Clinical trials: Aortic-Stenosis
Hypertrophic Cardiomyopathy
Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects
Mavacamten is a small-molecule allosteric inhibitor of cardiac myosin that reversibly inhibits its binding to cardiac actin, thereby relieving systolic hypercontractility and improving ventricular compliance.
- Trial name
- NCT05135871
- Testing
- Mavacamten
- Where
- China
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- LianBio LLC
Aortic Stenosis, Aortic Valve Stenosis
SAPIEN 3 Ultra EU PMS
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating…
- Trial name
- NCT04860752
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 37 sites in Austria, Finland and 8 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Symptomatic Hypertrophic Cardiomyopathy (HCM)
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
- Trial name
- FOREST-HCM (NCT04848506)
- Testing
- Aficamten (5 - 20 mg)
- Where
- 141 sites in United States, Argentina and 17 more
- Volunteers
- 900 people
- Sponsor
- Cytokinetics
Aortic Valve Stenosis
HLT Meridian Valve CE Mark Trial
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement…
- Trial name
- RADIANT CE (NCT03805711)
- Testing
- HLT® Transcatheter System
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- HLT Inc.
Severe Aortic Stenosis, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 people
- Sponsor
- Anteris Technologies Ltd.
Transcatheter Aortic Valve Implantation
Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis
The EMPIRE II study evaluates the safety and performance of the entire ALLEGRA THV System. The primary safety endpoint is composite of all-cause mortality or stroke rates at 12 months.
- Trial name
- EMPIRE-II (NCT05804903)
- Testing
- (ALLEGRA Plus Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 7 sites in Finland, Germany and 3 more
- Volunteers
- 177 people
- Sponsor
- NVT GmbH
Obstructive Hypertrophic Cardiomyopathy
A Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
The study is being conducted to evaluate the efficacy, and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy
- Trial name
- NCT06516068
- Testing
- HRS-1893
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
VOYAGER CE Clinical Study using the Encantor TAVI System.
- Trial name
- VOYAGER CE (NCT07696182)
- Testing
- Prospective, single-arm, multi-center study.
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Hypertrophic Cardiomyopathy (HCM), Obstructive HCM (oHCM)
Aom0304 in Adult Patients With Symptomatic Hypertrophic Cardiomyopathy
The goal of this clinical trial is designed to characterise the safety, tolerability, efficacy, and PK of Aom0304 across oHCM and nHCM populations and to inform dose selection for future Phase 3 development.
- Conditions
- Hypertrophic Cardiomyopathy (HCM), Obstructive HCM (oHCM), Non-obstructive HCM (nHCM)
- Trial name
- NCT07675668
- Testing
- QG101-23-0 enteric coated capsule (60/120/240/360 mg BID), QG101-23-0 enteric coated capsule (120/240/360/480mg BID)
- Volunteers
- 56 people
- Sponsor
- Amckaus PTY LTD.
Aortic Stenosis
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.
- Trial name
- NCT01876420
- Testing
- The CoreValve™ Evolut R TAV™ system
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Aortic Valve Stenosis
SAPIEN 3 Ultra System PMCF
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
- Trial name
- NCT04555967
- Testing
- SAPIEN 3 Ultra System
- Where
- 11 sites in Austria, Canada and 6 more
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Murmur, Heart, Aortic Valve Stenosis
Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes
The Eko CORE and DUO stethoscopes are FDA-approved electronic devices that have the capacity to record heart sounds. The study seeks to expand murmur detection to include VHD classification through the development of novel ML…
- Conditions
- Murmur, Heart, Aortic Valve Stenosis, Tricuspid Regurgitation, Mitral Regurgitation
- Trial name
- NCT04400513
- Testing
- Use of Eko CORE and Eko DUO electronic stethoscopes
- Where
- United States
- Volunteers
- 1,145 people
- Sponsor
- Eko Devices, Inc.
Aortic Valve Stenosis
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures.
- Trial name
- PostCorE (NCT02472106)
- Testing
- Post-dilatation
- Volunteers
- 9 people
- Sponsor
- InterValve, Inc.
Aortic Stenosis, Cardiomyopathy, Hypertrophic
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
- Trial name
- PII NR3/ViV (NCT03225001)
- Testing
- Edwards SAPIEN XT transcatheter valve, Model 9300TFX
- Where
- 47 sites in United States, Canada
- Volunteers
- 197 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Engager Direct Aortic Clinical Study
To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach.
- Trial name
- NCT01789567
- Testing
- Engager™ aortic valve
- Where
- 6 sites in Czechia, Germany and 1 more
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Disease, Aortic Valve Stenosis
PERCEVAL S Valve Clinical Study for Chinese Registration
This is a prospective, open, single arm, multi-center clinical study in China. The primary objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S heart valve when used to replace a diseased…
- Trial name
- PERFECT (NCT03481387)
- Testing
- Aortic Valve Replacement with Perceval S sutureless heart valve
- Where
- China
- Volunteers
- 61 people
- Sponsor
- Corcym S.r.l
Healthy Participants
A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.
- Trial name
- NCT05362045
- Testing
- Mavacamten
- Where
- 4 sites in United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Disease, Aortic Valve Stenosis
PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
Currently, warfarin is the only approved anticoagulation for patients with mechanical valves. The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained…
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Failure
- Trial name
- NCT04142658
- Testing
- Apixaban 5 MG, Apixaban 2.5 MG, Warfarin
- Where
- 62 sites in United States
- Volunteers
- 863 people
- Sponsor
- Artivion Inc.
Aortic Valve Disease, Aortic Stenosis
Sorin Universal REgistry on Aortic Valve Replacement
Multi-center, International, Prospective, Non comparative, Non randomized, Open label. 5,000 patients to be enrolled approximately worldwide.
- Trial name
- SURE-AVR (NCT02679404)
- Where
- 52 sites in United States, Australia and 15 more
- Volunteers
- 2,758 people
- Sponsor
- Corcym S.r.l