Clinical trials: High-risk Cardiac Patients
Atrial Fibrillation
REVEAL AF: Incidence of AF in High Risk Patients
This study is to determine, through continuous monitoring with the Reveal implantable cardiac monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be at high risk for having AF and to understand how…
- Trial name
- NCT01727297
- Testing
- REVEAL Implantable Cardiac Monitor
- Where
- 58 sites in United States, Austria and 5 more
- Volunteers
- 446 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation (AF)
Study to Evaluate the effIcacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral Anticoagulation
This OLE part is an optional, single arm, multicenter, open-label extension (OLE) added to the core part to assess the long-term safety, tolerability, the incidence of ischemic stroke or SE and bleeding events of abelacimab in…
- Trial name
- LILAC-TIMI 76 (NCT07739888)
- Testing
- Abelacimab
- Volunteers
- 2,500 people
- Sponsor
- Novartis Pharmaceuticals
Paroxysmal Atrial Fibrillation
Oral Anticoagulation Therapy Pilot Study
The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.
- Trial name
- OAT (NCT01959425)
- Testing
- Off OAT Group (Test), On OAT Group (Control)
- Volunteers
- 80 people
- Sponsor
- Biosense Webster, Inc.
Mitral Regurgitation, Mitral Valve Disease
AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation.
- Trial name
- AHEAD (NCT03339115)
- Testing
- Cardiovalve Transfemoral Mitral Valve
- Where
- 11 sites in Germany, Greece and 1 more
- Volunteers
- 30 people
- Sponsor
- Cardiovalve Ltd.
Coronary Artery Bypass Graft Surgery, Myocardial Ischemia
A Safety and Efficacy Study to Confirm the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG
The purpose of this study is to determine the effect of MC-1 on the combined incidence of cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days following coronary artery bypass graft (CABG)…
- Conditions
- Coronary Artery Bypass Graft Surgery, Myocardial Ischemia, Reperfusion Injury
- Trial name
- NCT00402506
- Testing
- (MC-1) Pyridoxal 5'-phosphate
- Where
- 2 sites in United States, Canada
- Volunteers
- 3,000 people
- Sponsor
- Medicure
Hypercholesterolemia, Coronary Heart Disease
Effectiveness and Safety of Ezetimibe Added to Atorvastatin in Patients With High Cholesterol and Coronary Heart Disease (Study P03740)
This is a multicenter, randomized, parallel group, placebo controlled study designed to evaluate the efficacy, safety, and tolerability of ezetimibe added to ongoing atorvastatin therapy compared with ongoing atorvastatin…
- Trial name
- NCT00202904
- Testing
- ezetimibe
- Volunteers
- 81 people
- Sponsor
- Organon and Co
Atrial Fibrillation
Omega™ Left Atrial Appendage (LAA) Occluder in Patients With Non-Valvular Atrial Fibrillation
Atrial fibrillation is associated with increased risk of stroke mostly because of clot formation in the left atrial appendage, a small alcove in the left atrium heart chamber.
- Trial name
- NCT03526471
- Testing
- Omega™ Left Atrial Appendage (LAA) Occluder
- Where
- 2 sites in Denmark, Thailand
- Volunteers
- 20 people
- Sponsor
- Vascular Innovations Co. Ltd.
Acute Myocardial Infarction
SpinChip Hs-cTnI Clinical Diagnostic Performance
During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack.
- Trial name
- HEAT-4 (NCT06499519)
- Testing
- SpinChip hs-cTnI
- Where
- 9 sites in Denmark, Germany and 4 more
- Volunteers
- 1,551 people
- Sponsor
- SpinChip Diagnostics ASA
Heart Failure, Congestive
FUSION I Assesses Safety and Tolerability of Two Doses of NATRECOR (Nesiritide) Administered to Patients With Worsening Congestive (Decompensated) Heart Failure Who Are Concurrently Receiving Their Usual Cardiac Medications and Are at High Risk for Hospitalization.
The purpose of this study is to assess the safety and tolerability of two doses of nesiritide (a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) when administered…
- Trial name
- NCT00270361
- Testing
- nesiritide, usual long term cardiac medications
- Volunteers
- 214 people
- Sponsor
- Scios, Inc.
