Clinical trials: Severe Aortic Valve Disease
Aortic Stenosis
ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis
Clinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes.
- Trial name
- NCT02909556
- Testing
- Transcatheter aortic valve replacement
- Where
- 9 sites in Denmark, Germany and 1 more
- Volunteers
- 120 people
- Sponsor
- Symetis SA
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
Severe Aortic Stenosis, TAVI\(Transcatheter Aortic Valve Implantation\)
VARC-TAVI VALVE IMPLANTATION)
SUMMARY: The investigators are planning a clinical study to compare two methods of performing a procedure called TAVI, used in patients with severe aortic stenosis.
- Conditions
- Severe Aortic Stenosis, TAVI\(Transcatheter Aortic Valve Implantation\), Vascular Complications
- Trial name
- VARC-TAVI (NCT06177392)
- Testing
- Secondary TAVI access
- Volunteers
- 600 people
- Sponsor
- Hospital Universitario La Paz
Aortic Stenosis, Severe Aortic Stenosis
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
The purpose of this study is to see if having the Transcatheter Aortic Valve Replacement (TAVR) procedure done in a hospital with onsite cardiac surgery available or not, makes a difference on participant outcomes.
- Trial name
- ATLAS (NCT06818006)
- Testing
- Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight, Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight
- Where
- 2 sites in Canada
- Volunteers
- 600 people
- Sponsor
- University of Alberta
Aortic Valve Stenosis
Use of Cardiac-MRI to Predict Results for People With Severe Aortic Stenosis
Background: Aortic valve stenosis is a disease that makes a major heart valve get smaller. This reduces heart function and causes death.
- Trial name
- NCT01905852
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Valve Stenosis
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for…
- Trial name
- NCT03517436
- Testing
- TAVR with CENTERA THV
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Edwards Lifesciences
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
Severe Aortic Stenosis
CLEAR-AS: CT-FFR-Guided Revascularization in Patients With Severe Aortic Stenosis
Severe aortic stenosis (AS) is often accompanied by coronary artery disease (CAD). While coronary computed tomography angiography (CCTA) is routinely used before aortic valve replacement (AVR) to evaluate coronary anatomy, it…
- Trial name
- CLEAR-AS (NCT07469371)
- Testing
- CCTA plus CT-FFR-informed preoperative decision strategy, CCTA-guided preoperative decision strategy
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Yan'an Affiliated Hospital of Kunming Medical University
Calcific Aortic Valve Disease
Exploration of Manidipine to Reverse Aortic Valve Calcification
This is a prospective, randomized, comparative, clinical trial conducted by Wuhan Union Hospital that aims to evaluate the efficacy and safety of manidipine compared to placebo in patients with calcific aortic valve disease with…
- Trial name
- NCT07091136
- Testing
- manidipine
- Volunteers
- 100 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Aortic Regurgitation
Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation
Velocity Vector Imaging may provide reliable and detailed information on left ventricular segmental function in asymptomatic patients with moderate-to severe AR.
- Trial name
- NCT00624884
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Florence Nightingale Hospital, Istanbul
Aortic Valve Stenosis
FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis
The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis.
- Trial name
- NCT05909748
- Testing
- GEMINUS Transcatheter Aortic Valve Implantation system
- Where
- 2 sites in Israel
- Volunteers
- 30 people
- Sponsor
- Valve Medical
Hypertrophic Cardiomyopathy
Efficacy, Safety, and Tolerability of Perhexiline in Subjects With Hypertrophic Cardiomyopathy and Heart Failure
A Study on the Efficacy, Safety, and Tolerability of Perhexiline maleate in Subjects with Hypertrophic Cardiomyopathy and Moderate-To-Severe Heart Failure
- Trial name
- NCT02431221
- Testing
- Perhexiline
- Sponsor
- Heart Metabolics Limited
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7
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, severe aortic…
- Trial name
- PII S3HR/NR7 (NCT03222141)
- Testing
- TAVR Implantation of the THV Prosthesis
- Where
- 40 sites in United States, Canada
- Volunteers
- 583 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Diastolic Dysfunction
Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis
The purpose of this study is to examine the impact of early surgery in patients with asymptomatic severe aortic valve stenosis with signs of subclinical LV dysfunction despite preserved LVEF, with a watchfull waiting approach.
- Trial name
- DANAVR (NCT03972644)
- Testing
- Aortic valve replacement
- Where
- Denmark
- Volunteers
- 1,700 people
- Sponsor
- Odense University Hospital
Aortic Stenosis, Severe
Selection of Transcatheter Heart vaLve With Intermediate Sizing in Patients With Severe Aortic Stenosis Treated With Transcatheter Aortic Valve Replacement
Transcatheter aortic valve implantation (TAVI) has evolved into a standard therapy for severe aortic stenosis across all surgical risk profiles, supported by pivotal trials in high- and low-risk populations.
- Trial name
- SELECT TAVR (NCT07689279)
- Testing
- Transcatheter Heart Valve
- Volunteers
- 604 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Aortic Stenosis
Implantable Sensor in Aortic Stenosis
To establish the relationship between a panel of biological markers obtained from the REVEAL Linq device and exercise performance as judged by cardiopulmonary exercise testing
- Trial name
- ISAS (NCT06826183)
- Testing
- REVEAL Linq device
- Where
- United Kingdom
- Volunteers
- 17 people
- Sponsor
- Barts & The London NHS Trust
Severe Aortic Stenosis
SOURCE XT REGISTRY
This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that…
- Trial name
- NCT01238497
- Testing
- TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
- Where
- 104 sites in Austria, Belgium and 16 more
- Volunteers
- 2,954 people
- Sponsor
- Edwards Lifesciences
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
Tricuspid Regurgitation
Heterotopic Implantation Of the Edwards-Sapien Transcatheter Aortic Valve in the Inferior VEna Cava for the Treatment of Severe Tricuspid Regurgitation (HOVER)
The goal of this study is to determine the short term safety (<30 days) and efficacy (6 months) of the heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena cava for the treatment of severe tricuspid…
- Trial name
- HOVER (NCT02339974)
- Testing
- Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna Cava
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Henry Ford Health System
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