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VALVOSOFT® Pivotal Study

Primary Purpose

Aortic Valve Calcification, Aortic Valve Stenosis

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
VALVOSFT intervention
Sponsored by
Cardiawave SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aortic Valve Calcification focused on measuring Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve, Stenosis, Ultrasound, non invasive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; 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.

Sites / Locations

  • CHU Lille Insitut Coeur Poumon
  • Hopital Bichat Claude-Bernard
  • Hopital Europeen Georges Pompidou
  • CHU Reims Hopital Robert Debré
  • CHU Rouen Hopital Charles Nicole
  • Clinique Pasteur
  • Kerckhoff-klinik
  • Marienkrankenhaus
  • OLVG
  • Amphia Hospital
  • Radboudumc

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Valvosoft

Arm Description

Treatment with VALVOSOFT device

Outcomes

Primary Outcome Measures

Safety endpoint
Rate of MACE < 25%
Performance endpoint
Improvement in clinical status assessed by means of a decrease in NHYA functional class

Secondary Outcome Measures

Rate of MACE
Rate of major adverse and cerebral events
All cause mortality
All cause mortality
Rate of Stroke
Rate of stroke (disabling and non-disabling; ischemic and hemorrhagic)
AVA change at 30 days
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
AVA change in severity
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
NYHA improvement
Change in clinical status assessed by means of a decrease in NYHA functional class
Change in 6 minutes walk test
Change in 6-minutes' walk test
Improvement of quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Improvement of quality of life by means of KCCQ. KCCQ is a 23-item, self-administered questionnaire
Improvement of quality of life by EQ-5D
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.

Full Information

First Posted
January 20, 2022
Last Updated
July 17, 2023
Sponsor
Cardiawave SA
Collaborators
QbD Clinical
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1. Study Identification

Unique Protocol Identification Number
NCT05235568
Brief Title
VALVOSOFT® Pivotal Study
Official Title
Prospective, Single-arm Pivotal Study for the Treatment of Subjects With Severe Symptomatic Calcific Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy (NIUT)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
August 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiawave SA
Collaborators
QbD Clinical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Calcification, Aortic Valve Stenosis
Keywords
Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve, Stenosis, Ultrasound, non invasive

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Valvosoft
Arm Type
Other
Arm Description
Treatment with VALVOSOFT device
Intervention Type
Device
Intervention Name(s)
VALVOSFT intervention
Intervention Description
Treatment of the calcific aorta valve by non-invasive ultrasound therapy
Primary Outcome Measure Information:
Title
Safety endpoint
Description
Rate of MACE < 25%
Time Frame
at 30 days post-procedure
Title
Performance endpoint
Description
Improvement in clinical status assessed by means of a decrease in NHYA functional class
Time Frame
at 30 days post-procedure
Secondary Outcome Measure Information:
Title
Rate of MACE
Description
Rate of major adverse and cerebral events
Time Frame
peri-procedureal, and at 3-, 6- and 12 months post procedure
Title
All cause mortality
Description
All cause mortality
Time Frame
30 days, 3-, 6- and 12-months post procedure
Title
Rate of Stroke
Description
Rate of stroke (disabling and non-disabling; ischemic and hemorrhagic)
Time Frame
30 days, 3-, 6- and 12-months post procedure;
Title
AVA change at 30 days
Description
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
Time Frame
30 days post procedure
Title
AVA change in severity
Description
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
Time Frame
at 6- and 12 months
Title
NYHA improvement
Description
Change in clinical status assessed by means of a decrease in NYHA functional class
Time Frame
3-, 6- and 12-months
Title
Change in 6 minutes walk test
Description
Change in 6-minutes' walk test
Time Frame
30 days, 6- and 12 months
Title
Improvement of quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Improvement of quality of life by means of KCCQ. KCCQ is a 23-item, self-administered questionnaire
Time Frame
30 days, 6-, and 12-months
Title
Improvement of quality of life by EQ-5D
Description
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.
Time Frame
30 days, 6-, and 12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject suffering from severe symptomatic calcific aortic valve stenosis as defined by ESC/EACTS guidelines for the management of valvular heart disease 2021; and Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or Subject who refuses TAVR/SAVR, documented by local HEART Team (not allowed in France); and Age ≥18 years; and Subject willing to provide a written informed consent prior to participating in the study; and Subject who can comply with the study follow-up or other study requirements; and Subject is eligible for the Valvosoft procedure according to Clinical Review Committee (CRC). Exclusion Criteria: Subject with severe aortic regurgitation; or Subject with unstable arrhythmia not controlled by medical treatment; or Subjects with implanted mechanical valve in any position or bio-prosthetic valve in aortic position; or Subject has a chest deformity not allowing optimal placement of Valvosoft Applicator and visualization of the aortic valve; or Cardiogenic shock or other hemodynamic instability; or Left Ventricular Ejection Fraction ≤30%; or Subject with mean AVAI <0,24 cm²/m2; or History of heart transplant; or Subject requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after Valvosoft procedure; or Cardiac imaging evidence of vegetation; or Acute myocardial infarction (MI) within one month prior to enrolment; or Valve depth not suitable for NIUT (depth >125mm with respect to the Valvosoft imaging probe); or Stroke or transient ischemic attack (TIA) ≤1 month prior to enrollment; or Subject who is pregnant, or plan to become pregnant during the 12-months study follow-up period; or Subject who is participating in another research study for which the primary endpoint has not been reached; or Balloon aortic valvuloplasty (BAV) ≤3 months prior to enrollment; or Current endocarditis; or 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 Life expectancy < 6 months due to non-cardiac co-morbid conditions; or Other medical, psychological, or social condition which, in the opinion of the investigator, precludes the subject from study participation; or Subjects who do not have Social Security and who are under legal restraint; or Subjects who cannot read or write or are mentally not or partially capable of giving informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Spaulding, MD, PhD
Organizational Affiliation
HEGP, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Lille Insitut Coeur Poumon
City
Lille
Country
France
Facility Name
Hopital Bichat Claude-Bernard
City
Paris
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
Country
France
Facility Name
CHU Reims Hopital Robert Debré
City
Reims
Country
France
Facility Name
CHU Rouen Hopital Charles Nicole
City
Rouen
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Kerckhoff-klinik
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Marienkrankenhaus
City
Hamburg
Country
Germany
Facility Name
OLVG
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Amphia Hospital
City
Breda
Country
Netherlands
Facility Name
Radboudumc
City
Nijmegen
ZIP/Postal Code
6525 AG
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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VALVOSOFT® Pivotal Study

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