Clinical trials: Stenoses, Aortic
Coronary Artery Disease, Aortic Valve Stenosis
Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation
The aim of this study is to evaluate the effect of routine FFR-guided complete revascularization with PCI compared to conservative management in patients with concomitant coronary artery disease who are undergoing TAVI.
- Conditions
- Coronary Artery Disease, Aortic Valve Stenosis, TAVI, PCI
- Trial name
- NOTION-3 (NCT03058627)
- Testing
- PCI
- Where
- 12 sites in Denmark, Finland and 2 more
- Volunteers
- 454 people
- Sponsor
- Thomas Engstrom
Acute Kidney Injury
Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation
Randomized controlled, single-center trial randomizing patients with chronic kidney disease and symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI).
- Trial name
- NCT04537325
- Testing
- RenalGuard system
- Where
- Germany
- Volunteers
- 98 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Obstructive Cardiomyopathy, Hypertrophic, Non-obstructive Hypertrophic Cardiomyopathy
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
The main purpose of the study is to determine the changes in symptoms and functional limitations in participants with symptomatic hypertrophic cardiomyopathy (HCM) treated with sotagliflozin as compared to placebo.
- Trial name
- SONATA-HCM (NCT06481891)
- Testing
- Sotagliflozin
- Where
- 108 sites in United States, Argentina and 17 more
- Volunteers
- 500 people
- Sponsor
- Lexicon Pharmaceuticals
Bicuspid Aortic Valve, Aortic Valve Stenosis
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients…
- Conditions
- Bicuspid Aortic Valve, Aortic Valve Stenosis, Aortic Aneurysm, Heart Diseases
- Trial name
- ARDITAV (NCT05708118)
- Testing
- Echocardiographic assessment., Computed-tomography assessment
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Aortic Stenosis, Fibrosis
Angiogenesis and Fibrosis in Aortic Stenosis
Angiogenesis and fibrosis lie at the heart of a number of fundamental processes responsible for cardiovascular disease. In this proposal, the investigators intend to build upon a highly successful programme of studies exploring…
- Conditions
- Aortic Stenosis, Fibrosis, Neovascularization, Pathologic
- Trial name
- NCT01837160
- Testing
- Cardiac MRI scan, CT-PET scan, Echocardiogram
- Where
- United Kingdom
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
Coronary Artery Disease, Heart Failure
Stress Echo 2030: the Novel ABCDE-(FGLPR) Protocol to Define the Future of Imaging
With stress echo (SE) 2020 study, a new standard of practice in stress imaging was developed and disseminated: the ABCDE protocol for functional testing within and beyond CAD.
- Conditions
- Coronary Artery Disease, Heart Failure, Hypertrophic Cardiomyopathy, Congenital Heart Disease
- Trial name
- SE2030 (NCT05081115)
- Testing
- ABCDE-Stress Echo, SE diastolic assessment, SE Right ventricular function assessment
- Where
- Italy
- Volunteers
- 10,000 people
- Sponsor
- Fatebenefratelli Hospital
Aortic Valve Stenosis, Heart Valve Diseases
First in Man Study of the JenaValve TAVI Plus System Transfemoral
The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- CP-0001 (NCT02818959)
- Testing
- JenaValve Pericardial TAVR System
- Where
- 2 sites in Germany
- Volunteers
- 7 people
- Sponsor
- JenaValve Technology, Inc.
Sarcopenia, Aortic Valve Stenosis
Overal Survival After TAVI According to Sarcopenia
The goal of this observational study is to compare the overal survival after transcatheter aortic valve implantation (TAVI) according to sarcopenia status evaluated from preprocedural CT scans.
- Trial name
- TAVI_Sarx (NCT05672160)
- Testing
- CT evaluated sarcopenia
- Where
- Czechia
- Volunteers
- 930 people
- Sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.
Cardiomyopathy, Hypertrophic Obstructive
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy
This is a randomized, double-blind, placebo-controlled, sequential, 5-day treatment, ascending dose study in subjects with obstructive HCM aged 18-70 years.
