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Completed

NCT Number: NCT05082337

The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures

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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Key information

Conditions

Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Hemodynamic Measurement Transcatheter Aortic Valve Replacement Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICM, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAVVY guidewire

Device

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

Primary outcomes

  1. Presence of Major complications

    Time frame: Periprocedural

    Presence of major complications related to the SAVVY guidewire including (i) guidewire kink hindering or preventing the advancement of the transcatheter valve system

  2. Presence of Major vascular complications

    Time frame: Periprocedural

    Major vascular complications related to the SAVVY guidewire are defined as stroke, bleeding or left ventricular perforation

  3. Number of transcatheter valve malpositioning

    Time frame: 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.

  4. Number of valve embolization

    Time frame: Periprocedural

    Pacing capture failure translating into valve embolization

  5. Number of effective rapid pacing run

    Time frame: 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.

  6. Number of accurate ventricular pressure

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Institut de Cardiologie de Montréal

Registry information

Official study title

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

Acronym: SAVVY

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 18, 2021
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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