Clinical trials: Valvular Disease
Tricuspid Regurgitation, Tricuspid Valve Disease
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders
- Trial name
- VISTA (NCT05797519)
- Testing
- VDyne Transcatheter Tricuspid Valve Replacement System
- Where
- 21 sites in Australia, Austria and 9 more
- Volunteers
- 120 people
- Sponsor
- VDyne, Inc.
Atrial Fibrillation
Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population
- Trial name
- NCT00448214
- Testing
- YM150, warfarin
- Where
- 18 sites in Australia, Hong Kong and 8 more
- Volunteers
- 448 people
- Sponsor
- Astellas Pharma Inc
Atrial Fibrillation
This Study Observes the Usage of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) in Elderly Patients With a Heart Rhythm Disorder in Spain
This is an observational, multicenter and cross-sectional study in Non-valvular atrial fibrillation (NVAF) elderly patients currently on Non-vitamin K antagonist oral anticoagulant (NOAC) treatment for their stroke prevention.
- Trial name
- NCT03993119
- Testing
- Non-vitamin K antagonist oral anticoagulant
- Where
- 45 sites in Spain
- Volunteers
- 500 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)
1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12 months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for definitive treatment discontinuation will be…
- Trial name
- NCT02240667
- Testing
- Dabigatran etexilate, Vitamin K antagonists
- Where
- Germany
- Volunteers
- 1,506 people
- Sponsor
- Boehringer Ingelheim
Aortic Valve Stenosis
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, and crimper accessories.
- Trial name
- PREVAIL-20J (NCT01419015)
- Testing
- SAPIEN XT NovaFlex delivery system
- Where
- 4 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Edwards Lifesciences
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.
Atrial Fibrillation, Stroke
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.
- Trial name
- NCT00262600
- Testing
- warfarin, Dabigatran dose 1, Dabigatran dose 2
- Where
- 984 sites in United States, Argentina and 42 more
- Volunteers
- 18,113 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
A Study Using Electronic Health Information to Learn About Rivaroxaban Compared to Warfarin in Participants With Non-valvular Atrial Fibrillation (NVAF) and Diabetes
In people with type 2 diabetes, the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels.
- Trial name
- RIVA-DM (NCT04509193)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Warfarin
- Where
- United States
- Volunteers
- 116,049 people
- Sponsor
- Bayer
Heart Valve Diseases
Methods Study to Evaluate Use of Cardiac Ultrasound to Assess Heart Valve Abnormality in People.
Methods study to evaluate use of cardiac ultrasound to assess heart valve abnormality in people.
- Trial name
- NCT00359489
- Testing
- cardiac echosonography
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer
Atrial Fibrillation
Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia
This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.
- Trial name
- XANAP (NCT01750788)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 11 sites in Hong Kong, India and 9 more
- Volunteers
- 2,297 people
- Sponsor
- Bayer
Atrial Fibrillation, Stroke
DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation
This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis.
- Trial name
- NCT00806624
- Testing
- DU-176b tablets, Warfarin tablets
- Where
- 4 sites in China, Singapore and 2 more
- Volunteers
- 234 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Atrial Fibrillation
Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)
In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo Hong Kong proposed this non-interventional study (NIS) to gain insight into the safety of…
- Trial name
- NCT03247582
- Testing
- Edoxaban
- Where
- 4 sites in Hong Kong
- Volunteers
- 234 people
- Sponsor
- Daiichi Sankyo Hong Kong Ltd., a Daiichi Sankyo Company
Atrial Fibrillation
The Effectiveness and Safety of Apixaban in NVAF Patients With History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study
Old age, less body weight and deteriorated renal function are significant clinical factors for the outcomes of atrial fibrillation- so called 'fragile'- and these are common risk factors in osteoporosis and fracture.
- Trial name
- NCT04198844
- Testing
- warfarin, apixaban
- Where
- South Korea
- Sponsor
- Pfizer
Atrial Fibrillation
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients…
- Trial name
- OPTION (NCT03795298)
- Testing
- WATCHMAN FLX Implant, Market-approved OAC
- Where
- 114 sites in United States, Australia and 8 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Treatment Pattern of Oral Anticoagulants (OAC) in Japan
1. To understand the treatment patterns of OACs and baseline patient characteristics of Japanese Non-Valvular Atrial Fibrillation (NVAF) patients 2.
- Trial name
- NCT02982863
- Where
- Japan
- Volunteers
- 48,696 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
This Study Uses the SITS Registry to Find Out When Patients With a Heart Rhythm Disorder (Atrial Fibrillation) Start Treatment With Dabigatran After They Had a Stroke
This is an observational study in patients with non-valvular atrial fibrillation (NVAF) presenting to the hospital with a first acute ischemic stroke based on existing data recorded in the SITS International Registry (located in…
- Trial name
- NCT03258645
- Testing
- Dabigatran
- Where
- Sweden
- Volunteers
- 1,489 people
- Sponsor
- Boehringer Ingelheim
Aortic Stenosis, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
A Study to Evaluate Effectiveness and Safety of Edoxaban in Patients 80 Years of Age or Older With Nonvalvular Atrial Fibrillation
Non-valvular atrial fibrillation (NVAF) increases the risk of stroke by three- to five-fold, especially in elderly patients, creating a huge burden on medical system as well as a negative impact on patients' lives.
- Trial name
- SILVERCARE_AF (NCT05804747)
- Testing
- Edoxaban
- Where
- 33 sites in South Korea
- Volunteers
- 1,204 people
- Sponsor
- Daiichi Sankyo
Atrial Fibrillation, Percutaneous Coronary Intervention
Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate…
- Trial name
- NCT02164864
- Testing
- Dabigatran Etexilate 110mg, Warfarin 3mg, Aspirin
- Where
- 421 sites in United States, Argentina and 39 more
- Volunteers
- 2,725 people
- Sponsor
- Boehringer Ingelheim
Stroke, Prevention and Control
An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With Non-valvular Atrial Fibrillation With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers
This is a retrospective observational study to describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism, who at least…
- Conditions
- Stroke, Prevention and Control, Atrial Fibrillation
- Trial name
- BRONCE-AP (NCT02559232)
- Testing
- Direct Oral Anticoagulant (DOAC)
- Where
- Spain
- Volunteers
- 247 people
- Sponsor
- Bayer