Clinical trials: Cardiac Valve Disease
Aortic Valve Stenosis
Valvuloplasty Scoring Balloon Catheter First-in-Man Study
The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of…
- Trial name
- NCT01514994
- Testing
- AngioScore's Valvuloplasty Scoring Balloon
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- Spectranetics Corporation
Severe Aortic Stenosis
SOURCE XT REGISTRY
This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that…
- Trial name
- NCT01238497
- Testing
- TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
- Where
- 104 sites in Austria, Belgium and 16 more
- Volunteers
- 2,954 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation (TR)
LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation
This clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd.
- Trial name
- NCT07705594
- Testing
- Transvenous Tricuspid Valve System implantation + OMT, OMT
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Jenscare Scientific
Aortic Stenosis
PERIGON Pivotal Trial
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
- Trial name
- PERIGON (NCT02088554)
- Testing
- Model 400 aortic valve bioprosthesis
- Where
- 38 sites in United States, Canada and 6 more
- Volunteers
- 1,312 people
- Sponsor
- Medtronic Cardiac Surgery
Severe Aortic Stenosis
HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA
The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.
- Trial name
- HORIZON CANADA (NCT02159794)
- Testing
- HLT Transcatheter Aortic Valve System
- Where
- Canada
- Sponsor
- HLT Inc.
Congenital Heart Defects, Dysfunctional Right Ventricular Outflow Tract Conduits
Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort
The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review.
- Trial name
- NCT00740870
- Testing
- Transcatheter Pulmonary Valve replacement
- Where
- 5 sites in United States
- Volunteers
- 171 people
- Sponsor
- Medtronic Cardiovascular
Obstructive Hypertrophic Cardiomyopathy
A Trial of HRS-1893 in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy
The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-1893 in healthy volunteers and patients with obstructive hypertrophic cardiomyopathy
- Trial name
- NCT05879523
- Testing
- HRS-1893
- Where
- China
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Cardiomegaly
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy
The purpose of the study is to determine whether the ability of MEK162 to antagonize MEK activation in NS HCM patients, who usually have upstream mutations in the Ras-Raf-Mek-Erk pathway that lead to MEK activation, would be…
- Trial name
- NCT01556568
- Testing
- MEK162
- Where
- 2 sites in United States, United Kingdom
- Sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
Aortic Stenosis, Symptomatic Aortic Stenosis
China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population
To evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are…
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation
- Trial name
- NCT03466918
- Testing
- SAPIEN 3 THV with the Commander delivery system
- Where
- 4 sites in China
- Volunteers
- 58 people
- Sponsor
- Edwards Lifesciences
Thromboembolism, Thrombosis
Tecarfarin Anti-Coagulation Trial (TACT)
TACT is a "real world" randomized controlled trial of tecarfarin, a novel vitamin K antagonist, vs. warfarin. The quality of anticoagulation control will be compared for the two groups of subjects who require chronic oral…
- Trial name
- TACT (NCT02522221)
- Testing
- Warfarin, tecarfarin
- Volunteers
- 1,000 people
- Sponsor
- Espero Biopharma
Aortic Insufficiency
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D…
- Trial name
- NCT01732835
- Testing
- HAART 300 Annuloplasty Device
- Where
- 8 sites in Czechia, Germany
- Volunteers
- 68 people
- Sponsor
- Biostable Science & Engineering
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - First In Human Israel
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- TWIST-FIHIL (NCT05688514)
- Testing
- Innovalve MR system
- Where
- Israel
- Volunteers
- 1 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease
Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study
The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic…
- Trial name
- SAPIEN3 (NCT01808287)
- Testing
- Edwards SAPIEN 3 Transcatheter Heart Valve
- Where
- 17 sites in Canada, France and 3 more
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy, Obstructive
REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy
This is a prospective, multicenter, randomized, parallel-controlled, superiority clinical trial designed to evaluate the efficacy and safety of a transcatheter intramyocardial septal radiofrequency ablation system for the…
- Trial name
- REFINE-HCM (NCT07006493)
- Testing
- Transcatheter Intramyocardial Septal Radiofrequency Ablation System
- Where
- 2 sites in China
- Volunteers
- 124 people
- Sponsor
- SuZhou Sinus Medical Technologies Co.,Ltd
Aortic Stenosis
PERIGON Japan Trial
The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.
- Trial name
- NCT02686814
- Testing
- 17mm MDT-2215 aortic valve bioprosthesis
- Where
- 10 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Medtronic Cardiac Surgery
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 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
Tricuspid Regurgitation, Heart Valve Diseases
The CLASP III TR CED Study
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the…
- Conditions
- Tricuspid Regurgitation, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT07859709
- Testing
- PASCAL Precision system Treated, Medicare Eligible Untreated Patients
- Where
- United States
- Volunteers
- 2,350 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
Effects of Rosuvastatin on Aortic Stenosis Progression
The purpose of this study is to assess the effects of rosuvastatin compared to usual care in patients diagnosed with aortic valvular stenosis.
- Trial name
- ASTRONOMER (NCT00800800)
- Testing
- Rosuvastatin
- Where
- 15 sites in Canada
- Volunteers
- 378 people
- Sponsor
- AstraZeneca
Hypertrophic Cardiomyopathy
A Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy
This study mainly evaluates the long-term safety of HRS-1893 in subjects with hypertrophic cardiomyopathy.
- Trial name
- NCT07021963
- Testing
- HRS-1893 Tablet
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.