Clinical trials: Valvulopathy
Tricuspid Regurgitation
Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System
Evaluate the effectiveness and safety of the transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Medical Technology Co., Ltd.
- Trial name
- NCT05434507
- Testing
- Transcatheter Annuloplasty
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Shanghai Huihe Medical Technology Co., Ltd
Aortic Valve Stenosis
VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.
- Trial name
- NCT04414865
- Testing
- VitaFlow™ Transcatheter Aortic Valve System
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Mitral Valve Insufficiency
CG Future® Annuloplasty Ring/Band Clinical Trial
The primary goal of the study is to document the number of patients that are successfully implanted and benefit from the implantation of both a CG Future Annuloplasty ring or a band.
- Trial name
- NCT01074671
- Testing
- CG Future Annuloplasty Ring/Band
- Where
- 8 sites in Belgium, Germany and 3 more
- Volunteers
- 77 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Surgical Procedures, Coronary Artery Disease
Clinical Outcomes in Patients Treated With SternaLock Blu
The primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with SternaLock Blu for rigid sternal fixation.
- Conditions
- Cardiac Surgical Procedures, Coronary Artery Disease, Heart Valve Diseases
- Trial name
- SECURE (NCT03709693)
- Testing
- SternaLock Blu
- Where
- 4 sites in United States
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Mitral Valve Regurgitation
Tiara™ Transcatheter Mitral Valve Replacement Study
To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-II (NCT03039855)
- Testing
- TIARA valve and transapical delivery system
- Where
- 20 sites in Germany, Israel and 4 more
- Volunteers
- 157 people
- Sponsor
- Shockwave Medical, Inc.
Aortic Valve Stenosis
FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis
The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis.
- Trial name
- NCT05909748
- Testing
- GEMINUS Transcatheter Aortic Valve Implantation system
- Where
- 2 sites in Israel
- Volunteers
- 30 people
- Sponsor
- Valve Medical
Severe Mitral Valve Regurgitation, Severe Mitral Valve Stenosis
The Feasibility Study of Polymer Artificial Heart Valve for the Treatment the Mitral Valve Disease.
The study aims to evaluate the feasibility and safety of polymer artificial heart valve designed and developed by Shanghai HeartEpoch Medical technology Co. Ltd. for the treatment of the mitral valve diseases.
- Trial name
- HeartEpoch (NCT07243184)
- Testing
- mitral valve replacement
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Shanghai HeartEpoch Medical Technology Co., Ltd
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 Valve Stenosis, Aortic Valve Insufficiency
Clinical Investigation for the Foldax Tria Aortic Heart Valve- India
The purpose of this study is to conduct a clinical investigation of the Foldax Tria Aortic Valve to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Aortic Valve Calcification, Aortic Valve Disease
- Trial name
- NCT06192706
- Testing
- Foldax Tria Aortic Valve
- Where
- 10 sites in India
- Volunteers
- 50 people
- Sponsor
- Foldax, Inc
Heart Valve Disease
European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where ESPOIR pulmonary valve (PV) is prescribed in the usual manner in…
- Trial name
- ESPOIR (NCT02035540)
- Testing
- Decellularized human valves
- Where
- 8 sites in Belgium, France and 6 more
- Volunteers
- 121 people
- Sponsor
- corlife
Obstructive Hypertrophic Cardiomyopathy
An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM
This is an open-label extension study of China cohort in the phase 3 study (CY 6031) of aficamten for the treatment of obstructive HCM (oHCM) to collect long-term safety and tolerability data, including assessments of cardiac…
- Trial name
- NCT06116968
- Testing
- Aficamten
- Where
- 12 sites in China
- Volunteers
- 40 people
- Sponsor
- Corxel Pharmaceuticals
Functional Tricuspid Regurgitation, Heart Valve Diseases
Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with…
- Conditions
- Functional Tricuspid Regurgitation, Heart Valve Diseases, Tricuspid Valve Insufficiency
- Trial name
- NCT03632967
- Testing
- Tricinch Coil System Implantation
- Where
- 9 sites in United States
- Volunteers
- 7 people
- Sponsor
- 4Tech Cardio Ltd.
Danon Disease
Gene Therapy for Male Patients With Danon Disease (DD) Using RP-A501; AAV9.LAMP2B
This is a non-randomized open-label Phase 1 study to evaluate the safety and toxicity of gene therapy using a recombinant adeno-associated virus serotype 9 (AAV9) containing the human lysosome-associated membrane protein 2…
- Trial name
- NCT03882437
- Testing
- RP-A501
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Tricuspid Regurgitation
The TRICURE First in Human Trial
The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver…
- Trial name
- TRICURE (NCT05126030)
- Testing
- Topaz TTVR System
- Where
- 11 sites in Belgium, France
- Volunteers
- 20 people
- Sponsor
- TRiCares
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 Post-Approval Study
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT04860765
- Testing
- SAPIEN 3 THV
- Where
- 19 sites in United States
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Real-World Effectiveness of Mavacamten in Canada
The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM)…
- Trial name
- MAVEN (NCT06338202)
- Testing
- Mavacamten
- Where
- Canada
- Volunteers
- 115 people
- Sponsor
- Bristol-Myers Squibb
Aortic Stenosis
SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice
This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.
- Trial name
- SOURCE 3 (NCT02698956)
- Testing
- TAVI (Transcatheter Aortic Valve Implantation)
- Where
- 73 sites in Denmark, Finland and 8 more
- Volunteers
- 2,000 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Aortic Regurgitation
Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease
To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and…
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Hypertension, LVM
- Trial name
- NCT03666351
- Testing
- Amlodipine 5mg, Losartan, Losartan and Amlodipine
- Where
- South Korea
- Volunteers
- 128 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Perceval S Aortic Heart Valve Study- North America
To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- NCT01810679
- Testing
- Perceval S Aortic Heart Valve
- Where
- 21 sites in United States
- Volunteers
- 355 people
- Sponsor
- Sorin Group USA, Inc.