High-Risk Percutaneous Coronary Intervention
Magenta Elevate™ First-in-Human Clinical Study in High-Risk PCI Patients
The Elevate™ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk…
- Trial name
- ELEVATE I (NCT06099548)
- Testing
- The Elevate™ System
- Where
- 2 sites in Georgia
- Volunteers
- 20 people
- Sponsor
- Magenta Medical Ltd.
Acute Coronary Disease, Angina Unstable
Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS
The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a…
- Trial name
- CURRENT/OASIS7 (NCT00335452)
- Testing
- Clopidogrel, acetylsalicyclic acid (ASA)
- Where
- 38 sites in United States, Argentina and 36 more
- Volunteers
- 25,086 people
- Sponsor
- Sanofi
Myocardial Infarction, Acute Coronary Syndromes
Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention
The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a shortened infusion duration compared to label-dosing eptifibatide in patients undergoing percutaneous coronary intervention (PCI) is…
- Conditions
- Myocardial Infarction, Acute Coronary Syndromes, Unstable Angina
- Trial name
- SAVI-PCI (NCT01522417)
- Testing
- Short Tirofiban, Eptifibatide, Long Tirofiban
- Where
- 13 sites in United States
- Volunteers
- 535 people
- Sponsor
- Medicure
Hypercholesterolemia, Coronary Heart Disease
Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)
In an observational multi-centre study (CHALLENGE), the effects were assessed of starting treatment with low doses of rosuvastatin in statin naive patients with a history of coronary heart disease (CHD), peripheral vascular…
- Conditions
- Hypercholesterolemia, Coronary Heart Disease, Peripheral Vascular Disease, CVA
- Trial name
- CHALLENGE (NCT00574782)
- Volunteers
- 2,660 people
- Sponsor
- AstraZeneca
Cardiac Surgery, Cardiopulmonary Bypass
Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass
This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to determine the safety and effectiveness of human-derived antithrombin III (AT-III [Human]) supplementation…
- Trial name
- NCT02037555
- Testing
- AT-III (Human)
- Where
- 41 sites in United States
- Volunteers
- 425 people
- Sponsor
- Grifols Therapeutics LLC
Aortic Valve Stenosis
PrizValve® Transcatheter Aortic Valve Replacement Study
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not…
- Trial name
- NCT04836897
- Testing
- PrizValve® valve and transapical delivery system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
High-risk PCI
Evaluate the Effectiveness and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device in Providing Hemodynamic Support for Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).
The objective of this clinical trial is to understand the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device produced by ShanghaiDynaheart Medical Technology Co., Ltd.
- Trial name
- NCT07622446
- Testing
- OmniHeart 4.0 Percutaneous Ventricular Assist Device, ECMO
- Where
- 2 sites in China
- Volunteers
- 254 people
- Sponsor
- Shanghai Dynaheart Medtech Co., Ltd.
Coronary Arteriosclerosis, Diabetes Mellitus, Type 2
Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets
European physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol.
- Conditions
- Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident, Dyslipidemia
- Trial name
- ACTFAST 2 (NCT00442325)
- Testing
- Atorvastatin (Lipitor)
- Where
- 32 sites in Greece, Hungary and 6 more
- Volunteers
- 595 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Stable Angina, Ischemic Heart Disease Silent
A Randomized Clinical Evaluation of the BioFreedom™ Stent
The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and…
- Conditions
- Stable Angina, Ischemic Heart Disease Silent, ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction, In-stent Coronary Artery Restenosis
- Trial name
- Leaders Free (NCT01623180)
- Testing
- Biofreedom™ Drug Coated Stent (DCS), Gazelle™ Bare Metal Coronary Stent (BMS)
- Where
- Switzerland
- Volunteers
- 2,456 people
- Sponsor
- Biosensors Europe SA
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
- Conditions
- Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology, Mechanical Circulatory Support
- Trial name
- SUPPORT II (NCT07296744)
- Testing
- The Supira System, Impella
- Where
- 25 sites in United States
- Volunteers
- 358 people
- Sponsor
- Supira Medical
Hyperkalemia
Tracking Treatment Pathways in Adult Patients With Hyperkalemia.
This study aims to increase the understanding of Hyperkalemia (HK) management, treatment patterns, and the treatment decision-making process for the management of patients with HK over a period of up to 12 months.
- Trial name
- TRACK (NCT05408039)
- Where
- 74 sites in United States, Germany and 3 more
- Volunteers
- 1,331 people
- Sponsor
- AstraZeneca