Mitral Valve Regurgitation

Pipeline Programs

Companies

Clinical Trials

3 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

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

ViiV HealthcareNC - Durham

1 program

Lovaza groupPhase 4

Edwards LifesciencesCA - Irvine

7 programs

Transcatheter Mitral Valve Re-placementPhase 1/21 trial

3 dimensional echocardiographyN/A1 trial

Harpoon Artificial ePTFE ChordsN/A1 trial

Harpoon Medical DeviceN/A1 trial

+2 more programs

Active Trials

NCT00428103Withdrawn0Est. Dec 2012

NCT03285724Terminated1Est. Apr 2018

NCT02768870Completed26Est. Sep 2022

+4 more trials

AbbottABBOTT PARK, IL

7 programs

Adjustable Annuloplasty RingN/A1 trial

GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4N/A1 trial

MitraClip G4 SystemN/A1 trial

MitraClip NTR/XTR SystemN/A1 trial

MitraClip™ device implantationN/A1 trial

+2 more programs

Active Trials

NCT00554151Completed55Est. Apr 2010

NCT05455489Recruiting264Est. Aug 2029

NCT04177394Active Not Recruiting1,164Est. Mar 2028

+4 more trials

Affluent MedicalFrance - AIX-EN-PROVENCE

3 programs

Epygon™ Transcatheter Mitral Valve SystemN/A1 trial

Kalios ImplantN/A1 trial

Kephalios Device 1N/A1 trial

Active Trials

NCT04775108Recruiting40Est. Dec 2029

NCT03908983Unknown100Est. May 2025

NCT03842397Completed5Est. Nov 2018

Shockwave MedicalCA - Santa Clara

2 programs

Mitral valve replacementN/A1 trial

TIARA valve and transapical delivery systemN/A1 trial

Active Trials

NCT02276547Active Not Recruiting27Est. Aug 2025

NCT03039855Completed157Est. Aug 2024

MedtronicNJ - Phillipsburg

1 program

Medtronic Intrepid Transcatheter Mitral Valve Replacement SystemN/A1 trial

Active Trials

NCT03242642Recruiting1,056Est. Sep 2036

NeoChordMN - Maple Grove

1 program

NeoChord DS1000 Artificial Chordae Delivery SystemN/A1 trial

Active Trials

NCT01777815Completed30Est. Aug 2014

GSKLONDON, United Kingdom

1 program

Lovaza groupPHASE_41 trial

Active Trials

NCT01046604Unknown24Est. Dec 2013

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

2027

2028

2029

2030

2031

GSKLovaza group

Edwards LifesciencesTranscatheter Mitral Valve Re-placement

AbbottGISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4

AbbottTendyne™ Mitral Valve System

Affluent MedicalEpygon™ Transcatheter Mitral Valve System

AbbottMitraClip™ device implantation

AbbottMitraClip G4 System

Affluent MedicalKalios Implant

AbbottMitraClip NTR/XTR System

Affluent MedicalKephalios Device 1

MedtronicMedtronic Intrepid Transcatheter Mitral Valve Replacement System

Edwards LifesciencesMitral Valve Repair

Edwards LifesciencesHarpoon Artificial ePTFE Chords

Shockwave MedicalTIARA valve and transapical delivery system

Edwards LifesciencesHarpoon Artificial ePTFE Chords

Showing 15 of 22 trials with date data

Clinical Trials (22)

Total enrollment: 5,044 patients across 22 trials

NCT01046604 GSKLovaza group

Pilot Study of Lovaza (Omega 3 Fatty Acids) to Improve Cardiac Antioxidant/Anti-inflammatory Profile Before Cardiac Surgery

Start: Jan 2010Est. completion: Dec 201324 patients

Phase 4Unknown

NCT02722551 Edwards LifesciencesTranscatheter Mitral Valve Re-placement

CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study

Start: Nov 2016Est. completion: Oct 20240

Phase 1/2Withdrawn

NCT05455489 AbbottGISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4

GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4

Start: Jan 2023Est. completion: Aug 2029264 patients

N/ARecruiting

NCT04818502 AbbottTendyne™ Mitral Valve System

Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation

Start: May 2021Est. completion: May 2029200 patients

N/AActive Not Recruiting

NCT04775108 Affluent MedicalEpygon™ Transcatheter Mitral Valve System

First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System

Start: Feb 2021Est. completion: Dec 202940 patients

N/ARecruiting

NCT04198870 AbbottMitraClip™ device implantation

MitraClip REPAIR MR Study

Start: Jul 2020Est. completion: Dec 2035500 patients

N/AActive Not Recruiting

NCT04177394 AbbottMitraClip G4 System

MitraClip EXPAND G4 Study

Start: Jan 2020Est. completion: Mar 20281,164 patients

N/AActive Not Recruiting

NCT03908983 Affluent MedicalKalios Implant

OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation

Start: Nov 2019Est. completion: May 2025100 patients

N/AUnknown

NCT03502811 AbbottMitraClip NTR/XTR System

The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices

Start: Apr 2018Est. completion: Dec 20201,041 patients

N/ACompleted

NCT03842397 Affluent MedicalKephalios Device 1

OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation

Start: Dec 2017Est. completion: Nov 20185 patients

N/ACompleted

NCT03242642 MedtronicMedtronic Intrepid Transcatheter Mitral Valve Replacement System

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

Start: Oct 2017Est. completion: Sep 20361,056 patients

N/ARecruiting

NCT03170349 Edwards LifesciencesMitral Valve Repair

The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

Start: Jun 2017Est. completion: May 2025124 patients

N/ACompleted

NCT03285724 Edwards LifesciencesHarpoon Artificial ePTFE Chords

Safety and Performance Study of the Harpoon Mitral Valve Repair System

Start: May 2017Est. completion: Apr 20181 patients

N/ATerminated

NCT03039855 Shockwave MedicalTIARA valve and transapical delivery system

Tiara™ Transcatheter Mitral Valve Replacement Study

Start: Mar 2017Est. completion: Aug 2024157 patients

N/ACompleted

NCT02768870 Edwards LifesciencesHarpoon Artificial ePTFE Chords

CE Mark Study for the Harpoon Medical Device

Start: Apr 2016Est. completion: Sep 202226 patients

N/ACompleted

NCT02432196 Edwards LifesciencesHarpoon Medical Device

CE Mark Study for the Harpoon Medical Device in Poland

Start: Dec 2015Est. completion: Nov 202226 patients

N/ACompleted

NCT02771275 Edwards LifesciencesHarpoon Medical Device

Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)

Start: Feb 2015Est. completion: Jul 202113 patients

N/ACompleted

NCT02276547 Shockwave MedicalMitral valve replacement

Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System

Start: Dec 2014Est. completion: Aug 202527 patients

N/AActive Not Recruiting

NCT02321514 AbbottTendyne Mitral Valve System

Expanded Clinical Study of the Tendyne Mitral Valve System

Start: Nov 2014Est. completion: Apr 2025191 patients

N/ACompleted

NCT01777815 NeoChordNeoChord DS1000 Artificial Chordae Delivery System

Safety and Performance Study of the NeoChord Device

Start: Oct 2009Est. completion: Aug 201430 patients

N/ACompleted

NCT00554151 AbbottAdjustable Annuloplasty Ring

Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study

Start: Jul 2007Est. completion: Apr 201055 patients

N/ACompleted

NCT00428103 Edwards Lifesciences3 dimensional echocardiography

Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy

Start: Oct 2006Est. completion: Dec 20120

N/AWithdrawn

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

3 actively recruiting trials targeting 5,044 patients

8 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.