Mitral Valve InsufficiencyNCT02322840
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
A study testing Twelve TMVR Implant and Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System in people with Mitral Valve Insufficiency, run by Medtronic Cardiovascular at 32 sites in 7 countries.
Trial summary
PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients. EFS: The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral… 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?
- Twelve TMVR Implant and Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 32 sitesin 7 countries
- Study dates
- Apr 2015to Dec 2028
- Phase
- Interventional
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 (PILOT)
- moderate-severe or severe mitral regurgitation (EFS)
- Symptomatic mitral regurgitation (NYHA Class II-IV)
- Deemed to be at high risk for conventional mitral valve surgery by the local heart team (including, at minimum, a cardiac surgeon, interventional cardiologist, and an echocardiologist) (PILOT and EFS)
- Subjects anatomically suitable for the Intrepid TMVR delivery system, including transfemoral and transseptal access (EFS only)
- Native mitral valve geometry and size compatible with the Intrepid™ TMVR (PILOT)
Who cannot join
- Left ventricular ejection fraction (LVEF) < 20 (PILOT) or <30% (EFS)
- Evidence of intracardiac mass, thrombus, or vegetation
- Prior valve surgery or need for other valve surgery
- Prior stroke within 30 days (PILOT) or 90 days (EFS)
- Gastrointestinal bleeding within 6 months (PILOT)
- Prior myocardial infarction 90 days (EFS)
Show all 9Show fewer
- Need for coronary revascularization
- History of, or active, endocarditis if antibiotics are required (EFS)
- Renal insufficiency; Serum Creatinine > 2.5 mg/dL (PILOT) or Creatinine Clearance <30 cc/min (EFS)
Trial locations and contacts
32 sites in 7 countries.
32 sites in 7 countries
United States21 sites
University of Michigan Health System - University Hospital - PILOT
Ann Arbor, Michigan, 48109
Piedmont Atlanta Hospital - PILOT
Atlanta, Georgia, 30309
University of Virginia Medical Center - EFS
Charlottesville, Virginia, 22908
Northwestern Memorial Hospital - PILOT
Chicago, Illinois, 60208
Baylor Jack and Jane Hamilton Heart and Vascular Hospital - PILOT
Dallas, Texas, 75246
Corewell Health - EFS
Grand Rapids, Michigan, 49503
Houston Methodist Hospital - PILOT
Houston, Texas, 77030
Cedars-Sinai Medical Center - PILOT
Los Angeles, California, 90048
Aurora Saint Luke's Medical Center - EFS
Milwaukee, Wisconsin, 53215
Aurora Saint Lukes Medical Center - PILOT
Milwaukee, Wisconsin, 53215
Abbott Northwestern Hospital - EFS
Minneapolis, Minnesota, 55407
Abbott Northwestern Hospital - PILOT
Minneapolis, Minnesota, 55407
NYU Langone Medical Center - PILOT
New York, New York, 10016
The Mount Sinai Hospital (New York NY) - EFS
New York, New York, 10029
The Mount Sinai Hospital (New York NY) - PILOT
New York, New York, 10029
New York-Presbyterian Hospital Columbia University Medical Center - EFS
New York, New York, 10032
New York-Presbyterian Hospital Columbia University Medical Center - PILOT
New York, New York, 10032
Abrazo Arizona Heart Hospital - EFS
Phoenix, Arizona, 85016
Oregon Health & Science University Hospital - EFS
Portland, Oregon, 97239
Barnes Jewish Hospital - PILOT
St Louis, Missouri, 63110
UPMC Pinnacle Harrisburg Campus - EFS
Wormleysburg, Pennsylvania, 17043
Australia3 sites
Monash Health - PILOT
Clayton, Victoria, 3168
The Alfred Hospital - PILOT
Melbourne
Royal Prince Alfred Hospital - PILOT
Sydney
United Kingdom3 sites
Royal Sussex County Hospital - PILOT
Brighton
The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary - PILOT
Leeds, LS1 3EX
Guys & St Thomas NHS Foundation Trust - St Thomas Hospital - PILOT
London
France2 sites
Centre Hospitalier Régional Universitaire de Lille - PILOT
Lille
Clinique Pasteur - PILOT
Toulouse
About this study
Official title: An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Intrepid Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
PILOT:
The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients.
EFS:
The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with moderate-Severe or severe, Symptomatic Mitral Regurgitation
Read the detailed description
PILOT:
The study is a prospective, multi-center, non-randomized study to evaluate the safety and performance of The Intrepid™ TMVR System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.
EFS:
The study is a multi-center, prospective, non-randomized, trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Moderate-Severe or Severe, Symptomatic Mitral Regurgitation
- Conditions
- Mitral Valve Insufficiency
- Being tested
- Twelve TMVR Implant, Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement 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.
