Clinical trials: Stenosis, Aortic
Aortic Valve Stenosis, Aortic Valve Surgery
Early Surgery for Patients With Asymptomatic Aortic Stenosis
Many cardiologists are convinced that early surgery in asymptomatic aortic stenosis (AS) saves lives. However there is currently no direct evidence for this and most recommendations from the ESC/ EACTS or ACC/ AHA in this field…
- Trial name
- ESTIMATE (NCT02627391)
- Testing
- Early surgical aortic valve replacement, Delayed Surgical aortic valve replacement
- Where
- France
- Volunteers
- 360 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hypertrophic Cardiomyopathy
A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy
The purpose of this research study is to understand more about various heart rhythms (electrical problems) in persons with hypertrophic cardiomyopathy with and without sleep apnea.
- Trial name
- NCT04112290
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- Mayo Clinic
AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency
Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with TAVR without embolic protection (unprotected TAVR).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency, Aortic Valve Regurgitation, Aortic Valve Replacement
- Trial name
- EMBLOK II (NCT07129421)
- Testing
- EMBLOK™ Embolic Protection System ("EMBLOK EPS")
- Volunteers
- 560 people
- Sponsor
- Emblok, Inc.
Aortic Stenosis
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the…
- Trial name
- NCT06991517
- Testing
- The ABC Bicuspid Sizing Algorithm
- Where
- 20 sites in Australia, Canada and 6 more
- Volunteers
- 290 people
- Sponsor
- World Health Research Inc.
Pelvic Organ Prolapse
Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse
The aim of our study is to investigate the alterations in connective tissue of vaginal wall in patients with and without pelvic organ prolapse (POP).
- Trial name
- NCT01749696
- Where
- Finland
- Volunteers
- 78 people
- Sponsor
- Turku University Hospital
Aortic Stenosis, Severe
The CardioFit Trial: Exercise Training Before Aortic Valve Surgery
The CardioFit Trial: The feasibility, safety and tolerability of an exercise training programme in patients with severe aortic stenosis prior to aortic valve replacement surgery: A feasibility trial To investigate if a Structured…
- Trial name
- CardioFit (NCT06818110)
- Testing
- Exercise
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
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.
Aortic Stenosis
Aortic Stenosis and PhosphodiEsterase iNhibition With Aortic Valve Replacement (ASPEN-AVR): A Pilot Study
Currently, aortic stenosis (AS) is considered a "surgical disease" with no medical therapy available to improve any clinical outcomes, including symptoms, time to surgery, or long-term survival.
- Trial name
- ASPEN-AVR (NCT01272388)
- Testing
- Tadalafil
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Washington University School of Medicine
Aortic Stenosis
Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography
According to the 2006 ACC/AHA practice guidelines for valvular heart disease, patients with asymptomatic aortic stenosis(AS) should have screening transthoracic echocardiograms (TTE) performed annually for severe disease, every…
- Trial name
- Cassette (NCT01605669)
- Testing
- Tranthoracic Echocardiogram, Cardiac Ascultation Recordings with Electronic stethoscope
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- United States Naval Medical Center, San Diego
Aortic Valve Stenosis
Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis
TAVI is still a relatively new technique that is emerging with advance in the percutaneous and implantable valve technology. Despite its safe use in inoperable and high risk patients with severe symptomatic aortic valve stenosis…
- Trial name
- TAVI (NCT03633383)
- Testing
- Transcatheter aortic valve
- Volunteers
- 50 people
- Sponsor
- Assiut University
Severe, Symptomatic Aortic Stenosis
The SOLACE-AU Clinical Trial
The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.
- Trial name
- SOLACE-AU (NCT01675596)
- Testing
- TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
- Where
- 11 sites in Australia
- Volunteers
- 199 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Aortic Stenosis With COmplex PCI (ASCOP) Features Retrospective Registry on Contemporary Management and Outcomes
To describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Angioplasty, Balloon, Coronary, Coronary Artery Disease
- Trial name
- ASCOP (NCT05750927)
- Testing
- Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Niguarda Hospital
Severe Aortic Stenosis
A Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (Italy).
PAVI-TAVI Registry Overview The PAVI-TAVI Registry is an observational study at Fondazione IRCCS Policlinico San Matteo in Pavia, Italy.
- Trial name
- PAVI_TAVI (NCT07596394)
- Testing
- Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo
- Where
- Italy
- Volunteers
- 500 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Valvular Disease
Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis
Left valvular heart disease has become one of the most common heart disease in Western countries. This disease evolve over many years and are characterized by a long phase where the patient is "asymptomatic".
- Trial name
- PRESSEVAL (NCT01727310)
- Where
- 2 sites in France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Limoges
Aortic Valve Stenosis
Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve
There is limited experience for the balloon expandable THV (transcatheter heart valve) on the need for predilation (ballon aortic valvuloplasty, BAV).
- Trial name
- EASE-IT (NCT02127580)
- Testing
- BAV, without BAV
- Where
- 7 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Severe Aortic Valve Stenosis
Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation
Background: Transcatheter aortic valve replacement (TAVR) has become the preferred therapy for aortic stenosis. Given the growing life-expectancy, the risk of requiring coronary interventions or of developing prosthesis…
- Trial name
- ACA (NCT05097183)
- Testing
- Accurate Commissural Alignment (ACA)
- Where
- 15 sites in Spain
- Volunteers
- 274 people
- Sponsor
- Ignacio J. Amat Santos
Aortic Stenosis
PRessure-based Evaluation of Disease Improvement in the Course of TAVI
The goal of this prospective observational study is to learn if advanced heart pressure wave analysis (using methods called WIA and REPA) can help predict the success of the procedure and long-term recovery in adults (aged 60-90)…
- Trial name
- PREDIC-TAVI (NCT07509554)
- Testing
- Transcatheter aortic valve replacement (TAVR / TAVI)
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Acute Ischemic Stroke, Acute Renal Injury
Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation
The aim of this trial is to assess the safety and efficacy of conestat alfa (Ruconest®, Pharming Technologies B.V.) on renal and cerebral ischemic events in patients undergoing TAVI for severe symptomatic aortic stenosis (AS)…
- Trial name
- PAIR-TAVI (NCT05145283)
- Testing
- Conestat alfa (Ruconest®), NaCl 0.9%)
- Where
- 2 sites in Switzerland
- Volunteers
- 141 people
- Sponsor
- University Hospital, Basel, Switzerland
Aortic Stenosis
PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry
The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.
- Trial name
- PROGRESS (NCT02987894)
- Testing
- ACURATE neo™ Aortic Bioprosthesis
- Where
- 23 sites in Canada, Germany and 2 more
- Volunteers
- 500 people
- Sponsor
- Symetis SA
Aortic Stenosis, Coronary Heart Disease
The Effect of Glucose-Insulin-Potassium Infusion in Patients Undergoing Cardiac Surgery
The purpose of this study is to evaluate the cardioprotective effects of a short term infusion of glucose-insulin-potassium (GIK) during heart surgery.
- Conditions
- Aortic Stenosis, Coronary Heart Disease, Heart Failure
- Trial name
- NCT00788242
- Testing
- Glucose-insulin-potassium
- Where
- 2 sites in Switzerland
- Volunteers
- 200 people
- Sponsor
- Christoph Ellenberger
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