Clinical trials: Valve Disease, Aortic
Aortic Stenosis, TAVI
Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis（ECHO-TAVR）
Aortic stenosis (AS) is a common valvular heart disease whose prevalence increases markedly with age-approximately 2-4% in individuals aged 65 years and older, and up to 3.4% for severe AS in those over 75.
- Conditions
- Aortic Stenosis, TAVI, TAVI(Transcatheter Aortic Valve Implantation)
- Trial name
- ECHO-TAVR (NCT07317804)
- Testing
- Echocardiographic guidance, Fluoroscopic guidance
- Where
- China
- Volunteers
- 212 people
- Sponsor
- China National Center for Cardiovascular Diseases
Aortic Valve Disease, Mitral Valve Disease
The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
The goal of this open, prospective, multicenter study is analyze long-term outcomes of aortic/mitral valve replacement using the "UniLine" bioprosthesis in patients with acquired aortic or mitral valve diseases.
- Trial name
- Uniline (NCT06025149)
- Where
- Russia
- Volunteers
- 300 people
- Sponsor
- Closed Joint-Stock Company NeoCor
Aortic Regurgitation Disease
Artificial Intelligence in Aortic Regurgitation
This research project aims to develop and validate a tool that uses artificial intelligence (AI) to automatically detect and quantify aortic regurgitation (AR).
- Trial name
- NCT07486271
- Testing
- AI-Assisted Group, Manual measurement group
- Where
- Hong Kong
- Volunteers
- 540 people
- Sponsor
- Chinese University of Hong Kong
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
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT00636987
- Testing
- Biocor and Biocor Supra valves
- Where
- 17 sites in United States
- Volunteers
- 297 people
- Sponsor
- Abbott Medical Devices
Postoperative Delirium
Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation
Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive characteristics: they are old, frail, with several co-morbidities and take multiple medications.
- Trial name
- NCT02585128
- Testing
- Delirium assessment, MMSE (Mini Mental State Examination), Barthel index
- Where
- Switzerland
- Volunteers
- 201 people
- Sponsor
- Cardiocentro Ticino
TAVI(Transcatheter Aortic Valve Implantation), Aortic Valve Disease
SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation
The goal of this observational study is to document which LV-guidewires are used during a TAVI (Transcatheter Aortic Valve Implantation) procedure and how their different functions perform.
- Trial name
- SAPPHIRE (NCT07366671)
- Where
- Netherlands
- Volunteers
- 300 people
- Sponsor
- dr Pim A.L. Tonino
Obstructive Hypertrophic Cardiomyopathy
Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy
This is a prospective, single-center, single-arm clinical study. All patients were diagnosed with obstructive hypertrophic cardiomyopathy, and only subjects who met the instrument indications of this study were treated.
- Trial name
- NCT06211595
- Testing
- DragonFire Transcatheter Myocardial Radiofrequency Ablation System
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Cardiac Surgery, Coronary Artery Bypass
An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery
This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after cardiac surgery.
- Conditions
- Cardiac Surgery, Coronary Artery Bypass, Aortic Aneurysm, Valve Surgery
- Trial name
- NCT01256372
- Testing
- AP214
- Where
- Denmark
- Volunteers
- 77 people
- Sponsor
- Action Pharma A/S
Aortic Valve Stenosis
Non-Contrast Magnetic Resonance Angiography Assessment of Patients Referred for Transcatheter Aortic Valve Implantation
The overall objective of this proposal is to examine the feasibility and accuracy of non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals referred for transcatheter aortic valve implantation…
- Trial name
- NCT02007967
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Michigan
Aortic Valve Disease, Aortic Valve Stenosis
Re-hospitalisation After Transcatheter Aortic Valve Implantation
The goal of this study is to investigate whether patient-tailored follow-up for patients treated with transcatheter aortic valve implantation (TAVI) can prevent re-hospitalisation and improve quality of life compared with the…
- Trial name
- HOSPITAVI (NCT05670041)
- Testing
- Intensified follow-up
- Where
- Denmark
- Volunteers
- 500 people
- Sponsor
- Ole De Backer
Non-ischemic Cardiomyopathy, DCM - Dilated Cardiomyopathy
DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies
The DZHK TranslatiOnal Registry for CardiomyopatHies (DZHK TORCH) represents a unique resource of clinical data and high quality biological samples to enable innovative clinical and molecular studies on cardiomyopathies (CMP).
