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.
Brief Title
AMENDTM Mitral Valve Repair System, Annuloplasty Ring Applied in a Transcatheter Method
Completion Date
Completion Date Type
Actual
Conditions
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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02602613
Org Class
Industry
Org Full Name
Valcare Medical Ltd.
Org Study Id
CL4-0001P
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
AMEND I Study - for the Valcare Medical AMEND TM Mitral Valve Repair System
Primary Outcomes
Outcome Description
Freedom from major SAE's at 30 days following procedure
Outcome Measure
Safety - Freedom from major SAE's at 30 days following procedure
Outcome Time Frame
30 days
Outcome Description
Ring location and attachment based on echocardiography
Outcome Measure
Technical success of implantation
Outcome Time Frame
End of procedure
Secondary Outcomes
Outcome Description
Freedom from major SAE's at 6 months following procedure
Outcome Time Frame
6 months
Outcome Measure
Safety - Freedom from major SAE's at 6 months following procedure
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mohamed Azeem Latib
Investigator Email
mlatib@montefiore.org
Investigator Phone
646-773-2076
Investigator Department
Medicine
Investigator Division
Cardiology
Investigator Sponsor Organization
Montefiore
Study Department
Medicine
Study Division
Cardiology
Categories Mesh Debug
Heart/Cardiovascular --- HEART VALVE DISEASES
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
MITRAL VALVE INSUFFICIENCY
HEART VALVE DISEASES
HEART DISEASES
CARDIOVASCULAR DISEASES