Clinical trials: Valvular Diseases
Atrial Fibrillation
Assessment of the Effectiveness and Safety Outcome in Patients With Atrial Fibrillation Treated by Apixaban in Belgium
The PROVECT study is a retrospective, multicentre study assessing the effectiveness and the safety outcomes in patients with non-valvular atrial fibrillation (NVAF) treated by apixaban between 2015 and 2019 (5 years follow up).
- Trial name
- PROVECT (NCT05116267)
- Where
- Belgium
- Sponsor
- Pfizer
Symptomatic Aortic Stenosis
First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System
The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe…
- Trial name
- SJM TAVI FIH (NCT01487330)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR Pivotal Trial
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart.
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- ALIGN-AR (NCT04415047)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 30 sites in United States
- Volunteers
- 180 people
- Sponsor
- JenaValve Technology, Inc.
Non-valvular Atrial Fibrillation (NVAF)
A Study to Learn Whether There Are Differences in the Kidney's Ability to Work Properly in Korean Patients With Non-valvular Atrial Fibrillation (Irregular and Often Rapid Heartbeat Not Caused by a Heart Valve Problem) Treated With Rivaroxaban as Compared to Those Treated With Warfarin
This is an observational study in which data collected from the past of patients with non-valvular atrial fibrillation (NVAF) is studied.
- Trial name
- RENOVATOR (NCT05022758)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Warfarin
- Where
- South Korea
- Volunteers
- 45,000 people
- Sponsor
- Bayer
Non-valvular Atrial Fibrillation
WAVECREST Post Market Clinical Follow-Up (PMCF) Study
The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in…
- Trial name
- NCT03204695
- Testing
- Percutaneous LAA Closure, Anticoagulation or Clopidogrel
- Where
- Belgium
- Volunteers
- 27 people
- Sponsor
- Coherex Medical
Symptomatic Aortic Stenosis
Portico TAVI Implant With Transfemoral Delivery System
The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
- Trial name
- NCT01493284
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- 14 sites in Australia, Denmark and 3 more
- Volunteers
- 222 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Hypertension
Validation Study of an Advanced Blood Pressure Monitor
The proposed clinical study aims to validate the effectiveness of the WPM04 blood pressure monitor developed by Withings as a diagnostic tool for cardiovascular disorders.
- Conditions
- Atrial Fibrillation, Hypertension, Valvular Heart Disease
- Trial name
- TALISMAN (NCT04030494)
- Testing
- BP measurement, AF detection, VHD detection
- Where
- France
- Volunteers
- 218 people
- Sponsor
- Withings
Stroke
Use of Direct Oral Anticoagulants in UK
Many people who suffer from irregular heartbeats (atrial fibrillation) which might cause stroke, need to take blood thinners to prevent it.
- Trial name
- NCT03119116
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Dabigatran, Apixaban
- Where
- United Kingdom
- Volunteers
- 31,336 people
- Sponsor
- Bayer
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT05902897
- Testing
- Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis.
- Where
- 3 sites in Brazil
- Volunteers
- 913 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Cerebral Stroke, Thrombosis, Deep Vein
A Study of Adverse Events and Suspected Adverse Drug Reactions in Patients Under Apixaban for Prevention of Stroke and Systemic Embolism With Non-Valvular Atrial Fibrillation and Venous Thromboembolic Events in Patients Who Have Undergone Elective Hip or Knee Replacement Surgery
To characterize and analyze the number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with Apixaban, according to therapeutic indications approved in Mexico.
- Conditions
- Cerebral Stroke, Thrombosis, Deep Vein, Pulmonary Embolism
- Trial name
- NCT03804125
- Sponsor
- Pfizer
Hypertension, Atrial Fibrillation
A Cross-sectional Study for the Determination of the Prevalence of Non-valvular Atrial Fibrillation Among Patients Diagnosed With Hypertension
Arterial hypertension has been recognized as a major causal factor for atrial fibrillation (AF), the most common sustained cardiac arrhythmia.
- Trial name
- REFINE HT (NCT02585076)
- Testing
- Standard of care
- Where
- Greece
- Volunteers
- 1,119 people
- Sponsor
- Bayer
Atrial Fibrillation
Late Phase 2 Study of DU-176b in Patients With Non-Valvular Atrial Fibrillation
The primary objective of this study is to compare the incidence of hemorrhagic events in patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus warfarin potassium (warfarin).
- Trial name
- NCT00829933
- Testing
- DU-176b tablets, Warfarin potassium tablets
- Where
- Japan
- Volunteers
- 536 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Atrial Fibrillation (Prevention of Stroke)
Real-Life Evidence on Stroke Prevention in SPAF
To obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF) in a real-life setting
- Trial name
- RELIEF (NCT02485873)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonists
- Where
- Germany
- Volunteers
- 8,607 people
- Sponsor
- Bayer
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
Atrial Fibrillation, Stroke
An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation
The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as…
- Conditions
- Atrial Fibrillation, Stroke, Embolism
- Trial name
- NCT00403767
- Testing
- Rivaroxaban, Warfarin
- Where
- 932 sites in United States, Argentina and 42 more
- Volunteers
- 14,269 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Atrial Fibrillation
Patient Characteristics, Treatment Patterns And Incidence Of Events (Discontinuation, Persistence, Key Primary Clinical Outcomes) In NVAF Patients Initiating OAC Therapy In Colombia
The study aim to assess demographic and clinical characteristics , treatment patterns and as exploratory analysis will descriptively assess the time to clinical events of NVAF patients treated with oral anticoagulants (OACs) in…
- Trial name
- NCT04234698
- Where
- Colombia
- Volunteers
- 2,076 people
- Sponsor
- Pfizer
Valvular Heart Disease, Aortic Valve Disease
Regent China Post-Market Clinical Follow-up Study
Regent China Post-Market Clinical Follow-Up (RC-PMCF): this clinical study is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population.
- Trial name
- NCT05330468
- Testing
- Abbott Mechanical Heart Valve (MHV) Regent™
- Where
- 5 sites in China
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Stroke
WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2
The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.
- Trial name
- WAVECREST2 (NCT03302494)
- Testing
- Coherex WaveCrest® Left Atrial Appendage Occlusion System, Watchman® LAA Closure Device
- Where
- 25 sites in United States, Australia
- Volunteers
- 248 people
- Sponsor
- Coherex Medical
Atrial Fibrillation
Belgian Real Life Non-interventional Study (NIS) on Xarelto in Non-valvular Atrial Fibrillation (AF) Patients Treated for the Prevention of Stroke and Systemic Embolism
The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with non-valvular AF treated with Xarelto…
- Trial name
- BOX-AF (NCT01855139)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Belgium
- Volunteers
- 106 people
- Sponsor
- Bayer
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