The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures (SAVVY)

January 14, 2022 updated by: Josep Rodes-Cabau, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • IUCPQ
    • Quebec
      • Montréal, Quebec, Canada, H1T 1C8
        • ICM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Guidewire
The SAVVY guidewire will be used in all TAVR procedures of patients included in the study
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Periprocedural
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
Periprocedural
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.
Periprocedural
Number of valve embolization
Time Frame: Periprocedural
Pacing capture failure translating into valve embolization
Periprocedural
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.
Periprocedural
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).
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Institut de Cardiologie de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 8, 2021

Primary Completion (ACTUAL)

December 28, 2021

Study Completion (ACTUAL)

December 28, 2021

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (ACTUAL)

October 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRT-2015-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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