Clinical trials: Stenoses, Aortic
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System FOUNDATION Study
The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Rapid Deployment Valves
- Trial name
- FOUNDATION (NCT02338154)
- Where
- 27 sites in Austria, Denmark and 7 more
- Volunteers
- 516 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
Telematic Intervention for Reversing Frailty Among Older Patients with Aortic Stenosis Undergoing Transcatheter Aortic Valve Intervention. the TELE-FRAIL TAVI Clinical Trial
The TELE FRAIL clinical trial is a randomized trial designed to compare, among older frail patients with aortic stenosis undergoing transcatheter valve intervention (TAVI), the impact of usual care after vs a telematic…
- Trial name
- TELEFRAIL TAVI (NCT06742970)
- Testing
- Telematic intervention
- Where
- Spain
- Volunteers
- 206 people
- Sponsor
- Spanish Society of Cardiology
Congenital Heart Disease, Aortic Valve Stenosis
Effect of Fetal Aortic Valvuloplasty on Outcomes
In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects.
- Conditions
- Congenital Heart Disease, Aortic Valve Stenosis, Fetal Cardiac Disorder, Hypoplastic Left Heart Syndrome
- Trial name
- FASSprosp (NCT05386173)
- Testing
- Fetal aortic balloon dilatation
- Where
- 13 sites in United States, Austria and 6 more
- Volunteers
- 200 people
- Sponsor
- Queen Silvia Children's Hospital, Gothenburg, Sweden
Aortic Valve Stenosis
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
The primary objective of this study is to collect data to confirm the performance and safety of the True™ Flow Valvuloplasty Perfusion Catheter during dilatation of the aortic valve in the preparation for Transcatheter Aortic…
- Trial name
- True™Flow (NCT02847546)
- Testing
- True™ Flow Valvuloplasty Perfusion Catheter
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- C. R. Bard
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- TRANSFORM™ (NCT01700439)
- Testing
- EDWARDS INTUITY valve
- Where
- 29 sites in United States
- Volunteers
- 934 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis
Supra-Annular vs. Annular ValvEs for Small Annuli
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
- Trial name
- SAVE (NCT04372381)
- Testing
- Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
- Where
- 3 sites in United States
- Sponsor
- University of Arizona
Hypertrophic Cardiomyopathy
The Effect of Metoprolol in Patients With Hypertrophic Obstructive Cardiomyopathy.
Hypertrophic obstructive cardiomyopathy (HOCM) patients often develop disabling symptoms of heart failure. Current treatment strategies are predicated on the empirical use of long-standing drugs, such as beta-adrenergics…
- Trial name
- TEMPO (NCT03532802)
- Testing
- Metoprolol Succinate
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- Steen Hvitfeldt Poulsen
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
Severe Aortic Valve Stenosis
Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation
The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure.
- Trial name
- POP ATLANTIS (NCT06168370)
- Testing
- CT guided strategy
- Where
- Netherlands
- Volunteers
- 2,500 people
- Sponsor
- St. Antonius Hospital
Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy
Metabolomic Study of All-age Cardiomyopathy
This study aims to 1)characterize the differentially expressed metabolites between cardiomyopathy patients and healthy controls,2)identify the specific biomarkers associated with outcomes or risk evaluation in patients with…
- Conditions
- Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy, Left Ventricular Non-compaction
- Trial name
- MAC (NCT03061994)
- Where
- China
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
Aortic Valve Stenois
Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis
The purpose of this study is to confirm if myocardial protection effect can be obtained by intravenous administration of glutamine in patients undergoing aortic valve replacement with severe aortic stenosis (who are at high risk…
- Trial name
- NCT03341169
- Testing
- N(2)-L-Alanine L-Glutamine dipeptide
- Where
- South Korea
- Volunteers
- 108 people
- Sponsor
- Yonsei University
Patients Above 18 Years, Patient Discharge
One Year Pacing Dependency After TAVR
Pace maker implantation after the procedure of TAVR can be estimated at 15% of patients. However, some studies have shown that the conduction disturbances after TAVR could resolve over time, and that roughly between one- and…
- Conditions
- Patients Above 18 Years, Patient Discharge, Pacing Therapy, Aortic Stenosis (Treated With TAVI)
- Trial name
- PACETAVI (NCT06756282)
- Testing
- Pacemaker and defibrillator
- Where
- France
- Volunteers
- 90 people
- Sponsor
- University Hospital, Montpellier
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
- Trial name
- MAPLE-HCM (NCT05767346)
- Testing
- Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg), Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)
- Where
- 71 sites in United States, Brazil and 11 more
- Volunteers
- 175 people
- Sponsor
- Cytokinetics
Carotid Artery Stenosis, Aortic Calcification
Aortic Calcification - is it a Marker for Carotid Artery Stenosis?
Atherosclerosis is the major contributor for the morbidity and mortality for the variety of cardiovascular diseases. Aortic calcification on x-ray is a marker for arterial atherosclerosis and an independent prognostic factor for…
- Trial name
- NCT01458860
- Volunteers
- 200 people
- Sponsor
- Ziv Hospital
Aortic Valve Stenosis, Aortic Valve Calcification
ACURATE Enhance Post Market Study
The objective of the ACURATE Enhance study is to assess valve frame expansion and hemodynamics in a routine clinical setting when optimized procedural steps for valve implantation are followed.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- Trial name
- NCT06959862
- Testing
- Transcatheter Aortic Valve Implantation/Replacement
- Sponsor
- Boston Scientific Corporation
Murmur, Heart, Aortic Valve Stenosis
Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes
The Eko CORE and DUO stethoscopes are FDA-approved electronic devices that have the capacity to record heart sounds. The study seeks to expand murmur detection to include VHD classification through the development of novel ML…
- Conditions
- Murmur, Heart, Aortic Valve Stenosis, Tricuspid Regurgitation, Mitral Regurgitation
- Trial name
- NCT04400513
- Testing
- Use of Eko CORE and Eko DUO electronic stethoscopes
- Where
- United States
- Volunteers
- 1,145 people
- Sponsor
- Eko Devices, Inc.
Aortic Valve Stenosis, Chronic Kidney Diseases
Impact of Trans-catheter Aortic Valve Implantation on Renal Function
Both contrast-induced acute kidney injury (AKI) and pre-existing chronic kidney disease are associated with an increased mortality risk in patients requiring aortic valve replacement.
- Conditions
- Aortic Valve Stenosis, Chronic Kidney Diseases, Renal Failure Acute Chronic
- Trial name
- TAVIKOD (NCT07626710)
- Testing
- Trans-catheter aortic valve implantation (TAVI)
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Aortic Valve Stenosis
Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System
Collect and evaluate the long term safety data.
- Trial name
- NCT01497418
- Where
- 2 sites in Canada
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA
This clinical trial, a prospective, randomized, multicenter study, assigns patients to either videodensitometry-guided TAVI or conventional TTE/TEE-guided TAVI (stand of care), with the primary endpoint being regurgitation…
- Trial name
- NCT06891079
- Testing
- Videodensitometric guided, Stand of care guided
- Where
- 2 sites in China
- Volunteers
- 320 people
- Sponsor
- Xijing Hospital
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
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