Twelve TMVR ImplantDevice
Also called Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System
Implantation of the Twelve TMVR System - Apical
Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement SystemDevice
Also called Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System
Implantation of the Medtronic Intrepid™ Transcatheter Mitral Valve- Transfemoral
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Mitral Valve Replacement (TMVR) Implant | Experimental | Twelve TMVR Implant Receives: Device: Twelve TMVR Implant; Device: Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects With Adverse Events
PILOT: Site Reported Serious Adverse Events Implant or Delivery Related Through 30-Days EFS: Implant, Delivery or device related serious adverse events through 30 days post procedure
Measured: 30 days
Secondary outcomes (9)
Number of Subjects With Procedural Success
PILOT: Successful access, delivery of implant, and retrieval of the delivery system EFS: Successful access, delivery of implant, and retrieval of the delivery system
Measured: Procedure
Change in Mitral Regurgitation (MR) From Baseline Through 30 Days
PILOT: Change in MR Grade from baseline measured by echo through 30 days post-procedure. Measured by Echo 30 days post procedure.
Measured: 30 days
Change in Mitral Regurgitation (MR) From Baseline Through 30 Days
EFS: Change in MR Grade from Baseline measured by echo through 30 days post-procedure. Measured by Echo 30 days post procedure.
Measured: Through 30 Days
Change in New York Heart Association (NYHA) From Baseline Through 30 Days
PILOT: Change in NYHA Class from Baseline through 30 days post-procedure.
Measured: Through 30 days
Change in New York Heart Association (NYHA) From Baseline Through 30 Days
EFS: Change in NYHA Class from Baseline through 30 days post procedure
Measured: Through 30 Days
Number of Subjects Without Mitral Valve Stenosis
PILOT: No significant mitral Valve (MV) Stenosis measured by echo through 30 days post-procedure EFS: No Significant Mitral Valve (MV) Stenosis measured by echo through 30 days post-procedure
Measured: Through 30 days
Number of Subject With Left Ventricle Output Tract (LVOT) Patency
PILOT: LVOT patency measured by echo through 30 days post-procedure.
Measured: Through 30 days
Percent of Subject With Left Ventricular Outflow Tract (LVOT) Patency
EFS: Left Ventricular Outflow Tract (LVOT) Patency measured by echo through 30 days post-procedure
Measured: 30 Days post procedure
Number of Subjects With Greater Than or Equal Moderate (2+) Mitral Regurgitation at 30-days
PILOT: Number of subjects with a core lab-evaluated mitral regurgitation grade greater than or equal to moderate at 30-days
Measured: Through 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startApr 2015
- Primary completion1 Sep 2022
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynnett Stahl, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322840
- Sponsor's protocol ID
- CIP-1403 & MDT19042TMV002
- Status last verified
- Dec 2025
- First submitted
- 31 Oct 2014
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tang GHL, Rajagopal V, Sorajja P, Bajwa T, Gooley R, Walton A, Modine T, Ng MK, Williams MR, Zajarias A, Hildick-Smith D, Tchetche D, Spargias K, Rajani R, Bapat VN, De Backer O, Blackman D, McCarthy P, Laine M, Jain R, Martin R, Thaden JJ, Marka NA, Mack M, Adams DH, Leon MB, Reardon MJ. Five-year outcomes of the early-generation Intrepid transapical transcatheter mitral valve replacement system. EuroIntervention. 2026 Feb 2;22(3):e172-e182. doi: 10.4244/EIJ-D-25-01133.
PubMed 41251714Zahr F, Song HK, Chadderdon SM, Gada H, Mumtaz M, Byrne T, Kirshner M, Bajwa T, Weiss E, Kodali S, George I, Heiser J, Merhi WM, Thaden JJ, Zhang A, Lim DS, Reardon MJ, Adams DH, Mack MJ, Leon MB. 30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results. JACC Cardiovasc Interv. 2022 Jan 10;15(1):80-89. doi: 10.1016/j.jcin.2021.10.018. Epub 2021 Nov 6.
PubMed 34747699Bapat V, Rajagopal V, Meduri C, Farivar RS, Walton A, Duffy SJ, Gooley R, Almeida A, Reardon MJ, Kleiman NS, Spargias K, Pattakos S, Ng MK, Wilson M, Adams DH, Leon M, Mack MJ, Chenoweth S, Sorajja P; Intrepid Global Pilot Study Investigators. Early Experience With New Transcatheter Mitral Valve Replacement. J Am Coll Cardiol. 2018 Jan 2;71(1):12-21. doi: 10.1016/j.jacc.2017.10.061. Epub 2017 Nov 16.
PubMed 29102689