Clinical trials: Valvular Diseases
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
Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan
The primary objective of this study is to compare the Length of Stay from treatment of oral anticoagulant initiation to hospital discharge of patients hospitalized and subsequently treated with dabigatran or warfarin for…
- Trial name
- NCT02631057
- Testing
- Dabigatran, Warfarin
- Where
- 2 sites in Japan
- Volunteers
- 4,313 people
- Sponsor
- Boehringer Ingelheim
Non-valvular Atrial Fibrillation
Safety and Effectiveness of Apixaban Compared to Warfarin in Secondary Prevention in Patients With Atrial Fibrillation
The purpose of this study are 1) to characterize the primary and secondary prevention patients, 2) to calculate incidence rates of stroke/SE or major bleeding in each cohort and 3) to investigate for Japanese secondary prevention…
- Trial name
- NCT05321810
- Testing
- Apixaban, Warfarin
- Where
- Japan
- Volunteers
- 193,565 people
- Sponsor
- Pfizer
Stroke
Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation
The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial…
- Trial name
- ASAP-TOO (NCT02928497)
- Testing
- WATCHMAN LAAC Device Implant, Single Antiplatelet Therapy or No Therapy (Control)
- Where
- 92 sites in United States, Belgium and 7 more
- Volunteers
- 481 people
- Sponsor
- Boston Scientific Corporation
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
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, 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
Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation
There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based…
- Trial name
- ELIMINATE-AF (NCT02942576)
- Testing
- Edoxaban, VKA-Based Regimen
- Where
- 75 sites in Belgium, Canada and 9 more
- Volunteers
- 632 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Atrial Fibrillation
The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage
This study is an opportunity for Boehringer Ingelheim to collaborate with Humana to conduct comparative safety and effectiveness studies of dabigatran and warfarin using real world data from Humana's health plan operations.
- Trial name
- NCT02061748
- Testing
- Observational
- Where
- United States
- Volunteers
- 38,499 people
- Sponsor
- Boehringer Ingelheim
Non-valvular Atrial Fibrillation
Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) Compared to Warfarin Using Administrative Claims Data
The objective of this study is to investigate safety and effectiveness of apixaban compared to warfarin in very elderly patients with Non-valvular atrial fibrillation (NVAF).
- Trial name
- NCT05438888
- Testing
- Warfarin, Apixaban
- Where
- Japan
- Volunteers
- 77,814 people
- Sponsor
- Pfizer
Acute Coronary Syndrome
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death…
- Trial name
- AEGIS-II (NCT03473223)
- Testing
- Apolipoprotein A-I [human] (apoA-I)
- Where
- 903 sites in United States, Argentina and 47 more
- Volunteers
- 18,226 people
- Sponsor
- CSL Behring
Atrial Fibrillation, AFib
Stroke Feasibility Study
This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage.
- Trial name
- NCT01997905
- Testing
- AtriClip LAA Exclusion Device
- Where
- 7 sites in United States
- Volunteers
- 13 people
- Sponsor
- AtriCure, Inc.
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 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
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