NCT05082337

The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures

The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures: A Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Continuous technological development and procedural refinements are important to further reduce TAVR peri-procedural complications, facilitate the minimalist strategy and improve clinical outcomes following TAVR. Residual aortic regurgitation (AR) has been one of the main drawbacks of TAVR. 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. Various actions could be undertaken to minimize AR and its consequences, either intraprocedural (balloon post-dilation, implantation of a second valve) or during follow-up (diuretic treatment, closest clinical follow-up or percutaneous leakage closure). Thus, an accurate diagnosis of the presence and severity of residual AR post-TAVR is key to implement the proper measures and optimize clinical outcomes. The use of cardiac imaging remains the gold standard for evaluating AR post-TAVR, limitations of contrast amount along with the subjectivity of AR evaluation by aortic angiography, and the challenges of echocardiography at the time of the TAVR procedure represent a significant drawback. Thus, alternative tools for evaluating the presence and severity of AR would be very helpful in this setting. Current data supports the implementation of hemodynamic measurements during TAVR procedures in order to improve the clinical decision-making process following valve implantation. However, these actions entail an inherent risk associated with the exchange of catheter-wires. The use of a support guidewire with pressure measurement capabilities would facilitate the hemodynamic evaluation of transcatheter valve performance in a safer and more rapid manner. The new SAVVY guidewire, with both dedicated pacing properties and allowing a continuous hemodynamic pressure monitoring during the procedure, is a unique system in the field and may represent an important step forward in the process of optimizing the TAVR procedure while facilitating procedural steps.

Conditions

• Aortic Valve Disease
• Transcatheter Aortic Valve Replacement
• Aortic Valve Stenosis
• Hemodynamic Measurement

Interventions

Type	Name	Description
DEVICE	SAVVY guidewire	The SAVVY guidewire will be used for rapid pacing runs, valve delivery and for left ventricular pressure measurements pre- and post-THV deployment

Timeline

• Start date: 2021-10-08
• Primary completion: 2021-12-28
• Completion: 2021-12-28
• First posted: 2021-10-18
• Last updated: 2022-01-18

Locations

2 sites across 1 country: Canada