Mitral Valve InsufficiencyNCT02428010
Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study
A study testing TMVR Implant in people with Mitral Valve Insufficiency, run by Medtronic Cardiovascular at 1 site in Poland.
Trial summary
Study to evaluate the safety and performance of the Twelve TMVR System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- TMVR Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2014to Apr 2021
- 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
- Severe mitral regurgitation (MR Grade 3-4+)
- Symptomatic mitral regurgitation (NYHA Class II-IV)
- Trans-apical access deemed feasible by the treating physician
- Native mitral valve geometry and size compatible with the Twelve TMVR
Who cannot join
- Left ventricular ejection fraction (LVEF) < 20
- Evidence of intracardiac mass, thrombus, or vegetation
- Prior valve surgery or need for other valve surgery
- Prior stroke within 4 weeks
- Need for coronary revascularization
- History of, or active, endocarditis
- Renal insufficiency (Creatinine > 2.5 mg/dL)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
Study to evaluate the safety and performance of the Twelve TMVR System
Read the detailed description
The study is a prospective, multi-center, non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high risk patients with severe, symptomatic mitral regurgitation.
- Conditions
- Mitral Valve Insufficiency
- Being tested
- TMVR Implant
- 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.
TMVR ImplantDevice
Implantation of the Twelve TMVR System
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | TMVR Implant Receives: Device: TMVR Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of patients with adverse events associated with the delivery and/or implantation of the device
Measured: 30 days
Secondary outcomes (2)
Procedural Success
Number of patients with successful TMVR implant
Measured: Through 5 years
Reduction of MR
Number of patients with a reduction of MR Grade
Measured: Through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionApr 2021
- Study completionApr 2021
Why it stopped: Site has not reliably responded Medtronic team since the transition from sponsor Twelve. No data entry completed since February 2018. Last study subject passed final study visit window. No data is expected to be entered.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sonia Diaz de Leon, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428010
- Sponsor's protocol ID
- CIP-1402
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2015
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT02428010
- Acronym / sponsor ID
- CIP-1402
- Conditions
- Mitral Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Site has not reliably responded Medtronic team since the transition from sponsor Twelve. No data entry completed since February 2018. Last study subject passed final study visit window. No data is expected to be entered.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 28 Apr 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.
Study to evaluate the safety and performance of the Twelve TMVR System
Detailed description
The study is a prospective, multi-center, non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high risk patients with severe, symptomatic mitral regurgitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: TMVR ImplantTMVR Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Severe mitral regurgitation (MR Grade 3-4+)
- Symptomatic mitral regurgitation (NYHA Class II-IV)
- Trans-apical access deemed feasible by the treating physician
- Native mitral valve geometry and size compatible with the Twelve TMVR
Key exclusion criteria (7 listed)
- Left ventricular ejection fraction (LVEF) < 20
- Evidence of intracardiac mass, thrombus, or vegetation
- Prior valve surgery or need for other valve surgery
- Prior stroke within 4 weeks
- Need for coronary revascularization
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 |
|---|---|---|
| TMVR ImplantImplantation of the Twelve TMVR System | Device | Treatment |
Primary outcome
Adverse Events
Time frame: 30 days
Number of patients with adverse events associated with the delivery and/or implantation of the device
2 secondary outcomes
Procedural Success
Time frame: Through 5 years
Reduction of MR
Time frame: Through 5 years
Results and safety
The study was stopped early (reason given: Site has not reliably responded Medtronic team since the transition from sponsor Twelve. No data entry completed since February 2018. Last study subject passed final study visit window. No data is expected to be entered.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
Related trials for Mitral Valve Insufficiency
Recruiting
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Mitral Valve Regurgitation
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
RecruitingObservational study
Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population
Mitral Valve Insufficiency
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
Not yet recruiting
The PALMETTO Study
Mitral Regurgitation
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.
Sonia Diaz de Leon study director
Medtronic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMVR Implant in people with Mitral Valve Insufficiency, run by Medtronic Cardiovascular at 1 site in Poland.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 was stopped early (reason given: Site has not reliably responded Medtronic team since the transition from sponsor Twelve. No data entry completed since February 2018. Last study subject passed final study visit window. No data is expected to be entered.). Results are not available in the source record.
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?
Adverse Events (time frame: 30 days). 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 4 May 2021; AzTrials last refreshed its copy on 31 Oct 2026.