Mitral Valve Insufficiency

Pipeline Programs

Companies

Clinical Trials

1 recruiting

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule

2100%

+ 21 programs with unclassified modality

Competitive Landscape

10 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

MedtronicNJ - Phillipsburg

3 programs

CG Future Annuloplasty Ring/BandPhase 41 trial

TMVR ImplantN/A1 trial

Twelve TMVR ImplantN/A1 trial

Active Trials

NCT02428010Terminated3Est. Apr 2021

NCT02322840Active Not Recruiting128Est. Dec 2028

NCT01074671Completed77Est. Sep 2011

SandozAustria - Kundl

1 program

LCZ696Phase 41 trial

Active Trials

NCT02687932Completed118Est. Jan 2018

MSDIreland - Ballydine

1 program

ErtugliflozinPhase 3Small Molecule

Sharp TherapeuticsPA - Pittsburgh

1 program

ErtugliflozinPhase 3Small Molecule1 trial

Active Trials

NCT04231331Completed128Est. Nov 2023

AbbottABBOTT PARK, IL

6 programs

Percutaneous mitral valve repairPhase 1/21 trial

Degenerative Mitral Regurgitation in Intermediate Risk PatientsN/A1 trial

MitraClip® implantN/A1 trial

Percutaneous mitral valve repair using MitraClip implantN/A1 trial

+1 more programs

Active Trials

NCT02604745Completed13Est. Jan 2021

NCT01931956Completed965Est. Jun 2018

NCT00209274Completed279Est. Dec 2014

+3 more trials

Edwards LifesciencesCA - Irvine

5 programs

Adjustable Annuloplasty Ring with option to adjust off pump.N/A1 trial

CardiobandN/A1 trial

Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian PopulationN/A1 trial

Edwards PASCAL Transcatheter Valve Repair SystemN/A1 trial

Edwards SAPIEN 3 transcatheter valve, Model 9600TFXN/A1 trial

Active Trials

NCT01137734Completed30Est. Jan 2014

NCT02703311Terminated11Est. Dec 2018

NCT06757049Recruiting200Est. Mar 2031

+2 more trials

NeoChordMN - Maple Grove

3 programs

NeoChord DS1000N/A1 trial

NeoChord TACT Post-Market Surveillance RegistryN/A1 trial

NeoChord Transcatheter Mitral Repair SystemN/A1 trial

Active Trials

NCT02803957Active Not Recruiting585Est. Jan 2027

NCT01784055Completed126Est. Jul 2016

NCT05425628Unknown30Est. Dec 2023

Cardiac DimensionsAustralia - Sydney

1 program

Carillon Mitral Contour SystemN/A1 trial

Active Trials

NCT02325830Completed163Est. Jan 2020

Boston ScientificCA - Valencia

1 program

Mitral Valve IRIS RingN/A1 trial

Active Trials

NCT02607527Completed21Est. Dec 2019

Rhythm PharmaceuticalsBOSTON, MA

1 program

CG Future Annuloplasty Ring/BandPHASE_4

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

2027

2028

2029

2030

2031

SandozLCZ696

MedtronicCG Future Annuloplasty Ring/Band

Sharp TherapeuticsErtugliflozin

AbbottPercutaneous mitral valve repair

Edwards LifesciencesClinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population

NeoChordNeoChord Transcatheter Mitral Repair System

Edwards LifesciencesEdwards PASCAL Transcatheter Valve Repair System

Edwards LifesciencesEdwards SAPIEN 3 transcatheter valve, Model 9600TFX

Boston ScientificMitral Valve IRIS Ring

NeoChordNeoChord DS1000

Edwards LifesciencesCardioband

AbbottDegenerative Mitral Regurgitation in Intermediate Risk Patients

Cardiac DimensionsCarillon Mitral Contour System

MedtronicTwelve TMVR Implant

MedtronicTMVR Implant

Showing 15 of 21 trials with date data

Clinical Trials (21)

Total enrollment: 3,463 patients across 21 trials

NCT02687932 SandozLCZ696

Pharmacological Reduction of Functional, Ischemic Mitral REgurgitation

Start: Mar 2016Est. completion: Jan 2018118 patients

Phase 4Completed

NCT01074671 MedtronicCG Future Annuloplasty Ring/Band

CG Future® Annuloplasty Ring/Band Clinical Trial

Start: Jun 2009Est. completion: Sep 201177 patients

Phase 4Completed

NCT04231331 Sharp TherapeuticsErtugliflozin

Ertugliflozin for Functional Mitral Regurgitation

Start: Nov 2020Est. completion: Nov 2023128 patients

Phase 3Completed

NCT00209339 AbbottPercutaneous mitral valve repair

Feasibility Study of a Percutaneous Mitral Valve Repair System.

