Mitral RegurgitationNCT02602613
AMENDTM Mitral Valve Repair System, Annuloplasty Ring Applied in a Transcatheter Method
A study testing AMEND Mitral Valve Repair System in people with Mitral Regurgitation, run by Valcare Medical Ltd. at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- AMEND Mitral Valve Repair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Dec 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Israel2 sites
Shaare Zedek Medical Center
Jerusalem, 9103102
Sheba Medical Center
Ramat Gan, 5265601
About this study
Official title: AMEND I Study - for the Valcare Medical AMEND TM Mitral Valve Repair System
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.
- Conditions
- Mitral Regurgitation
- Being tested
- AMEND Mitral Valve Repair System
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMEND Mitral Valve Repair SystemDevice
Annuloplasty ring applied in a transcatheter method
| Study group | Role | What they receive |
|---|---|---|
| AMEND | Experimental | Not described Receives: Device: AMEND Mitral Valve Repair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Freedom from major SAE's at 30 days following procedure
Freedom from major SAE's at 30 days following procedure
Measured: 30 days
Technical success of implantation
Ring location and attachment based on echocardiography
Measured: End of procedure
Secondary outcomes (1)
Safety - Freedom from major SAE's at 6 months following procedure
Freedom from major SAE's at 6 months following procedure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valcare Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602613
- Sponsor's protocol ID
- CL4-0001P
- Status last verified
- Oct 2017
- First submitted
- 9 Nov 2015
- Last updated
- 3 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMEND I Study - for the Valcare Medical AMEND TM Mitral Valve Repair System
- ClinicalTrials.gov ID
- NCT02602613
- Acronym / sponsor ID
- CL4-0001P
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Valcare Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMEND | Experimental | Device: AMEND Mitral Valve Repair System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMEND Mitral Valve Repair SystemAnnuloplasty ring applied in a transcatheter method | Device | AMEND |
Primary outcome
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
1 secondary outcome
Safety - Freedom from major SAE's at 6 months following procedure
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMEND Mitral Valve Repair System in people with Mitral Regurgitation, run by Valcare Medical Ltd. at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel, Belgium, Czechia, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Freedom from major SAE's at 30 days following procedure (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.