Clinical trials: Valvular Disease
Aortic Valve Stenosis, Valvular Heart Disease
CoreValve Advance-II Study: Prospective International Post-market Study
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
- Trial name
- Advance-II (NCT01624870)
- Where
- 9 sites in Belgium, Czechia and 4 more
- Volunteers
- 200 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Obesity
Effectiveness And Safety Of Oral Anticoagulants Among Obese Patients With Non-Valvular A-Fib In VA Patients With Medicare
The overall objective of this analysis is to understand patient characteristics, the use of treatment, and clinical outcomes among obese (overweight) and severely obese patients with non-valvular atrial fibrillation (NVAF) who…
- Conditions
- Atrial Fibrillation, Obesity, Anticoagulants
- Trial name
- NCT04681482
- Testing
- Apixaban
- Where
- United States
- Volunteers
- 107,383 people
- Sponsor
- Pfizer
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
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.
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
Comparative Effectiveness and Safety Between Warfarin and Dabigatran
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of…
- Trial name
- NCT03254134
- Testing
- Warfarin, Dabigatran
- Where
- Japan
- Volunteers
- 22,490 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin
The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048) administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with non-valvular atrial fibrillation (paroxysmal…
- Trial name
- NCT01136408
- Testing
- Dabigatran etexilate, Warfarin
- Where
- 28 sites in Japan
- Volunteers
- 174 people
- Sponsor
- Boehringer Ingelheim
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
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
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
Atrial Fibrillation
A Prospective, Open Label Study Evaluating Two Management Strategies on Gastrointestinal Symptoms in Patients Newly on Treatment With Pradaxa for the Prevention of Stroke and Systemic Embolism With Non-valvular Atrial Fibrillation
This is a prospective and open label study that aims to enroll approximately 1200 patients with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of gastrointestinal symptoms (GIS) for at least…
- Trial name
- NCT01493557
- Testing
- pantoprazole, Pradaxa (dabigatran etexilate), Pradaxa, within 30 minutes after a meal
- Where
- 103 sites in United States, Canada
- Volunteers
- 1,067 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
Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion)
Some people can develop an abnormal heart beat known as "Atrial fibrillation" or "AF" that puts them at risk of developing clots in the heart.
- Trial name
- EMANATE (NCT02100228)
- Testing
- Apixaban, Parenteral heparin and/or oral Vitamin K antagonist
- Where
- 165 sites in United States, Belgium and 10 more
- Volunteers
- 1,500 people
- Sponsor
- Pfizer
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
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
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
Atrial Fibrillation
This Study Observes the Use of New Oral Anticoagulants (NOACs) in Patients With a Heart Rhythm Disorder in Spain
The primary objective of the study is to describe the usage of NOACs in patients with NVAF, in the hospital setting, based on the baseline characteristics at the time of first NOAC initiation.
- Trial name
- RE-CONOCE (NCT03285373)
- Testing
- NOAC
- Where
- 75 sites in Spain
- Volunteers
- 1,008 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
The study is a prospective, non-randomized, multi-center investigation to establish the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are…
- Trial name
- PINNACLE FLX (NCT02702271)
- Testing
- WATCHMAN FLX
- Where
- 29 sites in United States
- Volunteers
- 458 people
- Sponsor
- Boston Scientific Corporation
Critical Aortic Stenosis
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
- Trial name
- PARTNER (NCT00530894)
- Testing
- Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement, medical management and/or balloon aortic valvuloplasty
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 1,057 people
- Sponsor
- Edwards Lifesciences
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