Clinical trials: Severe Aortic Valve Stenosis
Aortic Stenosis
Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis
The optimal timing of surgical intervention remains controversial in asymptomatic patients with very severe aortic stenosis. The investigators therefore try to compare long-term clinical outcomes of early surgery with those of…
- Trial name
- RECOVERY (NCT01161732)
- Testing
- Early surgery
- Where
- 4 sites in South Korea
- Volunteers
- 145 people
- Sponsor
- Asan Medical Center
Aortic Stenosis Symptomatic
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)
First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the safety and performance of the device.
- Trial name
- 2011-03 (NCT03752996)
- Testing
- ACURATE TF™ Aortic Valve System
- Where
- 5 sites in Brazil, Germany
- Volunteers
- 140 people
- Sponsor
- Symetis SA
Aortic Valve Stenosis, Coronary Artery Disease
Correlation of FFR and iFR With Cardiac PET Perfusion in Patients With Severe Aortic Valve Stenosis
Aortic valve stenosis (AS) affects 2-7% of persons > 65 years, symptoms include: angina and dyspnea, dizziness and syncope. Coincidence of coronary artery disease (CAD), also presenting with angina and dyspnea, in patients with…
- Trial name
- TAVI PET (NCT04882488)
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
Aortic Stenosis, Severe
Outcome Prediction in Patients With Aortic Stenosis After TAVI
This study will investigate changes right ventricular function and functional recovery metrics after transcatheter aortic valve implantation
- Trial name
- PREDICT-TAVI (NCT06043180)
- Testing
- Transcatheter aortic valve implantation
- Where
- United Kingdom
- Volunteers
- 69 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Aortic Stenosis, Severe
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
- Trial name
- NCT05172960
- Testing
- SAPIEN X4 THV, SAPIEN X4S
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 1,234 people
- Sponsor
- Edwards Lifesciences
ATTR Amyloidosis Wild Type, Severe Aortic Stenosis
Prevalence of ATTR Cardiac Amyloidosis in Patients Undergoing TAVR
ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (AS). The reasons for this association are not fully known.
- Conditions
- ATTR Amyloidosis Wild Type, Severe Aortic Stenosis, Aortic Valve Stenosis, Middle East Studies
- Trial name
- NCT06015997
- Volunteers
- 100 people
- Sponsor
- Jordan Collaborating Cardiology Group
Aortic Stenosis, Severe
Exercise CMR in (p)LF-LG AS
Patient with paradoxical or conventional low-flow low-gradient aortic stenosis on echocardiographic assessment will undergo physiological exercise-stress CMR in addition to guideline recommended surveys prior to TAVR.
- Trial name
- NCT06129799
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- University of Göttingen
Depression, Aortic Stenosis
Depression and Major Adverse Events in Older Patients Who Undergo a Transcatheter Aortic Valve Implantation
Depression, screened using the Geriatric Depression Scale (GDS) Short Form, has recently been found to be associated with a 3-fold increase in 1-year mortality after aortic valve replacement (AVR) in patients aged 70 or older.
- Trial name
- TAVIDEP (NCT03995914)
- Sponsor
- University Hospital, Montpellier
Aortic Stenosis
PERIGON Japan Trial
The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.
- Trial name
- NCT02686814
- Testing
- 17mm MDT-2215 aortic valve bioprosthesis
- Where
- 10 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Medtronic Cardiac Surgery
Anemia, Aortic Stenosis
Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement
The objective of the study is to evaluate the efficacy of Erythropoietin (EPO) (+ iron) in reducing the rate of red blood cell transfusion requirements in patients with aortic stenosis undergoing transcatheter aortic valve…
- Trial name
- EPICURE (NCT02390102)
- Testing
- Erythropoietin
- Where
- Canada
- Volunteers
- 117 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Severe Aortic Stenosis
Act on Quality of Life in Patients With aortIc Stenosis
Aortic stenosis (AS) is a degenerative process affecting the aortic valve that leads to sclerosis of the valve and limits its opening during cardiac contractions.
- Trial name
- ALPINIST (NCT06477042)
- Testing
- Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score
- Where
- 4 sites in France
- Volunteers
- 240 people
- Sponsor
- Hospices Civils de Lyon
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
Symptomatic Severe Aortic Valve Stenosis in Older Patients
Burden Comorbidities and Transcatheter Aortic Valve Implantation
The aim of the study is to determine whether the burden of comorbidities measured by CIRS-G (Cumulative Illness Rate Scale) is associated with a non-amelioration of the health related quality of life measured by questionnaire…
- Trial name
- TAVIQUAL (NCT01761357)
- Testing
- answering to questionnaires of quality of live
- Where
- 2 sites in France
- Volunteers
- 150 people
- Sponsor
- Nantes University Hospital
Aortic Stenosis, Severe
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement
This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT04944667
- Testing
- TAVR planning
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Centro Medico Teknon
Aortic Valve Stenosis, Malignancy
Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis
As for today, transcatheter aortic valve implantation (TAVI) is indicated only in symptomatic patients with severe aortic stenosis (AS) at high surgical risk.
- Trial name
- TOP-AS (NCT03181997)
- Testing
- Native aortic valve, Transcatheter aortic valve implantation (TAVI)
- Where
- Israel
- Volunteers
- 168 people
- Sponsor
- Rabin Medical Center
Aortic Valve Disease, Coronary Artery Disease
Early Outcomes of Concomitant Transcatheter Aortic Valve Implantation and Off-pump Coronary Artery Bypass Grafting in Management of Severe Symptomatic Aortic Stenosis and Coronary Artery Disease
Study Objectives/Specific Aims Overall Goal: To study the outcomes of patients undergoing TAVI, their subsequent results and complications.
- Trial name
- NCT04525339
- Testing
- TAVI and Off pump CABG
- Where
- Egypt
- Volunteers
- 15 people
- Sponsor
- Assiut University
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis
Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction
According to current European Recommendations on valvular heart disease (VHD), "classical" severe aortic stenosis (AS) is defined by an aortic valve area (AVA) ≤1 cm2 and indexed AVA ≤0.6 cm2/m2, a mean aortic pressure gradient…
- Trial name
- ROTAS (NCT03667365)
- Testing
- aortic valve replacement, strict clinical surveillance
- Where
- 18 sites in Belgium, France
- Volunteers
- 52 people
- Sponsor
- Rennes University Hospital
Severe Aortic Valve Disease
Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve
Objectives: This report presents 5-year outcomes of the rapid-deployment Edwards Intuity TM valve in a single-center prospective study.
- Trial name
- NCT04696926
- Testing
- Edwards Intuity TM Valve implantation
- Where
- France
- Volunteers
- 170 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Aortic Stenosis
Biological Factors Associated With Subclinical Valvular Thrombosis
A prospective, multicentric cohort study including 166 patients with symptomatic aortic stenosis treated with transcatheter aortic valve implantation (TAVI).
- Trial name
- START (NCT03847948)
- Testing
- CT SCAN
- Where
- 2 sites in Spain
- Volunteers
- 166 people
- Sponsor
- Hospital San Carlos, Madrid