Clinical trials: Valve Disease, Aortic
Aortic Valve Stenosis, Coronary Artery Disease
Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR
The objective of this study is to evaluate the relationship between fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFRct) before transcatheter aortic valve replacement (TAVR) and FFR after…
- Trial name
- FORTUNA (NCT03665389)
- Testing
- iFR / FFR measurement
- Volunteers
- 25 people
- Sponsor
- Kobe University
Hypertrophic Cardiomyopathy (HCM), Atrial Fibrillation (AF)
Mechanisms of Atrial Pathoelectrophysiology in HCM
This study aims to learn why atrial fibrillation (AF), a type of irregular heartbeat, happens more often and is harder to treat in people with hypertrophic cardiomyopathy (HCM).
- Trial name
- MAP HCM (NCT07454135)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Type A Aortic Dissection, Ascending Aortic Dissection
Outcomes of Aortic Dissection Repair
Type A aortic dissection (TAAD) is a potentially life-threatening pathology associated with significant risk of mortality and morbidity.
- Conditions
- Type A Aortic Dissection, Ascending Aortic Dissection, Aortic Diseases, Aortic Arch
- Trial name
- STAAD (NCT05927090)
- Testing
- Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair, Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR), Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)
- Where
- France
- Volunteers
- 1,200 people
- Sponsor
- Centre Cardiologique du Nord
Symptomatic Aortic Stenosis
First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System
The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe…
- Trial name
- SJM TAVI FIH (NCT01487330)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Insufficiency
Results of the Aortic Valve Reconstruction in Children
Aortic valve disease counts up to 5% of cases of congenital heart disease being one of the most common congenital malformations of the cardiovascular system.
- Trial name
- NCT04162444
- Testing
- Physical examination, The Ross Classification for Heart Failure in Children, The Aristotle score
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- National Medical Research Center for Children's Health, Russian Federation
Aortic Valve Disease
Health Status of Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2018)
The overall project aim is to study outcomes following aortic valve replacement with either mechanical valves or bioprostheses by retrieving data from the main social security carriers in Austria for the years 2010-2018.
- Trial name
- NCT04900909
- Testing
- Aortic Valve Replacement
- Volunteers
- 13,993 people
- Sponsor
- Medical University of Vienna
Aortic Valve Disorder
Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage
Atrial fibrillation (AF) is a common comorbidity of patients candidates to transcatheter aortic valve implantation (TAVI). The management of chronic oral anticoagulation (OAC) for the prevention of ischemic stroke is very…
- Trial name
- TAVI-LAAC (NCT02678871)
- Testing
- Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations), WATCHMAN
- Where
- 6 sites in Germany, Italy and 2 more
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
This is an early study of a catheter-based minimally invasive procedure called SESAME to slice thick heart muscle as described below.
- Conditions
- Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction, Systolic Anterior Motion
- Trial name
- NCT07806149
- Testing
- SESAME Procedure
- Where
- 8 sites in United States
- Volunteers
- 200 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Hypertension, Aortic Aneurysm
Measurement of Heart-carotid Pulse Wave Velocity (hcPWV) by Laser Doppler Vibrometry (LDV)
Aortic stiffness is an important imaging biomarker of vascular aging. The ascending aorta is the most elastic segment, and it is excluded by reference non-invasive method carotid to femoral pulse wave velocity (PWV).
- Conditions
- Hypertension, Aortic Aneurysm, Bicuspid Aortic Valve, Marfan Syndrome
- Trial name
- InSide-CC (NCT05711693)
- Testing
- Laser doppler vibrometry (LDV), heart(cordium) carotid pulse wave velocity (ccPWV), Blood pressure and heart rate measurement, carotid to femoral PWW measurement
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Aortic Valve Stenosis, Ventricular Dysfunction, Left
Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure
Calcified aortic stenosis is the most frequent valvulopathy in Europe and North America. Aortic stenosis is an obstacle to the ejection of blood from the left ventricle to the aorta and leads to morphological changes in the left…
- Trial name
- PRAM-TAVI (NCT03385785)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Central Hospital, Nancy, France
Cerebral Stroke, Aortic Valve Disease
Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement
The purpose of this study is to compare the incidence of silent and apparent cerebral embolism between conventional and minimal-invasive transfemoral aortic valve repair.
- Trial name
- NCT00883285
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- University Hospital, Bonn
Aortic Valve Disease, Mitral Valve Disease
The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
The goal of this open, prospective, multicenter study is analyze long-term outcomes of aortic/mitral valve replacement using the "UniLine" bioprosthesis in patients with acquired aortic or mitral valve diseases.
- Trial name
- Uniline (NCT06025149)
- Where
- Russia
- Volunteers
- 300 people
- Sponsor
- Closed Joint-Stock Company NeoCor
Aortic Valve Stenosis
Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation
A single-center, investigator-initiated, single arm interventional study in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) in the Erasmus Medical Center in Rotterdam (NL).
- Trial name
- REDOX-TAVI (NCT04171726)
- Testing
- Edoxaban
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Erasmus Medical Center
Heart Failure, Aortic Stenosis
Heart Failure and Aortic Stenosis Transcriptome
This study is aimed to investigate the global transcriptome in order to determine the expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro noncoding-RNAs (miRNAs) in heart failure (HF) and…
- Trial name
- RNA-HF-AS (NCT03268135)
- Testing
- measurement of RNAs
- Where
- 2 sites in Italy
- Volunteers
- 500 people
- Sponsor
- IRCCS Policlinico S. Donato
Aortic Stenosis, Heart Failure
High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis (Tyrolean Aortic Stenosis Study-2)
TASS-2 (Tyrolean Aortic Stenosis Study-2) aims to characterize the clinical value of minimally elevated troponin T plasma levels both in patients with asymptomatic and symtomatic aortic stenosis.
- Conditions
- Aortic Stenosis, Heart Failure, Syncope, Angina Pectoris
- Trial name
- TASS-2 (NCT02448485)
- Testing
- Aortic Valve Intervention (surgical or transcatheter)
- Where
- Austria
- Volunteers
- 10,000 people
- Sponsor
- Medical University Innsbruck
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Elite Valve System
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a…
- Trial name
- MISSION (NCT02907463)
- Where
- 23 sites in Austria, Denmark and 7 more
- Volunteers
- 280 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease
Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement
Since 2009, positive experiences with right anterior minithoracotomy as an approach to aortic valve replacement are extensively practiced in our institution.
- Trial name
- RVAOMITAVA (NCT04455165)
- Testing
- Aortic valve replacement
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Centre Hospitalier La Chartreuse
Cardiovascular Diseases, Heart Diseases
Genetic Analysis of Familial Hypertrophic Cardiomyopathy
To map the genetic defect responsible for familial hypertrophic cardiomyopathy.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Myocardial Diseases, Cardiomyopathy, Hypertrophic
- Trial name
- NCT00005251
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Valve Replacement
PERCEVAL Pivotal Trial
The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community.
- Trial name
- NCT00860730
- Testing
- Aortic valve replacement with Perceval aortic heart valve
- Where
- 9 sites in Belgium, France and 2 more
- Volunteers
- 150 people
- Sponsor
- Corcym S.r.l
Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement
This study, called the EuroDafodil Registry, is being conducted to understand how safe and effective the Dafodil™ and Dafodil Neo™ Pericardial Bioprosthetic heart valves are when used in routine medical practice.
- Trial name
- NCT07379112
- Testing
- Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve
- Volunteers
- 500 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
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