Trial Outcomes & Findings for Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System (NCT NCT02322840)

Last Updated: 2026-01-14

Results Overview

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

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

128 participants

Primary outcome timeframe

30 days

Results posted on

2026-01-14

Participant Flow

Patient recruitment occurred April 2015 to March 2019 at 23 sites (12 U.S.,3 Australia, 8 Europe)(PILOT), Jan. 2020 to Aug. 2022 at 11 U.S sites (EFS). Patients with severe, symptomatic mitral regurgitation at high surgical risk (PILOT) or moderate-severe or severe, symptomatic mitral regurgitation, ineligible for conventional mitral valve surgery (EFS) were screened for eligibility, provided informed consent, met all inclusion criteria, and no exclusion criteria, were enrolled.

These are single-arm studies. Patients who signed informed consent \& fulfill inclusion criteria and none of the exclusion criteria listed below are eligible for enrollment. A Patient Review Committee (PRC) (PILOT)/ Screening Committee (EFS), which consisted of cardiac surgery, interventional cardiology, and echocardiology representatives who were not participating investigators, reviewed potential patients' clinical and imaging data to help ensure appropriate patient selection across all sites.

Participant milestones

Participant milestones
Measure	Transcatheter Mitral Valve Replacement (TMVR) Implant Twelve TMVR Implant Twelve TMVR Implant: Implantation of the Twelve TMVR System -Apical Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System: Implant of Intrepid valve -Transfemoral
Overall Study STARTED	128
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	70

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PILOT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcatheter Mitral Valve Replacement (TMVR) Implant n=128 Participants Twelve TMVR Implant: Implantation of the Twelve TMVR System -Apical Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System: Implant of Intrepid valve -Transfemoral
Race/Ethnicity, Customized Asian	2 Paticipants n=95 Participants • PILOT
Age, Continuous	78.6 years STANDARD_DEVIATION 7.4 • n=33 Participants • EFS
Sex: Female, Male Female	12 Participants n=33 Participants • EFS
Sex: Female, Male Male	21 Participants n=33 Participants • EFS
Race/Ethnicity, Customized Caucasian	81 Paticipants n=95 Participants • PILOT
Race/Ethnicity, Customized Hispanic or Latino	3 Paticipants n=95 Participants • PILOT
Race/Ethnicity, Customized Black or African American	9 Paticipants n=95 Participants • PILOT
Race/Ethnicity, Customized RAC and Ethnicity Not Collected	0 Participants Data not collected for EFS participants
Region of Enrollment Greece	3 Participants n=95 Participants • PILOT
Region of Enrollment United States	33 Participants n=33 Participants • EFS
Region of Enrollment Denmark	2 Participants n=95 Participants • PILOT
Region of Enrollment United Kingdom	9 Participants n=95 Participants • PILOT
Region of Enrollment Australia	19 Participants n=95 Participants • PILOT
Region of Enrollment France	9 Participants n=95 Participants • PILOT
Region of Enrollment Finland	1 Participants n=95 Participants • PILOT
STS Score - PROM (MV Replacement Only)	6.5 % risk of mortality STANDARD_DEVIATION 4.8 • n=95 Participants • PILOT
STS Score- PROM (MV Replacement only)	5.3 % risk of mortality STANDARD_DEVIATION 2.8 • n=33 Participants • EFS
Creatinine Clearance	61.4 cc/min STANDARD_DEVIATION 25.7 • n=33 Participants • EFS
NYHA Class NYHA I	0.0 Participants n=95 Participants • PILOT
NYHA Class NYHA II	11 Participants n=95 Participants • PILOT
NYHA Class NYHA III	71 Participants n=95 Participants • PILOT
NYHA Class NYHA IV	13 Participants n=95 Participants • PILOT
NYHA Class NYHA l	0 Participants n=33 Participants • EFS
NYHA Class NYHA ll	10 Participants n=33 Participants • EFS
NYHA Class NYHA lll	22 Participants n=33 Participants • EFS
NYHA Class NYHA lV	1 Participants n=33 Participants • EFS
Previous Myocardial infarction	9 Participants n=33 Participants • EFS
Previous Cardiovascular Surgery	16 Participants n=33 Participants • EFS
Mitral Valve Etiology Primary	20 Participants n=33 Participants • EFS
Mitral Valve Etiology Secondary	13 Participants n=33 Participants • EFS
Atrial Fibrillation	15 Participants n=32 Participants • EFS
EUROSCORE II (%)	8.0 % risk of mortality STANDARD_DEVIATION 6.7 • n=95 Participants • PILOT

