VALVOSOFT® Pivotal Study

August 19, 2024 updated by: Cardiawave SA

Prospective, Single-arm Pivotal Study for the Treatment of Subjects With Severe Symptomatic Calcific Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy (NIUT)

The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Lille, France
        • CHU Lille Insitut Coeur Poumon
      • Paris, France
        • Hopital Europeen Georges Pompidou
      • Paris, France
        • Hopital Bichat Claude-Bernard
      • Reims, France
        • CHU Reims Hopital Robert Debre
      • Rouen, France
        • CHU Rouen Hopital Charles Nicole
      • Toulouse, France, 31076
        • Clinique Pasteur
  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoff-Klinik
      • Hamburg, Germany
        • Marienkrankenhaus
  • Netherlands
      • Amsterdam, Netherlands, 1091 AC
        • OLVG
      • Breda, Netherlands
        • Amphia Hospital
      • Nijmegen, Netherlands, 6525 AG
        • Radboudumc

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject suffering from severe symptomatic calcific aortic valve stenosis as defined by ESC/EACTS guidelines for the management of valvular heart disease 2021; and
  2. Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or
  3. Subject who refuses TAVR/SAVR, documented by local HEART Team (not allowed in France); and
  4. Age ≥18 years; and
  5. Subject willing to provide a written informed consent prior to participating in the study; and
  6. Subject who can comply with the study follow-up or other study requirements; and
  7. Subject is eligible for the Valvosoft procedure according to Clinical Review Committee (CRC).

Exclusion Criteria:

  1. Subject with severe aortic regurgitation; or
  2. Subject with unstable arrhythmia not controlled by medical treatment; or
  3. Subjects with implanted mechanical valve in any position or bio-prosthetic valve in aortic position; or
  4. Subject has a chest deformity not allowing optimal placement of Valvosoft Applicator and visualization of the aortic valve; or
  5. Cardiogenic shock or other hemodynamic instability; or
  6. Left Ventricular Ejection Fraction ≤30%; or
  7. Subject with mean AVAI <0,24 cm²/m2; or
  8. History of heart transplant; or
  9. Subject requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after Valvosoft procedure; or
  10. Cardiac imaging evidence of vegetation; or
  11. Acute myocardial infarction (MI) within one month prior to enrolment; or
  12. Valve depth not suitable for NIUT (depth >125mm with respect to the Valvosoft imaging probe); or
  13. Stroke or transient ischemic attack (TIA) ≤1 month prior to enrollment; or
  14. Subject who is pregnant, or plan to become pregnant during the 12-months study follow-up period; or
  15. Subject who is participating in another research study for which the primary endpoint has not been reached; or
  16. Balloon aortic valvuloplasty (BAV) ≤3 months prior to enrollment; or
  17. Current endocarditis; or
  18. Leukopenia (WBC <4000 cell/μL), anemia (Hgb <8 g/dL), thrombocytopenia (platelet count <15.000 cell/μL), or history of coagulopathy or hypercoagulable state; or
  19. Life expectancy < 6 months due to non-cardiac co-morbid conditions; or
  20. Other medical, psychological, or social condition which, in the opinion of the investigator, precludes the subject from study participation; or
  21. Subjects who do not have Social Security and who are under legal restraint; or
  22. Subjects who cannot read or write or are mentally not or partially capable of giving informed consent.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Valvosoft
Treatment with VALVOSOFT device
Device: VALVOSFT intervention
Treatment of the calcific aorta valve by non-invasive ultrasound therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety endpoint
Time Frame: at 30 days post-procedure
Rate of MACE < 25%
at 30 days post-procedure
Performance endpoint
Time Frame: at 30 days post-procedure
Improvement in clinical status assessed by means of a decrease in NHYA functional class
at 30 days post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of MACE
Time Frame: peri-procedureal, and at 3-, 6- and 12 months post procedure
Rate of major adverse and cerebral events
peri-procedureal, and at 3-, 6- and 12 months post procedure
All cause mortality
Time Frame: 30 days, 3-, 6- and 12-months post procedure
All cause mortality
30 days, 3-, 6- and 12-months post procedure
Rate of Stroke
Time Frame: 30 days, 3-, 6- and 12-months post procedure;
Rate of stroke (disabling and non-disabling; ischemic and hemorrhagic)
30 days, 3-, 6- and 12-months post procedure;
AVA change at 30 days
Time Frame: 30 days post procedure
Change of 10% in of aortic stenosis by means of aortic valve area (AVA) (assessed by the independent echocardiographic Central Core Laboratory) 30 days post procedure compared to baseline
30 days post procedure
AVA change in severity
Time Frame: at 6- and 12 months
Change in severity of aortic stenosis by means of aortic valve area (AVA) (assessed by the independent echocardiographic Central Core Laboratory) at 6- and 12 months compared to baseline
at 6- and 12 months
NYHA improvement
Time Frame: 3-, 6- and 12-months
Change in clinical status assessed by means of a decrease in NYHA functional class
3-, 6- and 12-months
Change in 6 minutes walk test
Time Frame: 30 days, 6- and 12 months
Change in 6-minutes' walk test
30 days, 6- and 12 months
Improvement of quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 30 days, 6-, and 12-months
Improvement of quality of life by means of KCCQ. KCCQ is a 23-item, self-administered questionnaire
30 days, 6-, and 12-months
Improvement of quality of life by EQ-5D
Time Frame: 30 days, 6-, and 12-months
Improvement of quality of life by means of EQ-5D. The EQ-5D descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
30 days, 6-, and 12-months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardiawave SA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
QbD Clinical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian Spaulding, MD, PhD, HEGP, Paris, France

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CW21-02

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

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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