- Conditions
- Non-ischemic Cardiomyopathy, DCM - Dilated Cardiomyopathy, HCM - Hypertrophic Cardiomyopathy, HOCM - Hypertrophic Obstructive Cardiomyopathy
- Trial name
- TORCH-Plus (NCT04265040)
- Where
- Germany
- Volunteers
- 2,040 people
- Sponsor
- University Hospital Heidelberg
Heart Diseases
Carotid Filtration During Endovascular Aortic Valve Implantation
This study was designed as a First In Man (FIM) trial to evaluate the feasibility and technical capability of the Claret CE Pro System in delivering two embolic filters to the brachiocephalic artery and the left common carotid…
- Trial name
- NCT01484249
- Testing
- CE Pro System
- Volunteers
- 38 people
- Sponsor
- Claret Medical
Hypertrophic Cardiomyopathy (HCM)
A Real-world HCM-cohort Trial
Hypertrophic cardiomyopathy (HCM) is a genetically mediated myocardial disease predominantly caused by pathogenic mutations in sarcomeric protein genes and characterized by asymmetric left ventricular hypertrophy.
- Trial name
- NCT07638033
- Testing
- Standard of care
- Where
- China
- Volunteers
- 3,000 people
- Sponsor
- Xijing Hospital
Hypertrophic Cardiomyopathy, Mechanical Hyper-synchronicity
Hyper-synchronicity in Hypertrophic Cardiomyopathy (HCM) : Description, Mechanism and Origin With a Multi-imaging Approach to Predict Dual Chamber Pacing Response
Hypertrophic cardiomyopathy (HCM) is a common genetic cardiovascular disease. Outflow-tract gradient of 30 mmHg or more under resting conditions is an independent determinant of symptoms of progressive heart failure and death.
- Trial name
- HSYNC (NCT02559726)
- Testing
- Echocardiography (TEE), Magnetic resonance imaging (MRI) with gadolinium enhancement, Magnetic resonance imaging (MRI) without gadolinium enhancement
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bordeaux
Obstructive Hypertrophic Cardiomyopathy
An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM
This is an open-label extension study of China cohort in the phase 3 study (CY 6031) of aficamten for the treatment of obstructive HCM (oHCM) to collect long-term safety and tolerability data, including assessments of cardiac…
- Trial name
- NCT06116968
- Testing
- Aficamten
- Where
- 12 sites in China
- Volunteers
- 40 people
- Sponsor
- Corxel Pharmaceuticals
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Biological Collection for the Purpose of Exploring Genetic and Clinical-biological Factors Associated With Variability in Response to Mavacamten in the Treatment of Obstructive Hypertrophic Cardiomyopathy
The European Medicines Agency has required pre-treatment genotyping of CYP2C19 to determine the initial and maximum dosage, in order to avoid overexposure to mavacamten associated with a decrease in ventricular ejection fraction…
- Trial name
- MAVA PG (NCT07439952)
- Where
- 3 sites in France
- Volunteers
- 300 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cardiomyopathy, Hypertrophic Obstructive, Left Ventricular Outflow Tract Obstruction
A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
The purpose of this phase 2 open-label pilot study is to evaluate the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of MYK-461 in subjects with symptomatic HCM and LVOT obstruction aged 18-70…
- Trial name
- PIONEER-HCM (NCT02842242)
- Testing
- MYK-461
- Where
- 7 sites in United States
- Volunteers
- 21 people
- Sponsor
- MyoKardia, Inc.
Aortic Valve Disease, Artificial Heart Valves
Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis
The goal of this multicenter prospective cohort study is to evaluate the long-term safety and efficacy of clinical outcomes of aortic valve replacement using the "TiAra" prosthesis with or without concomitant procedures.
- Trial name
- TiAra (NCT05998694)
- Where
- Russia
- Volunteers
- 2,000 people
- Sponsor
- Closed Joint-Stock Company NeoCor
Aortic Stenosis
Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
To establish the safety and effectiveness of surgical aortic valve replacement (SAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk.
- Trial name
- AMETHYST (NCT06924151)
- Testing
- surgical aortic valve replacement, Transcatheter aortic valve replacement
- Where
- 37 sites in Japan
- Volunteers
- 450 people
- Sponsor
- Osaka University
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