PRIMARY outcome

Timeframe: 30 days

Population: PILOT: 95 participants EFS: 33 participants

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

Outcome measures

Outcome measures
Measure	Transcatheter Mitral Valve Replacement (TMVR) Implant n=128 Participants Twelve TMVR Implant Twelve TMVR Implant: Implantation of the Twelve TMVR System -Apical Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System: Implant of Intrepid valve -Transfemoral
Percent of Subjects With Adverse Events PILOT	67 % of subjects with Event
Percent of Subjects With Adverse Events EFS Implant or Delivery Related	72.7 % of subjects with Event
Percent of Subjects With Adverse Events EFS Device Related	36.4 % of subjects with Event

SECONDARY outcome

Timeframe: Procedure

Population: PILOT: One subject had their procedure aborted prior to delivery catheter insertion and was thus excluded from deployment and retrieval denominator

PILOT: Successful access, delivery of implant, and retrieval of the delivery system EFS: Successful access, delivery of implant, and retrieval of the delivery system

Outcome measures

Outcome measures
Measure	Transcatheter Mitral Valve Replacement (TMVR) Implant n=128 Participants Twelve TMVR Implant Twelve TMVR Implant: Implantation of the Twelve TMVR System -Apical Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System: Implant of Intrepid valve -Transfemoral
Number of Subjects With Procedural Success PILOT: Successful access	94 Participants
Number of Subjects With Procedural Success PILOT: Successful Delivery of implant	90 Participants
Number of Subjects With Procedural Success PILOT: Successful retrieval of the delivery system	94 Participants
Number of Subjects With Procedural Success EFS: Procedural Success (Number of Patients with Successful TMVR Placement)	31 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Number of subjects with evaluable baseline and 30 day CoreLab echo MR grading.

PILOT: Change in MR Grade from baseline measured by echo through 30 days post-procedure. Measured by Echo 30 days post procedure.

Outcome measures

Outcome measures
Measure	Transcatheter Mitral Valve Replacement (TMVR) Implant n=71 Participants Twelve TMVR Implant Twelve TMVR Implant: Implantation of the Twelve TMVR System -Apical Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System: Implant of Intrepid valve -Transfemoral
Change in Mitral Regurgitation (MR) From Baseline Through 30 Days PILOT: Improved	71 Participants
Change in Mitral Regurgitation (MR) From Baseline Through 30 Days PILOT: No change	0 Participants
Change in Mitral Regurgitation (MR) From Baseline Through 30 Days PILOT: Worsened	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Transcatheter Mitral Valve Replacement (TMVR) Implant n=30 Participants Twelve TMVR Implant Twelve TMVR Implant: Implantation of the Twelve TMVR System -Apical Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System: Implant of Intrepid valve -Transfemoral
Change in Mitral Regurgitation (MR) From Baseline Through 30 Days Improved	30 Participants
Change in Mitral Regurgitation (MR) From Baseline Through 30 Days No change	0 Participants
Change in Mitral Regurgitation (MR) From Baseline Through 30 Days Worsened	0 Participants

SECONDARY outcome

Timeframe: Through 30 days

Population: PILOT: Number of subjects with evaluable baseline and 30 days NYHA classification.

PILOT: Change in NYHA Class from Baseline through 30 days post-procedure.

Outcome measures

Outcome measures
Measure	Transcatheter Mitral Valve Replacement (TMVR) Implant n=93 Participants Twelve TMVR Implant Twelve TMVR Implant: Implantation of the Twelve TMVR System -Apical Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System: Implant of Intrepid valve -Transfemoral
Change in New York Heart Association (NYHA) From Baseline Through 30 Days Improved	54 Participants
Change in New York Heart Association (NYHA) From Baseline Through 30 Days No change	20 Participants
Change in New York Heart Association (NYHA) From Baseline Through 30 Days Worsened	1 Participants
Change in New York Heart Association (NYHA) From Baseline Through 30 Days Died Prior to Visit	18 Participants

