The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures

Not Applicable

Completed

• Conditions: Transcatheter Aortic Valve Replacement; Aortic Valve Disease; Aortic Valve Stenosis; Hemodynamic Measurement
• Interventions: Device: SAVVY guidewire

• Registration Number: NCT05082337
• Lead Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Brief 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.

Study Timeline

• Study First Submitted: 2021-09-21
• Study Start: 2021-10-08
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-18
• Primary Completion: 2021-12-28
• Study Completion: 2021-12-28
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with severe symptomatic AS undergoing a TAVR procedure.

Exclusion Criteria

• Failure to provide signed informed consent.
• Extremely calcified aortic valve (Agatston score >3000 AU)
• Extremely horizontal aorta.
• Severe septal hypertrophy (interventricular septum >15 mm as measured by TTE).
• Extreme tortuosity at the level of the iliofemoral arteries, thoracic or abdominal aorta.
• Prohibitive surgical risk precluding (according to the Heart Team) conversion to open heart surgery in case of a life threatening complication.
• Young patients (<18 Years) and pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Guidewire	SAVVY guidewire	The SAVVY guidewire will be used in all TAVR procedures of patients included in the study

Primary Outcome Measures

Name	Time	Method
Presence of Major vascular complications	Periprocedural	Major vascular complications related to the SAVVY guidewire are defined as stroke, bleeding or left ventricular perforation
Number of transcatheter valve malpositioning	Periprocedural	Pacing capture failure translating into valve malpositioning. Valve malpositiong will be evaluated by a landing site to low or too high, leading to hemodynamically unfavorable results.
Presence of Major complications	Periprocedural	Presence of major complications related to the SAVVY guidewire including (i) guidewire kink hindering or preventing the advancement of the transcatheter valve system
Number of valve embolization	Periprocedural	Pacing capture failure translating into valve embolization
Number of effective rapid pacing run	Periprocedural	Effective rapid pacing will be defined as an adequate ventricular pacing capture for a minimum of 10 seconds, with no capture loss, and leading to a reduction of aortic pressure of at least 50%, with/or a systolic pressure value \<60 mmHg. Efficacy will be assessed by the physician.
Number of accurate ventricular pressure	Periprocedural	Accurate ventricular pressure will be defines as a pressure wire measurements similar (differences \<5 mmHg) to those obtained simultaneously with a pigtail catheter in the same cavity or vascular segment (differences \<5 mmHg in SBP, differences \<5 mmHg in LVEDP).

Trial Locations

Locations (2)

IUCPQ; 🇨🇦 Quebec, Canada

ICM; 🇨🇦 Montréal, Quebec, Canada