Aortic Valve Stenosis

Cardiovascular
4
Pipeline Programs
10
Companies
26
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
1
3
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

U
EDOXABANApproved
edoxaban
Unknown Company
oral

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Abbott
AbbottABBOTT PARK, IL
7 programs
1
Tissue valvePhase 41 trial
Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral N/A1 trial
Portico transcatheter aortic valveN/A1 trial
St Jude Medical Portico replacement aortic valveN/A1 trial
Transaortic TAVR ImplantN/A1 trial
+2 more programs
Active Trials
NCT01497418Completed2Est. Mar 2014
NCT02000115Active Not Recruiting1,242Est. Dec 2026
NCT01802788Completed1,032Est. Oct 2022
+5 more trials
DS
Daiichi SankyoChina - Shanghai
2 programs
1
1
NOACPhase 41 trial
EdoxabanPhase 31 trial
Active Trials
NCT04171726Unknown100Est. Sep 2023
NCT03284827Completed235Est. Nov 2021
Rhythm Pharmaceuticals
8 programs
Aortic Valve ReplacementN/A1 trial
CoreValve Advance-II Study: Prospective International Post-market StudyN/A1 trial
CoreValve Transcatheter ValveN/A1 trial
Engager Transcatheter Aortic Valve Implantation SystemN/A1 trial
Engager™ aortic valveN/A1 trial
+3 more programs
Active Trials
NCT01636648Terminated42Est. Apr 2016
NCT01624870Completed200Est. Mar 2014
NCT02209298Completed202Est. Dec 2018
+5 more trials
JenaValve
JenaValveCA - Irvine
3 programs
JenaValve Pericardial TAVR SystemN/A1 trial
JenaValve Pericardial TAVR SystemN/A1 trial
Transcatheter Aortic Valve ImplantationN/A1 trial
Active Trials
NCT02732691UnknownEst. Apr 2024
NCT02818959TerminatedEst. May 2015
NCT05536310Not Yet RecruitingEst. Oct 2027
Eko Devices
Eko DevicesCA - Emeryville
1 program
AS Algorithm 1N/A1 trial
Active Trials
NCT03458806Completed156Est. Nov 2019
Verona Pharma
Verona PharmaUK - London
1 program
Aortic valve replacementN/A1 trial
Active Trials
NCT03143361RecruitingEst. Oct 2029
Tempus
TempusIL - Chicago
1 program
Automated alertN/A1 trial
Active Trials
NCT06099665Completed2,118Est. Dec 2025
Siemens Healthineers
Siemens HealthineersGermany - Forchheim
1 program
CT-ADP performed during TAVI procedureN/A1 trial
Active Trials
NCT03728049UnknownEst. Dec 2025
Foldax
FoldaxUT - Salt Lake City
1 program
Foldax Tria Aortic ValveN/A1 trial
Active Trials
NCT06192706UnknownEst. Sep 2024

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Daiichi SankyoNOAC
AbbottTissue valve
Daiichi SankyoEdoxaban
TempusAutomated alert
JenaValveTranscatheter Aortic Valve Implantation
AbbottTranscatheter Aortic Valve Replacement
FoldaxFoldax Tria Aortic Valve
AbbottTranscatheter Aortic Valve Replacement
Siemens HealthineersCT-ADP performed during TAVI procedure
Eko DevicesAS Algorithm 1
Verona PharmaAortic valve replacement
AbbottTransaortic TAVR Implant
JenaValveJenaValve Pericardial TAVR System
AbbottTranscatheter aortic valve replacement
Rhythm PharmaceuticalsCoreValve Transcatheter Valve

Showing 15 of 26 trials with date data

Clinical Trials (26)

Total enrollment: 6,336 patients across 26 trials

NCT03284827Daiichi SankyoNOAC

Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement

Start: Mar 2018Est. completion: Nov 2021235 patients
Phase 4Completed
NCT00256165AbbottTissue valve

REST Study: Left Ventricular Regression European Study

Start: Jan 2006Est. completion: Jul 2008150 patients
Phase 4Completed
NCT04171726Daiichi SankyoEdoxaban

Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation

Start: Aug 2019Est. completion: Sep 2023100 patients
Phase 3Unknown
NCT06099665TempusAutomated alert

Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform

Start: Aug 2024Est. completion: Dec 20252,118 patients
N/ACompleted
NCT05536310JenaValveTranscatheter Aortic Valve Implantation

TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease

Start: Mar 2023Est. completion: Oct 2027
N/ANot Yet Recruiting
NCT05171712AbbottTranscatheter Aortic Valve Replacement

Portico and Navitor India Clinical Trial

Start: May 2022Est. completion: Jan 202530 patients
N/ACompleted
NCT06192706FoldaxFoldax Tria Aortic Valve

Clinical Investigation for the Foldax Tria Aortic Heart Valve- India

Start: Jan 2022Est. completion: Sep 2024
N/AUnknown
NCT05002088AbbottTranscatheter Aortic Valve Replacement

Portico Valve-in-Valve Retrospective Registry

Start: Oct 2021Est. completion: Dec 202371 patients
N/ACompleted
NCT03728049Siemens HealthineersCT-ADP performed during TAVI procedure

Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes

Start: Dec 2019Est. completion: Dec 2025
N/AUnknown
NCT03458806Eko DevicesAS Algorithm 1

Phono- and Electrocardiogram Assisted Detection of Valvular Disease

Start: Feb 2018Est. completion: Nov 2019156 patients
N/ACompleted
NCT03143361Verona PharmaAortic valve replacement

Prospective European Multicenter Study on Aortic Valve Replacement: (E-AVR Registry)

Start: Nov 2017Est. completion: Oct 2029
N/ARecruiting
NCT03056573AbbottTransaortic TAVR Implant

Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access

Start: Mar 2017Est. completion: Jul 201964 patients
N/ACompleted
NCT02732691JenaValveJenaValve Pericardial TAVR System

JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

Start: Oct 2016Est. completion: Apr 2024
N/AUnknown
NCT02825134AbbottTranscatheter aortic valve replacement

Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis

Start: Jun 2016Est. completion: Jun 2029376 patients
N/AActive Not Recruiting
NCT02209298Rhythm PharmaceuticalsCoreValve Transcatheter Valve

CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.

Start: Nov 2014Est. completion: Dec 2018202 patients
N/ACompleted
NCT02149654Rhythm PharmaceuticalsEngager Transcatheter Aortic Valve Implantation System

Engager Align Post-market Clinical Study

Start: May 2014Est. completion: Jan 201727 patients
N/ACompleted
NCT02000115AbbottPortico transcatheter aortic valve

Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

Start: May 2014Est. completion: Dec 20261,242 patients
N/AActive Not Recruiting
NCT02818959JenaValveJenaValve Pericardial TAVR System

First in Man Study of the JenaValve TAVI Plus System Transfemoral

Start: Dec 2013Est. completion: May 2015
N/ATerminated
NCT01789567Rhythm PharmaceuticalsEngager™ aortic valve

Engager Direct Aortic Clinical Study

Start: May 2013Est. completion: Jun 201520 patients
N/ACompleted
NCT01802788AbbottSt Jude Medical Portico replacement aortic valve

5 Year Observation of Patients With PORTICO Valves

Start: Apr 2013Est. completion: Oct 20221,032 patients
N/ACompleted
NCT01636648Rhythm PharmaceuticalsAortic Valve Replacement

Enable I Long-term Follow-up Study

Start: Aug 2012Est. completion: Apr 201642 patients
N/ATerminated
NCT01497418AbbottLong Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral

Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System

Start: Dec 2011Est. completion: Mar 20142 patients
N/ACompleted
NCT01624870Rhythm PharmaceuticalsCoreValve Advance-II Study: Prospective International Post-market Study

CoreValve Advance-II Study: Prospective International Post-market Study

Start: Oct 2011Est. completion: Mar 2014200 patients
N/ACompleted
NCT01348438Rhythm PharmaceuticalsMedtronic Engager Transcatheter Aortic Valve Implantation System

Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial

Start: Sep 2011Est. completion: Jan 2018125 patients
N/ACompleted
NCT01051310Rhythm PharmaceuticalsMedtronic CoreValve System

Medtronic CoreValve REDO Study

Start: Jun 2008Est. completion: Jan 201118 patients
N/ACompleted
NCT01051518Rhythm PharmaceuticalsMedtronic CoreValve System

Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)

Start: May 2006Est. completion: Jun 2013126 patients
N/ACompleted

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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

1 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 6,336 patients
10 companies competing in this space

Related Indications

Heart Failure(334)Hypertension(333)Coronary Artery Disease(295)Atrial Fibrillation(288)Pulmonary Arterial Hypertension(103)Acute Coronary Syndrome(62)Pulmonary Hypertension(55)Essential Hypertension(32)Coronary Heart Disease(28)Atherosclerosis(27)