AMENDTM Mitral Valve Repair System, Annuloplasty Ring Applied in a Transcatheter Method
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mitral Regurgitation | Device: AMEND Mitral Valve Repair System | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: AMEND |
Device: AMEND Mitral Valve Repair System
Annuloplasty ring applied in a transcatheter method |
- 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
- Technical success of implantation [ Time Frame: End of procedure ]Ring location and attachment based on echocardiography
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
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 |
Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |