Clinical trials: Stenosis, Aortic
Septal Hypertrophy, Obstructive Hypertrophic Cardiomyopathy
Use of Cryoenergy to Faciltate Myectomy in Hypertrophic Obstructive Cardiomyopathy: Comparison With the Classical Approach
In some patients, septal hypertrophy extends more distally, from the subaortic portion of the septum to the midventricular portion.
- Trial name
- NCT05726799
- Testing
- Cryo myectomy, Myectomy
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Michele De Bonis
HOCM, Hypertrophic Obstructive Cardiomyopathy, LVOTO - Left Ventricular Outflow Tract Obstruction
Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction
Patients with HOCM and severe LVOT obstruction can remain asymptomatic while significant cellular and structural changes of the heart (adverse remodeling) may occur preceding heart failure and rhythm disorders.
- Conditions
- HOCM, Hypertrophic Obstructive Cardiomyopathy, LVOTO - Left Ventricular Outflow Tract Obstruction, Remodeling, Ventricular
- Trial name
- RASTA (NCT04230551)
- Testing
- PTSMA
- Where
- 2 sites in Netherlands
- Volunteers
- 15 people
- Sponsor
- St. Antonius Hospital
Congenital Aortic Stenosis
Cardiac Imaging in Adults With Congenital Aortic Stenosis
The CAS study is a prospective observational cohort study investigating the effects of congenital aortic stenosis (ConAoS) on the left ventricular function and the prevalence, pattern and expanse of left ventricular hypertrophy…
- Trial name
- CAS (NCT05252351)
- Where
- Netherlands
- Volunteers
- 75 people
- Sponsor
- Erasmus Medical Center
Cardiac Amyloidosis, Aortic Stenosis
Aortic Stenosis and Cardiac Amyloidosis
The dual pathology of aortic stenosis (AS) and cardiac amyloidosis (CA) is increasingly recognized. Even tough efforts have been undertaken to bring cohorts together, the largest cohort of AS-ATTR to date is <50 patients.
- Trial name
- NCT06129331
- Testing
- Amyloid-specific treatment, No amyloid-specific treatment
- Where
- 2 sites in Austria, United Kingdom
- Volunteers
- 300 people
- Sponsor
- Medical University of Vienna
Aortic Valve Stenosis
Venus-Vitae Pivotal Study Smart-Align Study
The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.
- Trial name
- NCT05991271
- Testing
- Venus-Vitae Transcatheter Heart Valve System
- Volunteers
- 150 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Severe Symptomatic Aortic Stenosis
Change in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities
Change in coronary microcirculation and Fractional Flow Reserve after Transcatheter Aortic Valve Implantation in patients with concomitant coronary artery disease and severe aortic stenosis.
- Trial name
- NCT04663334
- Testing
- inverse myocardial remodeling
- Where
- France
- Volunteers
- 29 people
- Sponsor
- Nantes University Hospital
Aortic Stenosis
CAN3T - Canadian TAVI Triage Tool
The goal of this trial is to see if a tool that may reduce wait times will reduce bad outcomes in participants on the TAVI waitlist.
- Trial name
- CAN3T (NCT06551610)
- Testing
- Triage Tool
- Volunteers
- 5,060 people
- Sponsor
- Sunnybrook Health Sciences Centre
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
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
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
Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement
This trial is to compare the efficacy of NOAC(Novel Oral Anticoagulants) with edoxaban vs. dual antiplatelet therapy (DAPT) for prevention of leaflet thrombosis (documented by cardiac CT imaging) and cerebral embolization…
- Trial name
- ADAPT-TAVR (NCT03284827)
- Testing
- NOAC, DAPT
- Where
- 5 sites in Hong Kong, South Korea and 1 more
- Volunteers
- 235 people
- Sponsor
- Duk-Woo Park, MD
Hypertrophic Cardiomyopathy
3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is very common. The thickened heart muscle can disrupt the normal functioning of the heart's electrical system, resulting in fast or irregular heartbeats.
- Trial name
- 3D-CMH (NCT03550573)
- Testing
- CardioInsight™ Noninvasive 3D Mapping System
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hospices Civils de Lyon
Heart Valve Diseases, Aortic Valve Disease
Rapid Non-invasive Detection of Aortic Stenosis
Avicena is developing new non-invasive methods (hardware and software) for diagnosis of a variety of heart conditions. This study is designed to compare data obtained using Avicena's device, the Vivio, to data obtained from…
- Conditions
- Heart Valve Diseases, Aortic Valve Disease, Heart Murmurs
- Trial name
- NCT04024566
- Testing
- Vivio System
- Where
- United States
- Sponsor
- Ventric Health, LLC
Hypertrophic Obstructive Cardiomyopathy
First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation
Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.
- Trial name
- NCT04770142
- Testing
- TIRA catheter
- Where
- 9 sites in South Korea
- Volunteers
- 5 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Hyperglycemia, Aortic Valve Replacement
The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose
The overall research plan is to test the hypothesis that intraoperative treatment of hyperinsulinemic normoglycemic clamp (HNC) in cardiac surgical patients improves myocardial function and short-term outcomes compared with…
- Conditions
- Hyperglycemia, Aortic Valve Replacement, Aortic Stenosis, Cardiac Surgery
- Trial name
- NCT01187329
- Testing
- hyperinsulinemic normoglycemic clamp (HNC), control group
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- The Cleveland Clinic
Transcatheter Aortic Valve Replacement, Atrial Fibrillation New Onset
Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
Transcatheter aortic valve implantation (TAVI) is a well-established alternative to surgical aortic valve replacement for the treatment of patients with symptomatic severe aortic stenosis.
- Conditions
- Transcatheter Aortic Valve Replacement, Atrial Fibrillation New Onset, Pacemaker, Colchicine
- Trial name
- Co-STAR (NCT04870424)
- Testing
- Colchicine
- Where
- Switzerland
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Aneurysm, Aortic Aneurysm Abdominal
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral
- Trial name
- CLOSURE (NCT06918496)
- Testing
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Where
- 2 sites in Belgium, Poland
- Volunteers
- 60 people
- Sponsor
- Grena Biomed Limited
Aortic Stenosis
Feasibility Study of the transShield Embolic Protection System
The objective of this study is to evaluate the initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT06652841
- Testing
- transShield Embolic Protection System
- Where
- New Zealand
- Volunteers
- 2 people
- Sponsor
- TransAortic Medical, Inc.
Hypertrophic Cardiomyopathy, Hypertrophic Obstructive Cardiomyopathy
Hypertrophic Cardiomyopathy Registry, Biobank and Imaging Data Repository
The Hearts in Rhythm Organization (HiRO) is a national network of Canadian researchers/clinicians, working towards a better understanding of the rare genetic causes of sudden cardiac death (SCD).
- Conditions
- Hypertrophic Cardiomyopathy, Hypertrophic Obstructive Cardiomyopathy, Familial Hypertrophic Cardiomyopathy, Cardiomyopathies
- Trial name
- HiRO-HCM (NCT05100420)
- Where
- 17 sites in Canada
- Volunteers
- 2,000 people
- Sponsor
- Montreal Heart Institute
Aortic Valve Stenosis
To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation
- Trial name
- NCT04893603
- Testing
- Transcatheter Aortic Valve System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chengdu Silara Meditech Inc.
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