Clinical trial NCT05082337: The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures
Official title: The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disease
Transcatheter Aortic Valve Replacement
Aortic Valve Stenosis
Hemodynamic Measurement
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
Collaborators: name: Institut de Cardiologie de Montréal
First posted: 2021-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient with severe symptomatic aortic stenosis with a clinical indication for TAVR according to the Heart Team criteria will be treated with an approved aortic valve (balloon-expandable or self-expandable aortic valve) and the SAVVY guidewire will be used for the rapid pacing runs and ventricular pressure measurements.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of Major complications
timeFrame: Periprocedural
measure: Presence of Major vascular complications
timeFrame: Periprocedural
measure: Number of transcatheter valve malpositioning
timeFrame: Periprocedural
measure: Number of valve embolization
timeFrame: Periprocedural
measure: Number of effective rapid pacing run
timeFrame: Periprocedural
measure: Number of accurate ventricular pressure
timeFrame: Periprocedural
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: ICM
state: Quebec
city: Quebec
country: Canada
facility: IUCPQ
Study officials:
References:
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