 December 2021
Sites	2 locations across Canada

Drugs / interventions tested

• SAVVY guidewire

Conditions studied

• Aortic Valve Disease — all drugs for Aortic Valve Disease →
• Transcatheter Aortic Valve Replacement — all drugs for Transcatheter Aortic Valve Replacement →
• Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
• Hemodynamic Measurement — all drugs for Hemodynamic Measurement →

Sponsor

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Who can join

18 and older, any sex, with Aortic Valve Disease or Transcatheter Aortic Valve Replacement. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

TAVR patients exhibiting post-procedural residual AR had higher mortality and hospitalization rates due to heart failure, with the extent of this association increasing proportionally to the severity of the regurgitation. Optimizing transcatheter valve performance by intra-procedural hemodynamic evaluation of AR and residual transvalvular gradient remains of high clinical importance.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Best Practices in Left Ventricular Pacing for Transcatheter Aortic Valve Replacement.
   Blusztein D, Raney A, Walsh J, Nazif T, et al · · 2023 · cited 9× · PMID 38046859 · DOI 10.1016/j.shj.2023.100213
2. A pressure wire for rapid pacing, valve implantation and continuous haemodynamic monitoring during transcatheter aortic valve implantation procedures.
   Rodés-Cabau J, Ibrahim R, De Larochellière R, Ben Ali W, et al · · 2022 · cited 8× · PMID 35588013 · DOI 10.4244/eij-d-22-00190
3. An evaluation of the SavvyWire as a support wire for TAVR procedures.
   Farjat-Pasos JI, Avvedimento M, Rodes-Cabau J. · · 2025 · cited 1× · PMID 40417940 · DOI 10.1080/14796678.2025.2509458
4. Evaluation of the OpSens OptoWire III and Novel TAVR Algorithm to Measure Pressure Gradient During TAVR.
   Généreux P, Kipperman RM, Placido Disla JS, Aldaia L, et al · · 2022 · cited 1× · PMID 39131936 · DOI 10.1016/j.jscai.2022.100309
5. Real-time Hemodynamic Monitoring During TAVR, Stepping Toward the Ideal TAVR Wire.
   Atkinson TM, Rihal C. · · 2022 · PMID 39131932 · DOI 10.1016/j.jscai.2022.100316