Clinical trials: Heart Disease, Valvular
Aortic Valve Disease, Aortic Valve Stenosis
Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Heart Valve Diseases
- Trial name
- FAST TRACK (NCT05758909)
- Testing
- TF TAVI
- Where
- 13 sites in Spain
- Volunteers
- 585 people
- Sponsor
- Fundación EPIC
Shock, Aortic Valve Disease
Non-invasive Prediction of Fluid and Noradrenaline Responsiveness Using the Carotid Wave Intensity.
The goal of this observational study is to study a new method to compute ventricular-arterial coupling (VAC) in adult intensive care patients after cardiac surgery.
- Conditions
- Shock, Aortic Valve Disease, Coronary Artery Disease, Mitral Valve Disease
- Trial name
- VACC (NCT06197321)
- Where
- Netherlands
- Volunteers
- 120 people
- Sponsor
- Catharina Ziekenhuis Eindhoven
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
Pulmonary Hypertension, Valvular Heart Disease
Evaluating Right Ventricular (RV) Size and Function Using the Upper Valley RV Algorithm and Novel Imaging Modalities
The primary purpose of this study is to evaluate the diagnostic performance of three methods for measuring right ventricular size and function including the Philips Novel RV quantification technologies (RV Heart Model volumetric…
- Conditions
- Pulmonary Hypertension, Valvular Heart Disease, Congenital Heart Disease, Congestive Heart Failure
- Trial name
- UVRV (NCT03935178)
- Testing
- Measuring Right Ventricular Size and Function
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Aortic Stenosis
18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
This is a pilot study in which we will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve…
- Trial name
- NCT03095313
- Testing
- 18F-NaF
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cedars-Sinai Medical Center
Heart Disease
4 Cities for Assessing CAlcification PRognostic Impact After TAVI
Transcatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an alternative to conventional surgery for aortic stenosis cure.
- Trial name
- C4CAPRI (NCT02935491)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- France
- Volunteers
- 1,600 people
- Sponsor
- Hospices Civils de Lyon
Aortic Valve Stenosis
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic…
- Trial name
- PORTICO-IDE (NCT02000115)
- Testing
- Portico transcatheter aortic valve, Commercially available transcatheter aortic valve
- Where
- 70 sites in United States, Australia
- Volunteers
- 1,242 people
- Sponsor
- Abbott Medical Devices
Heart Valve Diseases, Moderate to Severe Valve Disease in the Elderly
China Elderly Valve Disease Study III (China-DVD3 Study)
This study aims to conduct a second round of multicenter, prospective registry research targeting elderly patients with valvular heart disease, to understand the current status of interventions for patients with valvular heart…
- Trial name
- NCT07816146
- Where
- China
- Volunteers
- 6,612 people
- Sponsor
- Yongjian Wu, MD, PhD
Mitral Valve Prolapse, Genetic Disease
Genetic and Phenotypic Characteristics of Mitral Valve Prolapse
Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP.
- Trial name
- MVP (NCT03884426)
- Where
- 3 sites in France
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Nantes University Hospital
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Ischemic And Bleeding Risk Assessment After TAVR
Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2).
- Trial name
- FOCUS ONE (NCT06000943)
- Testing
- Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT
- Where
- 12 sites in Belgium, Chile and 3 more
- Volunteers
- 2,500 people
- Sponsor
- Niguarda Hospital
Mitral Regurgitation, Mitral Valve Disease
AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation.
- Trial name
- AHEAD (NCT03339115)
- Testing
- Cardiovalve Transfemoral Mitral Valve
- Where
- 11 sites in Germany, Greece and 1 more
- Volunteers
- 30 people
- Sponsor
- Cardiovalve Ltd.
Aortic Stenosis, Non-rheumatic
Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure
To assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces serious complications due to the procedure, by decreasing the rate of vascular and hemorrhagic complications without increasing the rate of…
- Trial name
- HEPAVALV (NCT01823393)
- Testing
- Heparin, NaCl
- Where
- France
- Volunteers
- 94 people
- Sponsor
- University Hospital, Montpellier
Aortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation)
Cerebral Regional Oxygen Saturation During TAVI - The CROS-TAVI Prospective Registry
This single-center, non-commercial clinical study investigates how different types of transcatheter aortic valve prostheses affect cerebral oxygen saturation during the procedure (TAVI - Transcatheter Aortic Valve Implantation).
- Conditions
- Aortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation), Cerebral Oxygen Saturation, Hemodynamic Changes
- Trial name
- CROS-TAVI (NCT07016789)
- Testing
- Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Mitral Regurgitation
Cephea Early Feasibility Study
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral…
- Trial name
- NCT05061004
- Testing
- Cephea Mitral Valve System
- Where
- 22 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
A Study to Evaluate Effectiveness and Safety of Edoxaban in Patients 80 Years of Age or Older With Nonvalvular Atrial Fibrillation
Non-valvular atrial fibrillation (NVAF) increases the risk of stroke by three- to five-fold, especially in elderly patients, creating a huge burden on medical system as well as a negative impact on patients' lives.
- Trial name
- SILVERCARE_AF (NCT05804747)
- Testing
- Edoxaban
- Where
- 33 sites in South Korea
- Volunteers
- 1,204 people
- Sponsor
- Daiichi Sankyo
Hypertrophic Cardiomyopathy (HCM), Obstructive Hypertrophic Cardiomyopathy (oHCM)
Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy
This retrospective cohort study aims to evaluate the clinical efficacy and safety of mavacamten in adult patients with obstructive hypertrophic cardiomyopathy (oHCM).
- Trial name
- MAVA-HCM (NCT07529938)
- Testing
- mavacamten
- Where
- China
- Volunteers
- 222 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Valvular Heart Surgery
Prediction of Fluid Responsiveness in Atrial Fibrillation Patients Who Underwent Valvular Heart Surgery: Peep-induced Increase in Central Venous Pressure vs. Passive Leg Raising
Dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and cannot be applied to patients with atrial fibrillation.
- Trial name
- NCT02224378
- Testing
- peep induced CVP, passive leg raising(PLR)
- Where
- South Korea
- Volunteers
- 44 people
- Sponsor
- Yonsei University
Tricuspid Valve Regurgitation
MATTERS Study - 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
- NCT04071652
- Testing
- Mistral implantation
- Where
- 3 sites in Israel
- Volunteers
- 17 people
- Sponsor
- Mitralix
Aortic Valve Stenosis
Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation
Transcatheter aortic valve implantation (TAVI) has rapidly been adopted into clinical practice, but concerns have been raised regarding periprocedural complications like e.g. myocardial injury, stroke or acute kidney injury.
- Trial name
- NCT02080299
- Testing
- Remote ischemic preconditioning (RIPC)
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- University Hospital, Essen
Valvular Heart Disease
Pre-habilitation of Patients Scheduled for Cardiac Valve Surgery
Cardiac rehabilitation (CR) is an integral part of cardiovascular disease management incorporating aspects of scientifically constructed appropriate physical exercise.
- Trial name
- NCT03571906
- Testing
- Tele - Cardiac Pre-Rehabilitation
- Volunteers
- 25 people
- Sponsor
- Sheba Medical Center