Clinical trials: Valve
Aortic Stenosis
PRospective Evaluation Complementing Investigation With Acurate Neo Device
The study collects real-world data of patients who were treated with the Acurate Neo TAVI System and evaluates early and midterm clinical outcomes.
- Trial name
- PRECISA (NCT03846557)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 10 sites in Spain
- Volunteers
- 300 people
- Sponsor
- Fundación EPIC
Coronary Disease, Mitral Valve Insufficiency
Should we Repair Ischemic Mitral Regurgitation?
The purpose of this study is to assess whether adding mitral valve repair to coronary artery bypass grafting improves outcome in patients with ischemic mitral regurgitation.
- Trial name
- NCT00443365
- Testing
- Mitral valve repair
- Where
- Poland
- Volunteers
- 100 people
- Sponsor
- Medical University of Silesia
Valvular Heart Disease
Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve
This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.
- Trial name
- EPIC (NCT00329667)
- Testing
- EPIC
- Volunteers
- 761 people
- Sponsor
- Abbott Medical Devices
Right Ventricular Outflow Tract Absent, Congenital Heart Disease
New Designed ePTFE Valved Conduits for Surgical Reconstruction of Right-ventricular Outflow Tract
Valved conduits used for the reconstruction of right-ventricular outflow tract are applied in the surgical repair of complex congenital heart disease(CHD) such as pulmonary atresia(PA), truncus arteriosus, severe tetralogy of…
- Conditions
- Right Ventricular Outflow Tract Absent, Congenital Heart Disease, Pulmonary Valve Disorders
- Trial name
- NCT04152967
- Testing
- new-designed PTFE valved conduits, Bovine jugular vein valved conduits
- Where
- 3 sites in China
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University
Aortic Valve Disease, Aortic Valve Stenosis
China Valve Registry Study-1
With the aging of Chinese population, degenerative valvular disease is becoming more and more frequent, which has brought a heavy burden to our society.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency, Heart Valve Diseases
- Trial name
- CHIVAS-1 (NCT02623907)
- Volunteers
- 2,000 people
- Sponsor
- Shanghai Zhongshan Hospital
Aortic Stenosis, Severe
TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
The primary efficacy objective is to determine whether a TAVI procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to TAVI procedure performed by the same operators in centers…
- Trial name
- TRACS (NCT05751577)
- Testing
- TAVI WITHOUT ON-SITE SURGERY, TAVI WITH ON-SITE SURGERY
- Where
- 14 sites in Italy
- Volunteers
- 657 people
- Sponsor
- Azienda Usl di Bologna
Stroke, Aortic Valve Stenosis
Acute STROke Complicating TAVI - Management and Outcomes
Periprocedural complications of trans catheter aortic valve implantation, and particularly the occurrence of stroke has a marked impact on survival and quality of life.
- Conditions
- Stroke, Aortic Valve Stenosis, Periprocedural Complication
- Trial name
- ASTRO-TAVI (NCT05241821)
- Testing
- Mechanical thrombectomy, Thrombolytic Agent
- Where
- Israel
- Volunteers
- 484 people
- Sponsor
- Rabin Medical Center
Aortic Stenosis and Lipoprotein(a) Levels
Early Aortic Valve Lipoprotein(a) Lowering Trial
Aortic valve disease is the most common form of heart valve disease and is a major burden to society. Aortic valve disease is also expected to become more prevalent with the aging of the Canadian population.
- Trial name
- EAVaLL (NCT02109614)
- Testing
- Extended release Niacin
- Where
- 3 sites in Canada
- Sponsor
- George Thanassoulis
Calcific Aortic Valve Disease
A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)
This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 2 arm study to evaluate the efficacy and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with…
- Trial name
- NCT05143177
- Testing
- Evogliptin
- Where
- 25 sites in United States, Canada
- Volunteers
- 486 people
- Sponsor
- REDNVIA Co., Ltd.
Valvular Heart Disease, Coronary Artery Disease
Cardiovascular Acoustics for Early Disease Detection
There are many types of heart disease. Two of the most common causes are narrowings within the blood vessels that supply the heart (known as coronary artery disease), or valves within the heart becoming narrowed (stenosed) or…
- Trial name
- ACOUTECT (NCT07496775)
- Where
- United Kingdom
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Hypertrophic Obstructive Cardiomyopathy
Quantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress Test
The objectives of this study are to determine if the left ventricle outflow tract (LVOT) gradients may be reproduced with dobutamine (DBT) provocation test in obstructive HCM patients under general anesthesia and to analyze the…
- Trial name
- NCT05025644
- Testing
- Pre and post-CPB Drug: Dobutamine Hydrochloride, Post-CPB Drug: Dobutamine Hydrochloride
- Volunteers
- 60 people
- Sponsor
- University Health Network, Toronto
Myocardial Bridging, Obstructive Hypertrophic Cardiomyopathy
Myocardial Bridging in Obstructive Hypertrophic Cardiomyopathy
This study investigated the impact of myocardial bridging (MB) and its characteristics on preoperative atrial fibrillation and survival in patients with obstructive hypertrophic cardiomyopathy (oHCM).
- Conditions
- Myocardial Bridging, Obstructive Hypertrophic Cardiomyopathy, Atrial Fibrillation (AF)
- Trial name
- MB in oHCM (NCT06598995)
- Testing
- Coronary artery bypass grafting or unroofing
- Where
- China
- Volunteers
- 968 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure
The ShortCut™ Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets in patients who are presented…
- Trial name
- NCT04952909
- Testing
- ShortCut™
- Where
- 23 sites in United States, France and 3 more
- Volunteers
- 60 people
- Sponsor
- Pi-cardia
Mitral Regurgitation, Valvular Heart Disease
Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population
To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.
- Conditions
- Mitral Regurgitation, Valvular Heart Disease, Heart Failure
- Trial name
- LEAFLET I (NCT06634121)
- Testing
- Transcatheter mitral valve edge-to-edge repair (M-TEER)
- Where
- Germany
- Volunteers
- 180 people
- Sponsor
- LMU Klinikum
Aortic Valve Stenosis
Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
To investigate whether the collagen-based MANTA vascular closure device (VCD) is superior to suture-based VCDs in preventing vascular access site complications in patients undergoing transfemoral transcatheter aortic valve…
- Trial name
- MASH-TAVI (NCT03811119)
- Testing
- MANTA vascular closure device, Suture based vascular closure device
- Where
- Netherlands
- Volunteers
- 151 people
- Sponsor
- Erasmus Medical Center
Hypertrophic Cardiomyopathy
Assessment of Wall Thickness in Hypertrophic Cardiomyopathy
Assessment of wall thickness in hypertrophic cardiomyopathy (HCM) is of diagnostic and prognostic importance given its known association with sudden cardiac death.
- Trial name
- NCT02234336
- Testing
- Noncontrast echocardiography, Contrast Echocardiography, Cardiac magnetic resonance imaging
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Mayo Clinic
Aortic Valve Stenosis
The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low…
- Trial name
- 3MTAVR (NCT02287662)
- Testing
- Vancouver 3M Clinical Pathway
- Where
- Canada
- Volunteers
- 411 people
- Sponsor
- BC Centre for Improved Cardiovascular Health
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 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.
Aortic Stenosis Disease
Aortic Stenosis - Prognosis, Risk and Outcomes
The investigators will prospectively enroll 300 patients undergoing TAVI at Sahlgrenska University Hospital, which is the second largest TAVI hospital in Sweden.
- Trial name
- MASTER (NCT06863883)
- Where
- 2 sites in Sweden
- Volunteers
- 300 people
- Sponsor
- Vastra Gotaland Region
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