- Trial name
- NCT04418297
- Testing
- CT-G20
- Where
- 11 sites in United States, Poland and 1 more
- Volunteers
- 23 people
- Sponsor
- Celltrion
Severe Aortic Stenosis
Coronary Access After Evolut FX Plus TAVI: Impact of Commissural Alignment and the Large-Cell Frame Design: ACCESS-FX+ Registry
The ACCESS-FX+ Registry is a prospective, multicenter, single-arm study designed to evaluate the feasibility of coronary access after transcatheter aortic valve implantation (TAVI) using the Evolut FX Plus transcatheter heart…
- Trial name
- NCT07813273
- Volunteers
- 122 people
- Sponsor
- Yonsei University
Aortic Stenosis
Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement
Background: Transcatheter aortic valve replacement (TAVR) is a non-surgical alternative to standard surgical aortic valve replacement.
- Trial name
- NCT03432494
- Testing
- Transcaval closure device (TCD)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis
The aortic valve is the main outlet valve from the heart. This valve can become diseased and narrowed when it needs to be replaced with an artificial valve.
- Trial name
- NCT01358513
- Where
- United Kingdom
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
Aortic Valve Stenosis, AV Block
Prospective Arm of Conduct - Edwards SAPIEN3 PPI Registry
There are procedure related risk factors for permanent pacemaker implantation (PPI) that can be identified and assessed in a prospective cohort of 300 patients at high risk for PPI Prospective, multicenter, European registry in…
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Trial name
- Conduct-pro (NCT03715894)
- Testing
- transcatheter valve implantation
- Where
- 5 sites in Germany, Netherlands and 1 more
- Volunteers
- 300 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Aortic Valve Stenosis, Structural Valve Deterioration
Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical…
- Trial name
- NCT06049654
- Testing
- NVT ALLEGRA TAVI System TF, EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
- Where
- 12 sites in Italy, Spain and 1 more
- Volunteers
- 104 people
- Sponsor
- Fundación EPIC
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation
HEParin Antagonisation in Transcatheter Aortic Valve Implantation
Unfractioned heparin is usually given in a defined dosage during transfemoral TAVI. Activated Clotting Time (ACT) is usually used to measure the heparin effect.
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Protamine Sulfate Overdose
- Trial name
- HepaTAVI (NCT05422170)
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Hypertrophic Cardiomyopathy
Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy
Eligible subjects will wear 4 consecutive external monitoring devices for a total of 28 days of monitoring.
- Trial name
- NCT03182153
- Testing
- Extended Cardiac Monitoring
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- Atlantic Health System
Transcatheter Aortic Valve Implantation (TAVI)
The EASE-IT CT Registry
ICA is not always required for a pre-TAVI workup of octogenarians and can be substituted by CTA resulting in a streamlined pre-procedural workup of patients without compromising patient safety.
- Trial name
- NCT05750173
- Testing
- Streamlining of the pre-procedural patient pathway
- Where
- 6 sites in Austria, Germany
- Volunteers
- 150 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Aortic Stenosis
Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: SAINT-TAVR Calcium Registry
The goal of this observational study is to learn about the long-term effects of aortic valve annular calcification in patients undergoing transcatheter aortic valve replacement (TAVR).
- Trial name
- SAINT-TAVR Ca (NCT06722066)
- Testing
- Transcatheter aortic valve replacement with ballon-expandable or self-expandable valves
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- Eunpyeong St. Mary's Hospital
Hypertrophic Cardiomyopathy
Incidence of Hypertrophic Cardiomyopathy in Infants of Diabetic Mothers Attending in NICU at Assiut University Children Hospital During One Year
To evaluate all full term infants of diabetic mother for the presence of hypertrophic cardiomyopathy who admitted in NICU at Assiut University Children Hospital and to follow up of these cases after 6 months for recovery.
- Trial name
- NCT06048562
- Testing
- echocardiography
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Assiut University
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