Clinical trials: Valve
Cardiac Surgery With Cardiopulmonary Bypass, Valve Heart Disease
Transfusion in Cardiac Valve Surgery
This prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(CPB).
- Trial name
- TICVS (NCT06332547)
- Testing
- Restrictive Transfusion Strategy, Liberal Transfusion Strategy
- Where
- China
- Volunteers
- 1,600 people
- Sponsor
- Guangdong Provincial People's Hospital
Coronary Artery Bypass Grafting, Open Heart Surgery
Assessment of Platelet Function in Patients Undergoing Open Heart Surgery
The purpose of this external evaluation is to assess the system functionality and analytical performance of the Saturn Investigational Instrument (next generation VerifyNow instrument) and associated cartridge currently under…
- Conditions
- Coronary Artery Bypass Grafting, Open Heart Surgery, Aortic Surgery or Redo Surgery, On-pump Double or Triple Valve Procedures
- Trial name
- Saturn (NCT05441358)
- Testing
- Open Heart Surgery
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- LifeBridge Health
Structural Heart Abnormality, Valve Heart Disease
Capitalizing on AI to CapTure Undiagnosed Structural Heart Disease
Doctors are testing a new tool called EchoNext to see if it can help find heart problems earlier. EchoNext looks at the heart's electrical test, called an ECG, and uses artificial intelligence (AI) to check for signs of…
- Conditions
- Structural Heart Abnormality, Valve Heart Disease, Heart Diseases, Cardiovascular Diseases
- Trial name
- CACTUS (NCT07843004)
- Testing
- EHR Alert
- Where
- United States
- Volunteers
- 4,000 people
- Sponsor
- Pierre Elias
Aortic Valve Disease Mixed
Safety and Efficacy of Post-marketing Transcatheter Aortic Valves in "Real World" Chinese Patients
The purpose of this prospective multi-center, observational registry in China is to collect clinical baseline, procedural, and follow-up data of all patients treated with TAVR in China and to evaluate short-, mid-, and long-term…
- Trial name
- NCT06257043
- Testing
- Transcatheter aortic valve replacement
- Where
- China
- Volunteers
- 3,000 people
- Sponsor
- Xijing Hospital
Aortic Stenosis
SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI
Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with…
- Trial name
- SOLVE-TAVI (NCT02737150)
- Testing
- CoreValve Evolut R, Edwards Sapien 3, Local anesthesia with conscious sedation
- Where
- Germany
- Volunteers
- 444 people
- Sponsor
- Helios Health Institute GmbH
Osteoblast, Vascular Calcification
Use of Discarded Surgery Human Tissue Specimens for Basic Science Research
Although it is now established that calcification process result from the joint and coordinated action of different cell types, many areas of shadow remain regarding the spatio-temporal implementation of these events.
- Trial name
- HumTisRes (NCT04753593)
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Mitral Regurgitation
Multimodality Imaging Assessment of the Severity of Mitral Regurgitation
To investigate to assess the severity of mitral regurgitation by multimodality imaging.
- Trial name
- NCT06266858
- Testing
- rehydration, UCG, CMR
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Native and Valve in Valve Aortic Valve Failure
Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation
Background: TAVR is a common therapy for people with heart problems. It stands for transcatheter aortic valve replacement, TAVR can be a better option than surgery. But it isn t safe for everyone.
