The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-08

Study Completion Date

2021-12-28

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Guidewire

The SAVVY guidewire will be used in all TAVR procedures of patients included in the study

Group Type EXPERIMENTAL

SAVVY guidewire

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No