Start: Jul 2003Est. completion: Oct 201155 patients

Phase 1/2Completed

NCT06757049 Edwards LifesciencesClinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population

Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population

Start: Dec 2024Est. completion: Mar 2031200 patients

N/ARecruiting

NCT05425628 NeoChordNeoChord Transcatheter Mitral Repair System

European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation

Start: Aug 2022Est. completion: Dec 202330 patients

N/AUnknown

NCT04443218 Edwards LifesciencesEdwards PASCAL Transcatheter Valve Repair System

Edwards PASCAL Transcatheter Valve Repair System Registry

Start: May 2019Est. completion: May 2021220 patients

N/ACompleted

NCT03193801 Edwards LifesciencesEdwards SAPIEN 3 transcatheter valve, Model 9600TFX

PARTNER 3 Trial - Mitral Valve in Valve

Start: Feb 2018Est. completion: Aug 203153 patients

N/AActive Not Recruiting

NCT02607527 Boston ScientificMitral Valve IRIS Ring

Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System

Start: May 2017Est. completion: Dec 201921 patients

N/ACompleted

NCT02803957 NeoChordNeoChord DS1000

Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

Start: Nov 2016Est. completion: Jan 2027585 patients

N/AActive Not Recruiting

NCT02703311 Edwards LifesciencesCardioband

REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System

Start: Aug 2016Est. completion: Dec 201811 patients

N/ATerminated

NCT02604745 AbbottDegenerative Mitral Regurgitation in Intermediate Risk Patients

Degenerative Mitral Regurgitation in Intermediate Risk Patients

Start: Mar 2016Est. completion: Jan 202113 patients

N/ACompleted

NCT02325830 Cardiac DimensionsCarillon Mitral Contour System

Carillon Mitral Contour System® for Reducing Functional Mitral Regurgitation

Start: Aug 2015Est. completion: Jan 2020163 patients

N/ACompleted

NCT02322840 MedtronicTwelve TMVR Implant

Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System

Start: Apr 2015Est. completion: Dec 2028128 patients

N/AActive Not Recruiting

NCT02428010 MedtronicTMVR Implant

Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

Start: Sep 2014Est. completion: Apr 20213 patients

N/ATerminated

NCT01784055 NeoChordNeoChord TACT Post-Market Surveillance Registry

NeoChord TACT Post-Market Surveillance Registry

Start: Mar 2013Est. completion: Jul 2016126 patients

N/ACompleted

NCT01137734 Edwards LifesciencesAdjustable Annuloplasty Ring with option to adjust off pump.

CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

Start: Mar 2010Est. completion: Jan 201430 patients

N/ACompleted

NCT01931956 AbbottMitraClip® implant

Real World Expanded Multicenter Study of the MitraClip® System (REALISM)

Start: Jan 2009Est. completion: Jun 2018965 patients

N/ACompleted

NCT00727012 Abbottmitral valve repair

Multicenter International Trial Ring AnnulopLasty

Start: Jun 2008Est. completion: Nov 2010180 patients

N/ACompleted

NCT01940120 AbbottPercutaneous mitral valve repair using MitraClip implant

EVEREST II Pivotal Study High Risk Registry (HRR)

Start: Feb 2007Est. completion: Feb 201378 patients

N/ACompleted

NCT00209274 AbbottPercutaneous mitral valve repair using MitraClip implant

Pivotal Study of a Percutaneous Mitral Valve Repair System

Start: Aug 2005Est. completion: Dec 2014279 patients

N/ACompleted

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals

1 actively recruiting trials targeting 3,463 patients

10 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.