Clinical trials: Aortic Valve Stenosis, completed
Aortic Valve Stenosis
Engager Direct Aortic Clinical Study
To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach.
- Trial name
- NCT01789567
- Testing
- Engager™ aortic valve
- Where
- 6 sites in Czechia, Germany and 1 more
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Aortic Valve Stenosis
Indication of Permanent Cardiac Parcing After Tanscatheter Aortic Valve Implantation
Since 2002, transcatheter aortic valve implantation (TAVI) has resulted in a dramatic change in the prognosis of patients with aortic valve stenosis illegible to surgery.
- Trial name
- TAVISTIM (NCT02337140)
- Testing
- Pacemaker SORIN Group KORA DR, transcatheter aortic valve implantation (TAVI)
- Where
- France
- Volunteers
- 165 people
- Sponsor
- University Hospital, Montpellier
Valve-in-valve Procedures, Aortic Stenosis
The ShortCut™ Continued Access Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
- Conditions
- Valve-in-valve Procedures, Aortic Stenosis, Coronary; Obstruction
- Trial name
- ShortCut-CAS (NCT06211296)
- Testing
- Shortcut
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pi-cardia
Aortic Valve Disease, Transcatheter Aortic Valve Replacement
The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures
TAVR patients exhibiting post-procedural residual AR had higher mortality and hospitalization rates due to heart failure, with the extent of this association increasing proportionally to the severity of the regurgitation.
- Conditions
- Aortic Valve Disease, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis, Hemodynamic Measurement
- Trial name
- SAVVY (NCT05082337)
- Testing
- SAVVY guidewire
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
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 Valve Stenosis
DEFLECT III: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI
A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter aortic valve implantation.
- Trial name
- TAVI (NCT02070731)
- Testing
- TriGuard HDH
- Where
- 14 sites in France, Germany and 4 more
- Volunteers
- 86 people
- Sponsor
- Keystone Heart
Aortic Valve Stenosis
A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement
This study is being performed in patients who have undergone transcatheter aortic valve replacement (TAVR) for aortic stenosis. The goal is to obtain pilot and feasibility data on a novel post-procedure rehabilitation strategy…
- Trial name
- NCT03270124
- Testing
- Daily Activity Goal, Resistance Exercises, Daily Activity Recording
- Where
- 5 sites in United States
- Volunteers
- 85 people
- Sponsor
- Vanderbilt University Medical Center
Heart Failure, Diastolic, Aortic Valve Stenosis
Changes in Cardiac Deformation Following Physiologic Alterations and Inotropic Support.
The investigators want to compare the effects of two drugs, levosimendan and milrinone, on cardiac muscle, both in terms of contractility and relaxation. Half of the participants will be randomized to each drug.
- Conditions
- Heart Failure, Diastolic, Aortic Valve Stenosis, Monitoring, Physiologic, Physiology
- Trial name
- NCT02408003
- Testing
- Levosimendan, Milrinone
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- Sahlgrenska University Hospital
Severe and Symptomatic Aortic Stenosis, Undergoing TAVI
Vascular Complications and Bleeding After Transfemoral TAVI
Since the first implantation by Cribier, transcatheter aortic valve implantation (TAVI) revolutionized the management of severe symptomatic aortic stenosis.
- Trial name
- NCT03865043
- Where
- France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Montpellier
Chest Pain, Severe Aortic Stenosis
Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease
Exertional angina is common symptom in patients with severe aortic stenosis (AS) without obstructive coronary artery disease (CAD).
- Trial name
- NCT02575768
- Testing
- Adenosine-stress cardiac magnetic resonance imaging
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Samsung Medical Center
Aortic Valve Stenosis, Cardiovascular Diseases
Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)
The aortic valve is located between the left ventricle and the aorta. Patients with symptomatic, severe aortic valve stenosis conventionally have it surgically replaced requiring direct access to the heart through the chest.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Ventricular Outflow Obstruction
- Trial name
- GALILEO-4D (NCT02833948)
- Testing
- Acetylsalicylic acid, Clopidogrel, Rivaroxaban
- Where
- 25 sites in United States, Canada and 5 more
- Volunteers
- 231 people
- Sponsor
- ECRI bv
Aortic Valve Stenosis
Pre- and Post-TAVI Patient Assessment: Advancing Outcome Precision in Aortic Valve Therapy
The aim of this study is to evaluate the combined utility of the left atrial coupling index (LACI) and left ventricular speckle tracking echocardiography (LVSTE) in improving risk stratification and outcome prediction for…
- Trial name
- NCT07179302
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 2 sites in Egypt, Saudi Arabia
- Volunteers
- 100 people
- Sponsor
- Damanhour University
Aortic Valve Stenosis, Mitral Regurgitation
Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform
This multi-center, prospective, cluster-randomized controlled trial will evaluate Tempus Next automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Valve…
- Trial name
- ALERT (NCT06099665)
- Testing
- Automated alert
- Where
- 6 sites in United States
- Volunteers
- 2,118 people
- Sponsor
- Tempus AI
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic…
- Trial name
- PII S3i (NCT03222128)
- Testing
- TAVR
- Where
- 51 sites in United States
- Volunteers
- 1,074 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System
To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical…
- Trial name
- NCT03043404
- Testing
- Transcatheter aortic valve replacement
- Where
- 2 sites in Australia
- Volunteers
- 4 people
- Sponsor
- Boston Scientific Corporation
Calcific Aortic Stenosis
Effective Management of Calcific Aortic Stenosis in the Elderly
Although aortic valve replacement is recommended for any symptomatic severe calcific aortic stenosis, the therapeutic decision may be difficult. because of patient age and comorbidities.
- Trial name
- RAC (NCT03343314)
- Volunteers
- 1,101 people
- Sponsor
- French Cardiology Society
Hypertrophic Cardiomyopathy, Long QT Syndrome
Exercise in Genetic Cardiovascular Conditions
The goal is to determine how lifestyle and exercise impact the well-being of individuals with hypertrophic cardiomyopathy (HCM) and long QT syndrome (LQTS).
- Trial name
- LIVE-HCM/LQT (NCT02549664)
- Where
- 36 sites in United States, Australia and 3 more
- Volunteers
- 4,299 people
- Sponsor
- Yale University
Heart Disease, Aging
Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement.
Background: The prevalence of both senile cardiac amyloidosis (CA) and aortic stenosis (AS) markedly increases with age. Aortic stenosis increases left ventricular pressure overload.
- Conditions
- Heart Disease, Aging, Amyloidosis, Aortic Valve Stenosis
- Trial name
- AMYLOCARTESIAN (NCT02260466)
- Testing
- a basal LV septum biopsy
- Where
- 5 sites in France
- Volunteers
- 186 people
- Sponsor
- French Cardiology Society
Cardiac Disease, Pulmonary Disease, Healthy Volunteer
Exploratory Study of the Diagnostic Potential of an Innovative Thoracic Vibration Analysis Technique
Heart and lung disease are two major causes of hospitalisation and mortality in France (4-8). Together, these two diseases affect several million people in France, either acutely or chronically.
- Conditions
- Cardiac Disease, Pulmonary Disease, Healthy Volunteer, Aortic Stenosis Disease, Mitral Regurgitation
- Trial name
- AIRFORCE2 (NCT06661200)
- Testing
- SMC signal recording
- Where
- France
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- University Hospital, Caen