Clinical trials: Valvular Diseases
Aortic Valve Stenosis
Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access
Expand the indication of the Portico TF Delivery System and obtain approval of the Alternative Access Delivery System
- Trial name
- Portico ALT (NCT03056573)
- Testing
- Transaortic TAVR Implant, Subclavian /Axillary TAVR implant
- Where
- 10 sites in Denmark, Germany and 3 more
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
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
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
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, Thromboembolism
A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation
This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF).
- Trial name
- NCT00504556
- Testing
- Edoxaban (DU-176b), warfarin
- Where
- 91 sites in United States, Belarus and 10 more
- Volunteers
- 1,146 people
- Sponsor
- Daiichi Sankyo
Aortic Valve Stenosis
PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan)
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical delivery…
- Trial name
- NCT01113983
- Testing
- Transcatheter aortic valve implantation
- Where
- 3 sites in Japan
- Volunteers
- 64 people
- Sponsor
- Edwards Lifesciences
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
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
EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation
This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or…
- Trial name
- ENTICED-AF (NCT02561897)
- Testing
- Edoxaban, Warfarin
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Electrophysiology Research Foundation
Atrial Fibrillation
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients…
- Trial name
- OPTION (NCT03795298)
- Testing
- WATCHMAN FLX Implant, Market-approved OAC
- Where
- 114 sites in United States, Australia and 8 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
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
Atrial Fibrillation
Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation
The purpose of the prospective, randomized cohort in this study is to assess the safety and efficacy of 2 apixaban treatment strategies (uninterrupted versus interrupted) in subjects planned to undergo catheter ablation for the…
- Trial name
- AEIOU (NCT02608099)
- Testing
- Interrupted apixaban, Uninterrupted apixaban
- Where
- 19 sites in United States
- Volunteers
- 300 people
- Sponsor
- Baim Institute for Clinical Research