- Trial name
- BASILICA (NCT03381989)
- Testing
- ASHI_INTECC Astato XS 20 0.014 guidewire
- Where
- 4 sites in United States
- Volunteers
- 31 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Stenosis
Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
The primary purpose of this study is to observe reduced access site complications in patients with heavily calcified common femoral arteries requiring Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- NCT07205068
- Testing
- Shockwave M5 IVL Catheter, Modified Seldinger Technique
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Tennessee Graduate School of Medicine
Valve Disease, Aortic
ArcFlex Sheath in TAVR Trial
TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the…
- Trial name
- Arc-FIT (NCT07320274)
- Testing
- ArcFlex Sheath, ordinary sheath
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Sun Yat-sen University
Aortic Stenosis
Anatomical Determinants and Outcomes of Small Annulus Patients Undergoing TAVR in Different ASIAN Ethnicity
Transcatheter aortic valve implantation (TAVI) presents unique challenges for Asian patients compared to Caucasians, largely due to the prevalence of small aortic annulus (SAA) defined based on Caucasians' data (430 mm²)…
- Trial name
- NCT07240025
- Where
- Hong Kong
- Volunteers
- 31 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Aortic Stenosis, Gender
TAVI and Gender Outcomes Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation.
Severe aortic stenosis (AS) is the commonest form of valvular abnormality in the developed world and transcatheter aortic valve implantation (TAVI) is now widely practiced as in many cases is the preferred treatment option over…
- Conditions
- Aortic Stenosis, Gender, Surgery
- Trial name
- NCT04915976
- Volunteers
- 14,086 people, healthy volunteers welcome
- Sponsor
- Imperial College Healthcare NHS Trust
Mitral Valve (MV) Regurgitation
A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (DE)
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development.
- Trial name
- ACCESS-MR (DE) (NCT07757776)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Volunteers
- 20 people
- Sponsor
- Polares Medical SA
Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation
Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment…
- Conditions
- Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation, Right Ventricular Dysfunction
- Trial name
- LvL-PACE (NCT07534917)
- Testing
- Temporary left bundle branch area pacing, Temporary leadless right ventricular pacing
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Hypertrophic Cardiomyopathy, Hypertensive Heart Disease
Differentiation HHD From HCM (EARLY-MYO-HHD)
Differentiating hypertrophic cardiomyopathy (HCM) from hypertensive heart disease (HHD) unavoidably encounters diagnostic challenges especially in patient of suspected HCM with history of hypertension.
- Trial name
- NCT03271385
- Testing
- evaluated by the predetermined differentiating formula
- Where
- China
- Volunteers
- 465 people, healthy volunteers welcome
- Sponsor
- RenJi Hospital
Congenital Heart Diseases, Aortic Valve Disorder
Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients
The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will decrease the rate of cefazolin non-susceptible surgical site infections (SSI), in high risk population 2) to develop better understanding of…
- Trial name
- NCT01619982
- Testing
- Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride, Cefazolin 30 mg/kg body weight
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Stanford University
Tricuspid Regurgitation
Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation
This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral System for tricuspid valve replacement.
- Trial name
- NCT04100720
- Testing
- Cardiovalve Transfemoral Tricuspid Valve
- Where
- 3 sites in United States
- Sponsor
- Cardiovalve Ltd.
Tricuspid Regurgitation (TR)
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved…
- Trial name
- TREAT TR (NCT07586995)
- Testing
- Tricuspid Transcatheter Edge-to-Edge Repair (TEER)
- Where
- 9 sites in United States, Germany and 2 more
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Heart Failure With Reduced Ejection Fraction, Mitral Regurgitation
The CardioClip Study
The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin.
- Trial name
- CardioClip (NCT06241430)
- Testing
- CardioMEMS
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Columbia University
Microvascular Dysfunction, Hypertrophic Obstructive Cardiomyopathy
Association Between Microvascular Resistance and Outcomes in Patients With Obstructive Hypertrophic Cardiomyopathy
About 60% of patients with hypertrophic cardiomyopathy have microvascular dysfunction. Microvascular dysfunction is directly related to prognosis in hypertrophic cardiomyopathy.
- Conditions
- Microvascular Dysfunction, Hypertrophic Obstructive Cardiomyopathy, Microcirculation Resistance
- Trial name
- NCT05671367
- Where
- China
- Volunteers
- 340 people
- Sponsor
- China National Center for Cardiovascular Diseases
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