Clinical trials: Severe Valvular Disease
Severe Aortic Stenosis
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and 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 very high risk and high risk for aortic…
- Trial name
- NCT01531374
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 45 sites in United States
- Volunteers
- 2,777 people
- Sponsor
- Medtronic Cardiovascular
Non-valvular Atrial Fibrillation
Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment
To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients…
- Trial name
- NCT01857622
- Testing
- DU-176b 15mg, DU-176b 30mg, DU-176b 60mg
- Where
- Japan
- Volunteers
- 93 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
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
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
Disparities in Treatment of Aortic Valve Stenosis, Aortic Valve Stenosis
Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease
Common barriers to receiving appropriate guideline-driven care for patients with severe aortic stenosis include referral biases by primary care providers (lack of provider education), patient comorbidities (degree of fragility)…
- Trial name
- NCT04525937
- Testing
- Patient Questionnaire, Provider Questionnaire
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Minneapolis Heart Institute Foundation
Severe Symptomatic Aortic Stenosis
Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System
The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis
- Trial name
- Portico TA EU (NCT01742598)
- Testing
- Portico Transapical Aortic Valve System
- Where
- United Kingdom
- Sponsor
- Abbott Medical Devices
Heart Valve Diseases, Moderate to Severe Valve Disease in the Elderly
China Elderly Valve Disease Study III (China-DVD3 Study)
This study aims to conduct a second round of multicenter, prospective registry research targeting elderly patients with valvular heart disease, to understand the current status of interventions for patients with valvular heart…
- Trial name
- NCT07816146
- Where
- China
- Volunteers
- 6,612 people
- Sponsor
- Yongjian Wu, MD, PhD
Sleep Disordered Breathing, Valvular Regurgitation
Sleep-Disordered Breathing in Patients With Severe Valvular Regurgitation Undergoing Clip Procedure
In a prospective observational study, the investigators investigate the prevalence of sleep disordered breathing in patients with severe valvular regurgitation and the effect of using the minimal invasive Clip technique on sleep…
- Trial name
- ClipSDB (NCT03813511)
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
Mitral Regurgitation, Mitral Valve Disease
AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation.
- Trial name
- AHEAD (NCT03339115)
- Testing
- Cardiovalve Transfemoral Mitral Valve
- Where
- 11 sites in Germany, Greece and 1 more
- Volunteers
- 30 people
- Sponsor
- Cardiovalve Ltd.
Valvular Heart Diseases, Valvular Heart Disease Stenosis and Regurgitation
ECG and CXR for Predicting Cardiovascular Diseases
This retrospective multicenter cohort study aims to develop and validate an artificial intelligence model integrating electrocardiography (ECG) and chest radiography (CXR) to predict future progression of regurgitant valvular…
- Conditions
- Valvular Heart Diseases, Valvular Heart Disease Stenosis and Regurgitation, Regurgitation, Aortic Valve, Regurgitation, Mitral
- Trial name
- NCT07573852
- Where
- China
- Volunteers
- 116,380 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
Mitral Regurgitation (MR), Moderate or Severe Aortic Stenosis (AS) (Mean Pressure Gradient ≥ 20 mm Hg or Aortic Valve Area ≤ 1.5 cm2)
Impact of Automatic Prompts in Echocardiographic Reports on Referral to Cardiology
Echo Prompts study is a multi-center randomized controlled study to evaluate the impact of automatic prompts added to the conclusion of the echocardiographic reports of patient diagnosed with significant VHD 1) suggesting…
- Trial name
- Echo Prompts (NCT06816888)
- Testing
- No Prompt, Prompt 1, Prompt 2
- Where
- Canada
- Volunteers
- 300 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Atrial Fibrillation, Intracardiac Thrombus
Response of Intracardiac Thrombus to Anticoagulants in Patients With Non-valvular Atrial Fibrillation (LYSIS)
This study aims to analyze changes in the immune status, metabolic status, and host microbiome community structure in non-valvular atrial fibrillation patients with intracardiac thrombus.
- Trial name
- LYSIS (NCT06141538)
- Testing
- Observational; No Interventions were given.
- Where
- China
- Volunteers
- 500 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Aortic Valve Stenosis, Cardiovascular Diseases
Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis
A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic valve replacement in patients 75 years of age or younger suffering from severe aortic valve stenosis.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases
- Trial name
- NOTION-2 (NCT02825134)
- Testing
- Transcatheter aortic valve replacement, Surgical aortic valve replacement
- Where
- 9 sites in Denmark, Finland and 3 more
- Volunteers
- 376 people
- Sponsor
- Ole De Backer
Atrial Fibrillation
Edoxaban and Frailty in Senior Individuals
Edoxaban, has shown in clinical registration trials a significant reduction of major bleeding compared to warfarin, especially in elderly patients.
- Trial name
- ESCAPE (NCT03524924)
- Where
- Italy
- Volunteers
- 180 people
- Sponsor
- University of Padova
Atrial Fibrillation, Ischemic Stroke
Direct Oral Anticoagulants in Patients With Atrial Fibrillation (DOACs vs DOACs)
The purpose of this study is to assess safety and effectiveness of direct oral anticoagulants (DOACs) for stroke prevention in patients with non-valvular atrial fibrillation (AF).
- Conditions
- Atrial Fibrillation, Ischemic Stroke, Systemic Embolization, Major Bleed
- Trial name
- NCT03568916
- Testing
- Apixaban (ATC B01AF02), Dabigatran (ATC B01AE07), Rivaroxaban (ATC B01AF01)
- Where
- Canada
- Volunteers
- 227,579 people
- Sponsor
- Canadian Network for Observational Drug Effect Studies, CNODES
Mitral Annulus Calcification, Rheumatic Heart Disease
Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE
Mitral stenosis (MS) is a heavily symptomatic valvular heart disease. Common causes of MS included chronic rheumatic heart disease (CRHD) and mitral annular calcification (MAC).
- Trial name
- SMARTMAC (NCT06952374)
- Testing
- SmartWave Lithotripsy balloon
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Cardiogenic Shock, Myocardial Infarction (MI)
BEAT-SHOCK Registry
This regulation defines the purpose, the operational processes, and the organization of the registry BEAT-SHOCK (Basel Evaluation of Acute Therapy in cardiogenic SHOCK).
- Conditions
- Cardiogenic Shock, Myocardial Infarction (MI), Fulminant Myocarditis, Acute Decompensated Heart Failure
- Trial name
- BEAT-SHOCK (NCT07643610)
- Testing
- no internvention
- Where
- Switzerland
- Volunteers
- 8,000 people
- Sponsor
- University Hospital, Basel, Switzerland
Aortic Valve Stenosis
Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis
The primary objective of the present trial is to demonstrate the effectiveness and safety of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects deemed difficult for surgical operation.
- Trial name
- NCT01437098
- Testing
- MDT-2111 CoreValve for TAVI
- Where
- 4 sites in Japan
- Volunteers
- 55 people
- Sponsor
- Medtronic Cardiovascular
Severe Aortic Stenosis
Safety and Efficacy of SYM-SV/DS-002 in Patients With Severe Aortic Stenosis
Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis
- Trial name
- NCT03004599
- Testing
- SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System
- Where
- 5 sites in Japan
- Volunteers
- 11 people
- Sponsor
- Medico's Hirata Inc.
Atrial Fibrillation
Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula.
- Trial name
- NCT01896297
- Testing
- Pradaxa, dabigatran etexilate
- Where
- 26 sites in United States
- Volunteers
- 63 people
- Sponsor
- Boehringer Ingelheim