SECONDARY outcome

Timeframe: Through 30 Days

EFS: Change in NYHA Class from Baseline through 30 days post procedure

Outcome measures

Outcome measures
Measure	Transcatheter Mitral Valve Replacement (TMVR) Implant n=30 Participants Twelve TMVR Implant Twelve TMVR Implant: Implantation of the Twelve TMVR System -Apical Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System: Implant of Intrepid valve -Transfemoral
Change in New York Heart Association (NYHA) From Baseline Through 30 Days Died Prior to Visit	0 Participants
Change in New York Heart Association (NYHA) From Baseline Through 30 Days Worsened	3 Participants
Change in New York Heart Association (NYHA) From Baseline Through 30 Days Improved	21 Participants
Change in New York Heart Association (NYHA) From Baseline Through 30 Days No Change	6 Participants

SECONDARY outcome

Timeframe: Through 30 days

Population: PILOT: N= 62. Number of subjects with evaluable baseline and 30 day CoreLab echoes for MV stenosis; defined as an MV mean gradient \< 5 mmHg and effective orifice area (EOA) ≥ 1.5 cm² based on echocardiography core lab data. EFS: N=25. Number of subjects with EOA \>= 1.5 cm2, Transmitral Gradient \<5 mmHg, PVL \<=Mild, and No Hemolysis with PVL

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

Outcome measures

Outcome measures
Measure	Transcatheter Mitral Valve Replacement (TMVR) Implant n=87 Participants Twelve TMVR Implant Twelve TMVR Implant: Implantation of the Twelve TMVR System -Apical Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System: Implant of Intrepid valve -Transfemoral
Number of Subjects Without Mitral Valve Stenosis PILOT	19 Participants
Number of Subjects Without Mitral Valve Stenosis EFS	11 Participants

SECONDARY outcome

Timeframe: Through 30 days

Population: Number of subjects with evaluable baseline and 30 day CoreLab echoes for LVOT patency.

PILOT: LVOT patency measured by echo through 30 days post-procedure.

Outcome measures

Outcome measures
Measure	Transcatheter Mitral Valve Replacement (TMVR) Implant n=65 Participants Twelve TMVR Implant Twelve TMVR Implant: Implantation of the Twelve TMVR System -Apical Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System: Implant of Intrepid valve -Transfemoral
Number of Subject With Left Ventricle Output Tract (LVOT) Patency	62 Participants

SECONDARY outcome

Timeframe: 30 Days post procedure

Population: Number of subjects with evaluable baseline and 30 day CoreLab echoes for LVOT patency.

EFS: Left Ventricular Outflow Tract (LVOT) Patency measured by echo through 30 days post-procedure

Outcome measures

Outcome measures
Measure	Transcatheter Mitral Valve Replacement (TMVR) Implant n=29 Participants Twelve TMVR Implant Twelve TMVR Implant: Implantation of the Twelve TMVR System -Apical Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System: Implant of Intrepid valve -Transfemoral
Percent of Subject With Left Ventricular Outflow Tract (LVOT) Patency	100 Percent

SECONDARY outcome

Timeframe: Through 30 days

Population: Number of subjects with a core lab-evaluated mitral regurgitation grade greater than or equal to moderate at 30-days

PILOT: Number of subjects with a core lab-evaluated mitral regurgitation grade greater than or equal to moderate at 30-days

Outcome measures

Outcome measures
Measure	Transcatheter Mitral Valve Replacement (TMVR) Implant n=71 Participants Twelve TMVR Implant Twelve TMVR Implant: Implantation of the Twelve TMVR System -Apical Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System: Implant of Intrepid valve -Transfemoral
Number of Subjects With Greater Than or Equal Moderate (2+) Mitral Regurgitation at 30-days	0 Participants

Adverse Events

PILOT

Serious events: 93 serious events

Other events: 88 other events

Deaths: 62 deaths

Early Feasibility Study (EFS)

Serious events: 32 serious events

Other events: 33 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Additional Information

Yetunde Ishola (Clinical Study Manager)

Medtronic

Phone: 734-221-8182

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee According to the protocol, at the conclusion of the TMVR Pilot Study, a multi-center manuscript will be prepared for publication in a reputable scientific journal. The publication of the principal results from any single site experience within the study is not allowed until the preparation and publication of the multicenter results. Any follow-up publications would require prior written approval by the Publications Review Committee and the Sponsor.
Publication restrictions are in place

Restriction type: OTHER