Clinical trials: Valvular Disease
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
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
Trial of Apixaban vs Warfarin in Reducing Rate of Cognitive Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Patients With Atrial Fibrillation
The investigators' central hypothesis is that in patients with atrial fibrillation, anticoagulation with Apixaban reduces the rate of decline in cognitive function, when compared to Warfarin.
- Trial name
- ARISTA (NCT03839355)
- Testing
- Apixaban, Warfarin
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Mayo Clinic
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
Aortic Stenosis
PERIGON Japan Trial
The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.
- Trial name
- NCT02686814
- Testing
- 17mm MDT-2215 aortic valve bioprosthesis
- Where
- 10 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Medtronic Cardiac Surgery
Aortic Valve Stenosis
PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), its transfemoral delivery system, and crimper…
- Trial name
- NCT00820599
- Testing
- Sapien XT™ transcatheter heart valve and delivery system
- Where
- 11 sites in Belgium, France and 2 more
- Volunteers
- 214 people
- Sponsor
- Edwards Lifesciences
Coronary Artery Disease, Valvular Heart Disease
Sugammadex Titration in Cardiac Surgery Patients
Sugammadex is frequently used to reverse the effects of neuromuscular blocking drugs. The recommended doses are 2 mg/kg or 4 mg/kg depending upon the depth of neuromuscular blockade.
- Conditions
- Coronary Artery Disease, Valvular Heart Disease, Aorta Disease, Heart Failure
- Trial name
- NCT05246397
- Testing
- Sugammadex administration
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Washington
Atrial Fibrillation
The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis
The purpose of this study is to assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in comparison to newly initiated rivaroxaban users and newly…
- Trial name
- NCT03026556
- Testing
- Dabigatran vs. Rivaroxaban, Dabigatran vs. Apixaban
- Where
- United States
- Volunteers
- 42,534 people
- Sponsor
- Boehringer Ingelheim
Dementia, Cognition Disorders
Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation
Patients will be screened at Intermountain Medical Center and at Intermountain-affiliated anticoagulation clinics in the Salt Lake City region. Patients with non-valvular atrial fibrillation will be considered for study.
- Conditions
- Dementia, Cognition Disorders, Cerebral Ischemic Events
- Trial name
- CAF (NCT03061006)
- Testing
- Dabigatran Etexilate, Warfarin
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Intermountain Health Care, Inc.
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.
Non-valvular Atrial Fibrillation (NVAF)
AMPLATZER™ Cardiac Plug Observational Post-Approval Study
The purpose of this study is to observe the safety and effectiveness of the AMPLATZER™ Cardiac Plug (ACP) device in Chinese population indicated for use of AMPLATZER™ Cardiac Plug after its market approval by China FDA (CFDA).
- Trial name
- ACP China (NCT02954237)
- Testing
- AMPLATZER™ Cardiac Plug
- Where
- 6 sites in China
- Volunteers
- 91 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis
The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for…
- Trial name
- NCT01634269
- Testing
- MDT-2111 TAVI 23 mm
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiovascular
Atrial Fibrillation
The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage
The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.
- Trial name
- NCT02043808
- Where
- United States
- Volunteers
- 25,586 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
Stroke
AMPLATZER™ Amulet™ LAA Occluder Trial
The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial…
- Trial name
- Amulet IDE (NCT02879448)
- Testing
- Amulet Left Atrial Appendage Occluder, WATCHMAN Left Atrial Appendage Closure
- Where
- 115 sites in United States, Australia and 9 more
- Volunteers
- 1,878 people
- Sponsor
- Abbott Medical Devices
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
Aortic Valve Stenosis
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery…
- Trial name
- NCT01238835
- Testing
- SAPIEN XT™ Transapical aortic valve replacement
- Where
- 20 sites in Austria, France and 2 more
- Volunteers
- 220 people
- Sponsor
- Edwards Lifesciences
Coronary Artery Disease, Atrial Fibrillation
A Study Based on Japanese Medical Records That Looks at Bleeding Events in People With Atrial Fibrillation and Coronary Artery Disease Who Start Taking Either Dabigatran, Rivaroxaban, or Warfarin
The study aims to evaluate the safety and effectiveness comparisons between warfarin, dabigatran, and rivaroxaban in routine clinical practice among Japanese non-valvular atrial fibrillation (NVAF) patients with concomitant…
- Trial name
- NCT05051904
- Where
- Germany
- Volunteers
- 39,357 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese).
- Trial name
- NCT00494871
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Warfarin
- Where
- 165 sites in Japan
- Volunteers
- 1,280 people
- Sponsor
- Bayer
Atrial Fibrillation
Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin
Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the…
- Trial name
- EXPLORE-Xa (NCT00742859)
- Testing
- betrixaban, Warfarin
- Where
- 21 sites in United States, Canada
- Volunteers
- 508 people
- Sponsor
- Portola Pharmaceuticals