Back to resultsAMENDTM Mitral Valve Repair System, Annuloplasty Ring Applied in a Transcatheter Method
Primary Purpose
Mitral Regurgitation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AMEND Mitral Valve Repair System
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Regurgitation
Eligibility Criteria
Inclusion Criteria:
- Patient age ≥18
- The patient requires mitral valve annuloplasty for mitral regurgitation without the need for concomitant cardiovascular surgical procedures
- NYHA functional capacity ≥2
- The subject is high risk to undergo a mitral valve surgery as assessed by the center heart team
- The patient is willing to comply with study procedures and is available to return to the implant center for follow-up visits.
- The patient is willing to provide Informed consent
Exclusion Criteria:
- Cardiac or non-cardiac major or progressive disease, which in the investigator's discretion produces an unacceptable increased risk to the patient.
- Life expectancy of less than twelve months.
- Heavily calcified annulus or leaflets.
- Previous or active endocarditis.
- Active infection.
- A previously implanted prosthetic mitral valve or annuloplasty ring/band.
- The patient is contraindicated to general anesthesia.
- Pregnant (urine HCG test result positive) or lactating patient.
- Drug or alcohol abuse.
- Participation in concomitant research studies of investigational products that will interfere with the study.
Sites / Locations
- ZNA Middelheim Hospital
- Na Homolce Hospital
- Shaare Zedek Medical Center
- Sheba Medical Center
- Azienda Ospedaliera Di Padova
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AMEND
Arm Description
Outcomes
Primary Outcome Measures
Safety - Freedom from major SAE's at 30 days following procedure
Freedom from major SAE's at 30 days following procedure
Technical success of implantation
Ring location and attachment based on echocardiography
Secondary Outcome Measures
Safety - Freedom from major SAE's at 6 months following procedure
Freedom from major SAE's at 6 months following procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02602613
Brief Title
AMENDTM Mitral Valve Repair System, Annuloplasty Ring Applied in a Transcatheter Method
Official Title
AMEND I Study - for the Valcare Medical AMEND TM Mitral Valve Repair System
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valcare Medical Ltd.
4. Oversight
5. Study Description
Brief Summary
A multi center study to evaluate the safety of the AMENDTM Mitral Valve Repair System and its ability to reduce mitral regurgitation. AMEND device is an annuloplasty ring implanted in a minimally invasive trans-catheter method.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMEND
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AMEND Mitral Valve Repair System
Intervention Description
Annuloplasty ring applied in a transcatheter method
Primary Outcome Measure Information:
Title
Safety - Freedom from major SAE's at 30 days following procedure
Description
Freedom from major SAE's at 30 days following procedure
Time Frame
30 days
Title
Technical success of implantation
Description
Ring location and attachment based on echocardiography
Time Frame
End of procedure
Secondary Outcome Measure Information:
Title
Safety - Freedom from major SAE's at 6 months following procedure
Description
Freedom from major SAE's at 6 months following procedure
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient age ≥18
The patient requires mitral valve annuloplasty for mitral regurgitation without the need for concomitant cardiovascular surgical procedures
NYHA functional capacity ≥2
The subject is high risk to undergo a mitral valve surgery as assessed by the center heart team
The patient is willing to comply with study procedures and is available to return to the implant center for follow-up visits.
The patient is willing to provide Informed consent
Exclusion Criteria:
Cardiac or non-cardiac major or progressive disease, which in the investigator's discretion produces an unacceptable increased risk to the patient.
Life expectancy of less than twelve months.
Heavily calcified annulus or leaflets.
Previous or active endocarditis.
Active infection.
A previously implanted prosthetic mitral valve or annuloplasty ring/band.
The patient is contraindicated to general anesthesia.
Pregnant (urine HCG test result positive) or lactating patient.
Drug or alcohol abuse.
Participation in concomitant research studies of investigational products that will interfere with the study.
Facility Information:
Facility Name
ZNA Middelheim Hospital
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Na Homolce Hospital
City
Prague
ZIP/Postal Code
15030
Country
Czechia
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Azienda Ospedaliera Di Padova
City
Padova
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
AMENDTM Mitral Valve Repair System, Annuloplasty Ring Applied in a Transcatheter Method
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