Clinical trials: Valvular Heart Disease Patients
Atrial Fibrillation, Stroke
Patient Convenience Study (RE-SONANCE)
The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its…
- Trial name
- NCT02684981
- Where
- 12 sites in Austria, Bulgaria and 10 more
- Volunteers
- 9,472 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Xarelto on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Treatment-naïve Asian Patients With Non-valvular Atrial Fibrillation
The purpose of the study is to collect additional information of Xarelto treatment in routine clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a prophylactic treatment against stroke and…
- Trial name
- XaMINA (NCT03284762)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 2 sites in South Korea, Taiwan
- Volunteers
- 1,216 people
- Sponsor
- Bayer
Heart Valve Diseases
Dabigatran Etexilate in Patients With Mechanical Heart Valves
To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.
- Trial name
- RE-ALIGN (NCT01452347)
- Testing
- warfarin 1mg, dabigatran etexilate intermediate dose, dabigatran etexilate low dose
- Where
- 40 sites in Belgium, Canada and 8 more
- Volunteers
- 328 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE)
This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratification score of 1 or greater.
- Trial name
- EVOLVE (NCT01196897)
- Testing
- WATCHMAN LAA Closure Technology (Gen 4.0)
- Where
- 3 sites in Czechia, Germany
- Volunteers
- 69 people
- Sponsor
- Boston Scientific Corporation
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
Atrial Fibrillation
Atrial Fibrillation Patient Preference Study
The main research question of this patient survey is to assess AF patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (VKA or NOACs and, in case of…
- Trial name
- PRiSMA-AF (NCT02611635)
- Testing
- VKA: Warfarin (Waran), NOAC: Rivaroxaban (Xarelto, BAY59-7939), NOAC: Dabigatran etexilate
- Where
- Sweden
- Volunteers
- 382 people
- Sponsor
- Bayer
Atrial Fibrillation
Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants
The purpose of this study is to compare the risk of major bleeding event among nonvalvular atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.
- Trial name
- NCT02754154
- Testing
- Warfarin, Apixaban, Dabigatran
- Volunteers
- 321,182 people
- Sponsor
- Bristol-Myers Squibb
Atrial Fibrillation
Burden of Ischemic Stroke and Intake of Oral Anticoagulants in Patients With Atrial Fibrillation in the UK Primary Care
This study will characterize patients with ischemic stroke, a condition which occurs when a vessel supplying blood to the brain is obstructed, and a subpopulation of patients with irregular and often rapid heart rate (atrial…
- Trial name
- BEST-AF (NCT04099238)
- Testing
- Oral anticoagulant
- Where
- United Kingdom
- Volunteers
- 3,739 people
- Sponsor
- Bayer
Aortic Stenosis
ACURATE Neo™ TA Delivery System in Patient With Severe Aortic Stenosis
The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System.
- Trial name
- NCT02950428
- Testing
- ACURATE neo™TA Delivery System
- Where
- 7 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Symetis SA
Non-valvular Atrial Fibrillation (AF)
Vortosiran in Atrial Fibrillation
This is a randomised, actively controlled Phase IIb trial to evaluate the safety and pharmacodynamics (PD) of two blinded doses of subcutaneously administered vortosiran and open-label apixaban in patients with AF.
- Trial name
- NCT07870889
- Testing
- Vortosiran, Apixaban
- Where
- 15 sites in Denmark, Norway and 2 more
- Volunteers
- 150 people
- Sponsor
- Ribocure Pharmaceuticals AB
Atrial Fibrillation
Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication
National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues for stroke prevention…
- Trial name
- SAFARI (NCT01805531)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- France
- Volunteers
- 411 people
- Sponsor
- Bayer
Parkinson Disease
Observational Study of Pergolide Mesylate and Cardiac Valvulopathy
The primary objective of this study is to estimate the incidence of new-onset valvulopathy, determined by baseline and follow-up echocardiograms, in patients with Parkinson's Disease who are receiving pergolide as second-line…
- Trial name
- NCT00311532
- Where
- 14 sites in Belgium, France and 2 more
- Volunteers
- 200 people
- Sponsor
- Eli Lilly and Company
Atrial Fibrillation
Anticoagulation Preference by AF Patients Study
The main research question of this patient survey is to assess AF (Atrial Fibrillation) patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (Vitamin…
- Trial name
- PRiSMA-AF (NCT02607371)
- Testing
- VKAs, NOACs including Rivaroxaban (Xarelto, BAY59-7939), Edoxaban
- Where
- Switzerland
- Volunteers
- 198 people
- Sponsor
- Bayer
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
Mitral Regurgitation, Heart Failure
Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus
- Trial name
- PTOLEMY2Canada (NCT00815386)
- Testing
- Percutaneous transvenous mitral annuloplasty
- Where
- 3 sites in Canada
- Volunteers
- 20 people
- Sponsor
- Viacor
Pulmonary Regurgitation
Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts
A prospective, non-randomized multi-center clinical investigation of the Venus P-Valve™ for the treatment of pulmonary regurgitation with or without stenosis in patient with native outflow tracts.
- Trial name
- NCT02846753
- Testing
- trans catheter heart valve replacement
- Volunteers
- 84 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Aortic Stenosis Senile, Aortic Stenosis Symptomatic
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis
The objective of this pivotal, prospective, multicenter, single-arm clinical trial is to evaluate the safety and clinical performance of the Next-Generation INOVARE® SAFESYNC Bioprosthetic Heart Valve, implanted via a…
- Conditions
- Aortic Stenosis Senile, Aortic Stenosis Symptomatic, Aortic Stenosis
- Trial name
- SAFESYNC NG (NCT07806409)
- Testing
- INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve
- Volunteers
- 40 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
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
Mitral Valve Regurgitation
Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study
Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty Ring.
- Trial name
- MAARS (NCT00554151)
- Testing
- Adjustable Annuloplasty Ring
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices