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AMENDTM Mitral Valve Repair System, Annuloplasty Ring Applied in a Transcatheter Method

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602613
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Valcare Medical Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Device: AMEND Mitral Valve Repair System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AMEND I Study - for the Valcare Medical AMEND TM Mitral Valve Repair System
Study Start Date : December 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: AMEND Device: AMEND Mitral Valve Repair System
Annuloplasty ring applied in a transcatheter method


Outcome Measures
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Primary Outcome Measures :
  1. Safety - Freedom from major SAE's at 30 days following procedure [ Time Frame: 30 days ]
    Freedom from major SAE's at 30 days following procedure

  2. Technical success of implantation [ Time Frame: End of procedure ]
    Ring location and attachment based on echocardiography


Secondary Outcome Measures :
  1. Safety - Freedom from major SAE's at 6 months following procedure [ Time Frame: 6 months ]
    Freedom from major SAE's at 6 months following procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602613


Locations
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Belgium
ZNA Middelheim Hospital
Antwerpen, Belgium, 2020
Czechia
Na Homolce Hospital
Prague, Czechia, 15030
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Sheba Medical Center
Ramat Gan, Israel, 5265601
Italy
Azienda Ospedaliera Di Padova
Padova, Italy
Sponsors and Collaborators
Valcare Medical Ltd.
More Information
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Responsible Party: Valcare Medical Ltd.
ClinicalTrials.gov Identifier: NCT02602613    
Other Study ID Numbers: CL4-0001P
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: October 2017
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases