Clinical trials: Heart Disease, Valvular
Atrial Fibrillation
Burden of Illness in Atrial Fibrillation
The overall goal of this retrospective registry study is to investigate the burden-of.illness in atrial fibrillation (AF) in Denmark.
- Trial name
- NCT02615587
- Testing
- Standard of care in AF in Denmark
- Where
- Denmark
- Volunteers
- 107,532 people
- Sponsor
- Bayer
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
AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency
Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with TAVR without embolic protection (unprotected TAVR).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency, Aortic Valve Regurgitation, Aortic Valve Replacement
- Trial name
- EMBLOK II (NCT07129421)
- Testing
- EMBLOK™ Embolic Protection System ("EMBLOK EPS")
- Volunteers
- 560 people
- Sponsor
- Emblok, Inc.
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
Aortic Stenosis
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the…
- Trial name
- NCT06991517
- Testing
- The ABC Bicuspid Sizing Algorithm
- Where
- 20 sites in Australia, Canada and 6 more
- Volunteers
- 290 people
- Sponsor
- World Health Research Inc.
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
Aortic Valve Stenosis, Heart Valve Diseases
First in Man Study of the JenaValve TAVI Plus System Transfemoral
The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- CP-0001 (NCT02818959)
- Testing
- JenaValve Pericardial TAVR System
- Where
- 2 sites in Germany
- Volunteers
- 7 people
- Sponsor
- JenaValve Technology, Inc.
Severe, Symptomatic Aortic Stenosis
The SOLACE-AU Clinical Trial
The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.
- Trial name
- SOLACE-AU (NCT01675596)
- Testing
- TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
- Where
- 11 sites in Australia
- Volunteers
- 199 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Mitral Insufficiency
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in…
- Trial name
- NCT04161079
- Testing
- Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
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
Aortic Stenosis
PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry
The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.
- Trial name
- PROGRESS (NCT02987894)
- Testing
- ACURATE neo™ Aortic Bioprosthesis
- Where
- 23 sites in Canada, Germany and 2 more
- Volunteers
- 500 people
- Sponsor
- Symetis SA
Aortic Stenosis
transShield Embolic Protection System Feasibility Study
The objective of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT04585308
- Testing
- transShield Embolic Protection System
- Where
- 4 sites in New Zealand, Venezuela
- Volunteers
- 28 people
- Sponsor
- TransAortic Medical, Inc.
Myocardial Ischemia, Coronary Arteriosclerosis
Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo…
- Conditions
- Myocardial Ischemia, Coronary Arteriosclerosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- NCT00082121
- Testing
- TP10
- Where
- 18 sites in United States
- Volunteers
- 300 people
- Sponsor
- Avant Immunotherapeutics
Aortic Stenosis, Aortic Regurgitation
Mitroflow DL Post Approval Study- North America
Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Aortic Valve Insufficiency, Heart Valve Diseases
- Trial name
- NCT02351726
- Testing
- Mitroflow DL
- Where
- 13 sites in United States
- Volunteers
- 186 people
- Sponsor
- LivaNova
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
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.
- Trial name
- NCT01876420
- Testing
- The CoreValve™ Evolut R TAV™ system
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiovascular
Mitral Regurgitation
MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)
This Study is designed to observe the clinical outcomes of patients requiring mitral repair that were treated with the CE certified Cardinal System.
- Trial name
- MITRAFIT (NCT01617720)
- Where
- 2 sites in Germany, Italy
- Volunteers
- 45 people
- Sponsor
- Edwards Lifesciences
Severe Aortic Stenosis, Aortic Regurgitation
Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
The purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality in severe aortic stenosis or…
- Trial name
- TAVI (NCT03788590)
- Testing
- Jenscare TAVI
- Volunteers
- 133 people
- Sponsor
- Ningbo Jenscare Biotechnology Co., Ltd.
Aortic Valve Disease
Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna
The purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.
- Trial name
- NCT00705913
- Testing
- Mitroflow Aortic Pericardial Heart Valve (CarboMedics), Carpentier-Edwards Magna Tissue Valve
- Where
- 12 sites in United States, Canada
- Volunteers
- 368 people
- Sponsor
- Sorin Group USA, Inc.
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