Clinical trials: Severe Aortic Stenosis
Aortic Stenosis
ACURATE Neo™ TA Delivery System in Patient With Severe Aortic Stenosis
The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System.
- Trial name
- NCT02950428
- Testing
- ACURATE neo™TA Delivery System
- Where
- 7 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Symetis SA
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
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
Severe Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Observational Study Relating to the Long-term Follow-up of Patients with Severe Aortic Stenosis Evaluated for Percutaneous Aortic Valve Replacement (TAVI).
All patients with severe aortic stenosis undergoing evaluation for TAVI are routinely subjected to a series of assessments: Pre-implantation: thoraco-abdominal CT angiography, coronary angiography, echocardiography, clinical…
- Trial name
- ROARING-TAVI (NCT06679517)
- Testing
- TAVI
- Where
- Italy
- Volunteers
- 600 people
- Sponsor
- University Hospital of Ferrara
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
Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis
To assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with low-gradient, severe aortic stenosis.
- Trial name
- NCT02010177
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Sheba Medical Center
Severe Aortic Valve Stenosis, Cardiovascular Diseases
Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)
Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential…
- Trial name
- IMPROVE (NCT07456280)
- Testing
- Standard care, PhysioMem PM 100 4G ambulatory monitoring system
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Aortic Valve Stenosis
Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human
- Trial name
- NCT04665596
- Testing
- Ultrasound treatment
- Where
- Serbia
- Volunteers
- 10 people
- Sponsor
- Cardiawave SA
Aortic Stenosis
Frailty and Mortality in Older Old With Severe Aortic Stenosis
BACKGROUND.- The frailty syndrome (FS) associates an increase in morbidity and mortality in the elderly patient. When severe and symptomatic, aortic stenosis (AS) is a disease with poor prognosis, the most frequent cause of heart…
- Trial name
- SAS-frailty (NCT02745314)
- Testing
- Frailty measurement, Comprehensive Geriatric Assessment
- Where
- Spain
- Volunteers
- 605 people
- Sponsor
- Hospital de Meixoeiro
Amyloidosis Cardiac, Aortic Stenosis, Severe
Analysis of Calcium Score of Severe Aortic Stenosis in Patients With and Without Cardiac Amyloidosis (CAUSATIVE Study)
The concomitant presence of cardiac amyloidosis (CA) in patients with aortic stenosis (AS) may challenge the estimation of stenosis degree.
- Trial name
- CAUSATIVE (NCT06066632)
- Where
- Italy
- Volunteers
- 480 people
- Sponsor
- University Hospital of Ferrara
Severe Symptomatic Aortic Stenosis
Evaluation of Length of Stay After TF-TAVI
Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the first-in-man TAVI performed in 2002.
- Trial name
- FAST-TAVI (NCT02956915)
- Testing
- Transfemoral Transcatheter aortic valve implantation
- Where
- 5 sites in France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Rouen
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
- Trial name
- NCT02862600
- Testing
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Heart Metabolics Limited
Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome
Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
Acquired Von Willebrand disease (type 2A) has been described in patients with severe aortic stenosis, the association of aortic stenosis and Digestive bleeding due to this phenomena has received the name of Heye´s syndrome.
- Conditions
- Acquired Von Willebrand Disease Secondary to Severe Aortic Stenosis, Heye´s Syndrome, Severe Aortic Stenosis
- Trial name
- NCT01994330
- Testing
- desmopressin
- Where
- Chile
- Volunteers
- 13 people
- Sponsor
- Pontificia Universidad Catolica de Chile
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
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
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
Critical Aortic Stenosis
The Nordic Aortic Valve Intervention Trial
A randomized clinical trial of transcatheter aortic valve implantation (TAVI) versus conventional surgical aortic valve replacement (SAVR) in patients older than 70 years of age suffering from severe aortic valve stenosis.
- Trial name
- NOTION (NCT01057173)
- Testing
- Transcatheter Aortic Valve Implantation, Surgical Aortic Valve Replacement
- Where
- 3 sites in Denmark, Sweden
- Volunteers
- 280 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
Transcatheter Aortic Valve Replacement, Coronary Artery Disease
Coronary Artery Disease Assessment Strategies in TAVI Patients
Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status.
- Conditions
- Transcatheter Aortic Valve Replacement, Coronary Artery Disease, Heart Disease Risk Factors
- Trial name
- CAT (NCT06559332)
- Testing
- Risk-based CAD management, Invasive coronary angiography
- Where
- Switzerland
- Volunteers
- 546 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Carotid Artery Plaque, Aortic Aneurysm
Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital LOS
the aim of this study is to determine whether an intraoperative optimization protocol using the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device in combination with intraoperative measurement of the…
- Conditions
- Carotid Artery Plaque, Aortic Aneurysm, Aneurysm
- Trial name
- NCT04913493
- Testing
- Cytocam-IDF
- Where
- Belgium
- Volunteers
- 22 people
- Sponsor
- Universitair Ziekenhuis Brussel