Clinical trials: Coronary Disease
Heart Failure
Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials
Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.
- Trial name
- HW-PAS-03 (NCT01832610)
- Testing
- HeartWare® VAS
- Where
- 25 sites in United States
- Volunteers
- 101 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Recurrent Pericarditis
A Pilot Study of KPL-914 in Recurrent Pericarditis
The purpose of this study is to assess the preliminary efficacy and safety of KPL-914 treatment in participants with recurrent pericarditis.
- Trial name
- NCT03980522
- Testing
- KPL-914
- Where
- 14 sites in United States
- Volunteers
- 26 people
- Sponsor
- Kiniksa Pharmaceuticals (UK), Ltd.
Congestive Heart Failure, Cardiac Resynchronization Therapy
TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D
This feasibility study will investigate the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the follow-up treatment of patients implanted…
- Trial name
- NCT00395642
- Testing
- Kronos LV-T, Lumax HF-T
- Where
- 12 sites in United States
- Volunteers
- 66 people
- Sponsor
- Biotronik, Inc.
Advanced Refractory Left Ventricular Heart Failure
HeartMate 3 CE Mark Study Long Term Follow-up
The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS…
- Trial name
- HM3 CE LTFU (NCT03022461)
- Testing
- Long term follow-up
- Where
- 8 sites in Australia, Austria and 4 more
- Volunteers
- 25 people
- Sponsor
- Abbott Medical Devices
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
Atrial Fibrillation, Arrhythmias, Cardiac
Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias
This post-marketing study is conducted to characterize the ability of Apple Watch rhythm analysis software to identify Atrial Fibrillation (AF) and facilitate subsequent clinical evaluation among users who contact AppleCare.
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter
- Trial name
- NCT03769207
- Testing
- Ambulatory ECG
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
Pulmonary Valve Insufficiency, Pulmonary Regurgitation
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction
- Trial name
- NCT00676689
- Testing
- SAPIEN Transcatheter Valve Implantation
- Where
- 7 sites in United States
- Volunteers
- 81 people
- Sponsor
- Edwards Lifesciences
Pulmonary Arterial Hypertension
A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging
The purpose of the study is to assess the effects of selexipag on right ventricular (RV) function in participants with Pulmonary arterial hypertension (PAH).
- Trial name
- RESTORE (NCT04435782)
- Testing
- JNJ-67896049
- Where
- 35 sites in United States, Argentina and 13 more
- Volunteers
- 9 people
- Sponsor
- Actelion
Bradycardia, Sinus Node Dysfunction
Safety and Performance Study of the INGEVITY Lead
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.
- Trial name
- NCT01688843
- Testing
- INGEVITY lead
- Where
- 78 sites in United States, Australia and 14 more
- Volunteers
- 1,060 people
- Sponsor
- Boston Scientific Corporation
Acute Kidney Injury
A Study of THR-184 in Patients at Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI)
The purpose of this study is to determine whether THR-184 when administered around the time of cardiac surgery that requires cardiopulmonary bypass can prevent or ameliorate the development of acute kidney injury.
- Trial name
- NCT01830920
- Testing
- THR-184
- Where
- 41 sites in United States, Canada
- Volunteers
- 452 people
- Sponsor
- Thrasos Innovation, Inc.
Mitral Regurgitation
Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.
To evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.
- Trial name
- ASCEND (NCT04382612)
- Testing
- HARPOON Beating Heart Mitral Valve Repair System (MVRS)
- Where
- 10 sites in Austria, Germany and 2 more
- Volunteers
- 42 people
- Sponsor
- Edwards Lifesciences
Heart Failure
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction
The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY1067197) when given in addition to appropriate therapy for specific comorbidities.
- Trial name
- PANACHE (NCT03098979)
- Testing
- Neladenoson bialanate (BAY1067197)
- Where
- 76 sites in United States, Austria and 10 more
- Volunteers
- 305 people
- Sponsor
- Bayer
Velo-cardio-facial Syndrome, Psychosis
Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velocardiofacial Syndrome
This is an exploratory clinical investigation. The objectives of this study are to evaluate the safety, steady-state pharmacokinetics, and efficacy of metyrosine (Demser®) for the treatment of psychosis in patients with…
- Trial name
- NCT01127503
- Testing
- Metyrosine
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Bausch Health Americas, Inc.
Aortic Valve Disease
Trifecta™ Durability Study
The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve.
- Trial name
- NCT01256710
- Testing
- Trifecta™ aortic bioprosthesis
- Where
- Germany
- Volunteers
- 1,151 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)
This is a post-market study collecting real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System)
- Trial name
- POLAR SMART (NCT05282823)
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 19 sites in Japan, South Korea
- Volunteers
- 295 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation
The purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of atrial fibrillation (AF) based on information from a pacemaker or implantable cardioverter…
- Trial name
- TACTIC AF (NCT01650298)
- Testing
- Drug (Direct thrombin or Factor Xa inhibitor)
- Where
- 10 sites in United States
- Volunteers
- 64 people
- Sponsor
- Abbott Medical Devices
Congestive Heart Failure
Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
To confirm the tolerability of intravenous administration of OPC-61815 at 8 or 16 mg once daily for a maximum of 5 days to CHF patients with volume overload despite having received diuretics (injection) other than vasopressin…
- Trial name
- NCT03962101
- Testing
- OPC-61815 injection
- Where
- Japan
- Volunteers
- 45 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Heart Failure, Chronic Heart Failure With Reduced Ejection Fraction
A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001)
This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of vericiguat (MK-1242) in participants with heart failure with reduced ejection fraction (HFrEF).
- Trial name
- VICTORIA (NCT02861534)
- Testing
- Vericiguat
- Volunteers
- 5,050 people
- Sponsor
- Merck Sharp & Dohme LLC
Coronary Artery Disease
AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD).
This is a randomized, single-blind, placebo-controlled, parallel-group, multicentre study in patients with CAD. The study will be conducted at approximately 10 centres in 3 countries.
- Trial name
- FLAVOUR (NCT03317002)
- Testing
- AZD5718
- Where
- 9 sites in Denmark, Finland and 1 more
- Volunteers
- 129 people
- Sponsor
- AstraZeneca
Coronary Artery Disease, Coronary Stenosis
FUnctional diagnoSIs of corONary Stenosis (FUSION)
The purpose of the FUSION study is to validate the diagnostic performance of Virtual Flow Reserve (VFR) by comparing it against a reference standard, fractional flow reserve (FFR).
- Trial name
- FUSION (NCT04356027)
- Testing
- ICA (Invasive Coronary Angiography), OCT, FFR
- Where
- 28 sites in United States
- Volunteers
- 312 people
- Sponsor
- Abbott Medical Devices
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