Clinical trials: Aortic Valve Disease
Coronary Artery Disease, Aortic Stenosis, Severe
NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation
The aim of the IMPACTavi prospective cohort study is to test feasibility and safety of clinically indicated intravascular coronary imaging with NIRS-IVUS in addition to routine coronary angiography in patients scheduled for TAVI…
- Trial name
- IMPACTavi (NCT04976062)
- Testing
- Combined near-infrared spectroscopy and intravascular ultrasound imaging (NIRS-IVUS)
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 150 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Valve Insufficiency, Aortic Aneurysm
Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root. CAVIAAR
The primary objective of the CAVIAAR study is to prove that aortic valve sparing for patients with aortic root aneurysms and/or dystrophic aortic insufficiency is associated with a 45% increase of 3 years-survival rate without…
- Trial name
- CAVIAAR (NCT00478803)
- Testing
- Remodeling procedure associated with a subvalvular aortic ring or double sub and supra-valvular aortic annuloplasty, Mechanical valve replacement (isolated or composite valve and graft replacement); actual surgical standard for dystrophic aortic roots
- Where
- France
- Volunteers
- 245 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aortic Valve Stenosis, Symptomatic Aortic Stenosis
Structured Shared Decision Making for Patients Undergoing SAVR or TAVR
Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk.
- Trial name
- TOGETHER (NCT05711186)
- Testing
- Structured SDM, Usual Care
- Where
- 2 sites in Switzerland
- Volunteers
- 140 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Heart Failure, Aortic Stenosis
The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis
The role of cardiac mechanics, circulating biomarkers and frailty in predicting outcomes in patients with aortic stenosis after aortic valve replacement (SCRABLES -The 2-Parts Study) Part I: Observational study to characterize…
- Trial name
- SCRABLES (NCT02856620)
- Testing
- Observational only
- Where
- Canada
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Christine Henri
Coronary Disease, Aortic Valve Stenosis
Quantitative Measurement of Myocardial Perfusion by Cardiac CT in Patients
It is a common understanding that patients with coronary heart disease are suffering, among others, from reduced myocardial perfusion.
- Trial name
- CCT/MPERF (NCT02361996)
- Where
- 3 sites in Austria, Russia and 1 more
- Volunteers
- 690 people
- Sponsor
- Bakulev Scientific Center of Cardiovascular Surgery
Aortic Stenosis, Aortic Regurgitation
Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease
This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices…
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Mitral Regurgitation, Tricuspid Regurgitation
- Trial name
- NCT07605624
- Testing
- Transcatheter Aortic Valve Replacement, Transcatheter Edge-to-Edge Repair, Transcatheter Tricuspid Valve Annuloplasty
- Where
- China
- Volunteers
- 5,500 people
- Sponsor
- Beijing Anzhen Hospital
Williams Syndrome, Cardiovascular Disease
WS-SAVE Study (Williams Syndrome Skin and Vessel Elasticity Study)
Background: Williams Syndrome (WS) is a genetic disorder. People with WS have less of a protein that allows parts of the body to stretch than other individuals.
- Conditions
- Williams Syndrome, Cardiovascular Disease, Multisystem Developmental Disorder, Elastin Gene Deletion
- Trial name
- NCT02692846
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Valve Stenosis
First-in-Human (FIH) Study on the Feasibility and Safety of the TaviPilot Augmented Reality Guidance Software
The trial aims to evaluate the feasibility and safety of Caranx Medical TAVIPILOT augmented reality guidance software during Transcatheter Aortic Valve Replacement Procedures.
- Trial name
- NCT07043075
- Testing
- TAVR using a guidance software
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
Aortic Regurgitation
Performance of Currently Available traNscaTHEter Aortic Valve Platforms in Inoperable Patients With Pure Aortic regurgitatiON of a Native Valve. The PANTHEON International Project.
To investigate the performance of currently available THVs in terms of safety and efficacy To evaluate potential predictors of THV embolization or migration (TVEM) To assess the impact of TVEM on prognosis
- Trial name
- PANTHEON (NCT05319171)
- Testing
- TAVR
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Policlinico S. Donato
Periodontitis, Heart Valve Disease
Effect of Preoperative Periodontal Treatment on Postoperative Infection and Mortality After Aortic and Mitral Valve Surgery
This retrospective observational study aims to evaluate the effect of preoperative periodontal treatment on postoperative infection and mortality in patients undergoing aortic and mitral valve surgery.
- Conditions
- Periodontitis, Heart Valve Disease, Postoperative Infection, Cardiovascular Disease
- Trial name
- Perio-CVS (NCT07626801)
- Where
- Turkey (Türkiye)
- Volunteers
- 200 people
- Sponsor
- Istanbul University - Cerrahpasa
Coronary Artery Disease, Aortic Valve Stenosis
MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
MiECS is one of the largest multicentre randomised controlled trials on extracorporeal circulation conducted under the auspices of Minimal Invasive Extracorporeal Technologies International Society (MiECTiS).
- Conditions
- Coronary Artery Disease, Aortic Valve Stenosis, Extracorporeal Circulation; Complications
- Trial name
- MiECS (NCT05487612)
- Testing
- Minimal Invasive Extracorporeal Circulation, Conventional cardiopulmonary bypass
- Where
- 13 sites in Canada, Germany and 4 more
- Volunteers
- 1,300 people
- Sponsor
- Aristotle University Of Thessaloniki
Cardiovascular Diseases, Heart Failure
Longitudinal Validation of CIRC Technologies
Cardiovascular disease is the leading cause of death worldwide. Advanced cardiovascular imaging using Magnetic Resonance Imaging (MRI) has proven to be effective in providing gold standard myocardial tissue characterization.
- Conditions
- Cardiovascular Diseases, Heart Failure, Ischemic Heart Disease, Non-ischemic Cardiomyopathy
- Trial name
- NCT07081711
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Aortic Valve Stenosis
VitaFlow LIBERTY Europe
This is a prospective, single-arm, multi-center, observational, post-market clinical investigation to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the…
- Trial name
- NCT06535659
- Testing
- VitaFlow Liberty™ Transcatheter Aortic Valve System
- Where
- 9 sites in Ireland, Italy and 3 more
- Volunteers
- 222 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Aortic Valve Stenosis With Insufficiency, Aortic Valve Stenosis
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.
- Trial name
- TRITON (NCT01445171)
- Testing
- Aortic Valve Replacement with EDWARDS INTUITY Valve System
- Where
- 6 sites in Austria, Germany
- Volunteers
- 295 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy
Echocardiography-guided Percutaneous Septal Radiofrequency Ablation for Obstructive HCM After Alcohol Septal Ablation
After alcohol ablation, some HOCM patients have serious clinical symptoms and adverse complications, and need to undergo invasive surgery again when adequate drug therapy is not effective or cannot tolerate the side effects of…
- Trial name
- HCM (NCT06496633)
- Testing
- Percutaneous Intramyocardial Septal Radiofrequency Ablation
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Xijing Hospital
Stroke
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).
- Trial name
- PROTECTED TAVR (NCT04149535)
- Testing
- Sentinel® Cerebral Protection System
- Where
- 57 sites in United States, Australia and 4 more
- Volunteers
- 3,000 people
- Sponsor
- Boston Scientific Corporation
Cerebral Stroke, Aortic Valve Disease
Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement
The purpose of this study is to compare the incidence of silent and apparent cerebral embolism between conventional and minimal-invasive transfemoral aortic valve repair.
- Trial name
- NCT00883285
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- University Hospital, Bonn
Aortic Stenosis
Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis
Transcatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk elderly with aortic stenosis, however, mortality remains high.
- Trial name
- TAVR-FRAILTY (NCT02597985)
- Testing
- Prehabilitation, Usual Care
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Mayo Clinic
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 DISEASES, Calcification; Heart
Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity
This is a prospective study that aims to develop clinical calculators that will report on the underlying rate of aortic valve calcification.
- Trial name
- NCT07819344
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
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