Clinical trials: Cardiac Valve Disease
Aortic Valve Stenosis, Aortic Valve Calcification
REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm
This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Disease
- Trial name
- REPRISE I (NCT01383720)
- Testing
- Lotus Valve System
- Where
- 3 sites in Australia
- Volunteers
- 11 people
- Sponsor
- Boston Scientific Corporation
Aortic Stenosis
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
To observe and evaluate the safety and efficacy of TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance…
- Trial name
- NCT04815785
- Testing
- TaurusOne® transcatheter aortic valve replacement system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Aortic Valve Stenosis
Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-man
- Trial name
- NCT03779620
- Testing
- Ultrasound treatment of Calcified aortic valve
- Where
- 2 sites in France, Netherlands
- Volunteers
- 30 people
- Sponsor
- Cardiawave SA
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
Tricuspid Valve Regurgitation
MATTERS II - Mistral Percutaneous Tricuspid Valve Repair FIM Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
- Trial name
- NCT04073979
- Testing
- Mistral implantation
- Where
- 4 sites in Germany
- Volunteers
- 9 people
- Sponsor
- Mitralix
Heart Valve Disease
Prospective Randomized On-X Versus SJM Evaluation Trial
The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.
- Trial name
- PROSE (NCT00639782)
- Testing
- On-X Heart valve replacement, SJM Heart valve replacement
- Where
- 28 sites in United States, Australia and 7 more
- Volunteers
- 857 people
- Sponsor
- On-X Life Technologies, Inc.
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
Mitral Regurgitation
Cardiovalve Transfemoral System - FIM Study
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
- Trial name
- NCT03958773
- Testing
- Cardiovalve transfemoral Mitral valve system
- Where
- Lithuania
- Volunteers
- 10 people
- Sponsor
- Cardiovalve Ltd.
Intensive Care Unit, Coronary Artery Bypass Grafting (CABG)
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy. A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight…
- Conditions
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass
- Trial name
- MODIFY CSX (NCT06279793)
- Testing
- Fish Oil, Intravenous 0.9% Sodium Chloride
- Where
- 10 sites in Germany
- Volunteers
- 550 people
- Sponsor
- GCP-Service International West GmbH
Atrial Fibrillation (AF), Mitral Valve (MV) Regurgitation
EPX-HTG for Structural Heart Procedures
To investigate and evaluate the benefits of adding EchoPixel Holographic Therapy Guidance to the current standard of care in Structural Heart (SH) procedures.
- Trial name
- EPX-HTG-2026 (NCT07705425)
- Testing
- Left Atrial Appendage Occlusion, Mitral Valve Transcatheter Edge to Edge Repair
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- EchoPixel, Inc.
Aortic Valve Stenosis, Aortic Valve Insufficiency
Enable I Long-term Follow-up Study
This was a prospective, non-randomized, multi-center, non-interventional post-market study. The study was a post-market long-term follow-up study based on the same cohort of patients (148 patients) enrolled in a previous…
- Trial name
- NCT01636648
- Testing
- Aortic Valve Replacement
- Where
- 6 sites in Germany, Poland and 1 more
- Volunteers
- 42 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Mitral Valve Regurgitation (Degenerative or Functional)
Edwards EVOQUE Eos MISCEND Study
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system
- Trial name
- NCT02718001
- Testing
- Edwards EVOQUE Eos Mitral Valve Replacement System
- Where
- 19 sites in United States, Canada
- Volunteers
- 123 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Transfemoral Implant of Inovare® Transcatheter Valve
Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.
- Trial name
- NCT05531578
- Testing
- INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)
- Where
- 4 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Valvular Heart Disease, Aortic Valve Disease
Regent China Post-Market Clinical Follow-up Study
Regent China Post-Market Clinical Follow-Up (RC-PMCF): this clinical study is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population.
- Trial name
- NCT05330468
- Testing
- Abbott Mechanical Heart Valve (MHV) Regent™
- Where
- 5 sites in China
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Bypass Grafting, Mitral Valve Surgery
Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced…
- Conditions
- Coronary Artery Bypass Grafting, Mitral Valve Surgery, Low Cardiac Output Syndrome
- Trial name
- LEVO-CTS (NCT02025621)
- Testing
- Levosimendan
- Where
- 60 sites in United States, Canada
- Volunteers
- 882 people
- Sponsor
- Tenax Therapeutics, Inc.
Hypertrophic Cardiomyopathy, Obstructive Hypertrophic Cardiomyopathy
A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM
Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study.
- Conditions
- Hypertrophic Cardiomyopathy, Obstructive Hypertrophic Cardiomyopathy, Non-obstructive Hypertrophic Cardiomyopathy
- Trial name
- NCT03723655
- Testing
- mavacamten
- Where
- 68 sites in United States, Belgium and 11 more
- Volunteers
- 314 people
- Sponsor
- Bristol-Myers Squibb
Hypertrophic Cardiomyopathy With Obstruction
Triple Chamber Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients - TRICHAMPION STUDY
This investigation is a prospective, randomized, single-blinded and multicenter design. The purpose of this study is to evaluate the benefit of atrial-synchronous biventricular (BiV) pacing in severely symptomatic hypertrophic…
- Trial name
- TRICHAMPION (NCT01614717)
- Testing
- CRT-P Implant
- Where
- Spain
- Volunteers
- 25 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation
SQ-Kyrin-T First-in-man Feasibility Study
The goal of this clinical trial is to evaluate the performance, operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with…
- Trial name
- NCT06605313
- Testing
- SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Aortic Valve Stenosis
FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.
- Trial name
- NCT03417011
- Testing
- Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)
- Where
- 39 sites in Austria, Belgium and 12 more
- Volunteers
- 638 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Disease
Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population
The objective of the study is to evaluate the safety information on the Perceval S sutureless prosthetic heart valve after the implantation for aortic valve disease.
- Trial name
- NCT06011148
- Testing
- Perceval S sutureless heart valve
- Volunteers
- 80 people
- Sponsor
- Corcym S.r.l