Clinical trials: High-risk Cardiac Patients, open to volunteers
- Condition High-risk Cardiac Patients
- Status Open to volunteers
- Funder type Industry (pharma, biotech, devices)
High-Risk Percutaneous Coronary Intervention
Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol
The Impella ECP Study is a prospective, multi-center, single-arm study evaluating the rate of major adverse cardiovascular and cerebrovascular events (MACCE) with the Impella ECP device in adult patients undergoing elective or…
- Trial name
- NCT05334784
- Testing
- Impella ECP
- Where
- 32 sites in United States
- Volunteers
- 856 people
- Sponsor
- Abiomed Inc.
Tricuspid Regurgitation
Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation
Participants with severe tricuspid regurgitation may require heart surgery to repair or replace the tricuspid valve. However, there is a high risk associated with these surgeries and it is often not feasible for elderly patients…
- Trial name
- SPACER (NCT07172477)
- Testing
- Pivot Extend
- Where
- Australia
- Volunteers
- 10 people
- Sponsor
- Tau Medical Australia Pty Ltd
Severe Aortic Stenosis
Colibri Transcatheter Aortic Heart Valve System Study
The Colibri Heart Valve clinical investigation ("COL-01") is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results.
- Trial name
- NCT04029844
- Testing
- Colibri TAVI System
- Where
- 5 sites in France, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Colibri Heart Valve LLC
Coronary Artery Disease, Chronic Stable Angina
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™…
- Conditions
- Coronary Artery Disease, Chronic Stable Angina, Unstable Angina, Silent Ischemia
- Trial name
- NCT06657326
- Testing
- BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent, BioFreedom™ stainless steel Biolimus A9™-coated stent
- Where
- 6 sites in Malaysia
- Volunteers
- 444 people
- Sponsor
- Biosensors Europe SA
Intensive Care Unit, Coronary Artery Bypass Grafting (CABG)
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy. A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight…
- Conditions
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass
- Trial name
- MODIFY CSX (NCT06279793)
- Testing
- Fish Oil, Intravenous 0.9% Sodium Chloride
- Where
- 10 sites in Germany
- Volunteers
- 550 people
- Sponsor
- GCP-Service International West GmbH
Tachycardia, Ventricular
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
RADIATE-VT is a pivotal, multicenter, randomized trial comparing safety and efficacy between cardiac radioablation (CRA) using the Varian CRA System and repeat catheter ablation (CA), for patients with high-risk refractory…
- Trial name
- RADIATE-VT (NCT05765175)
- Testing
- Varian Cardiac Radioablation (CRA), Catheter Ablation (CA)
- Where
- 11 sites in United States
- Volunteers
- 380 people
- Sponsor
- Varian, a Siemens Healthineers Company
Aortic Valve Stenosis
Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are…
- Trial name
- NCT05864456
- Testing
- Prizvalve Pro™ transcatheter aortic valve system
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Heart Failure
Study to Collect High-Resolution ECG Data and Patient Insights on Heart Failure Care
The purpose of this study is to establish an electrocardiogram (ECG) data library to facilitate future studies on heart disease.
- Trial name
- NCT06809686
- Where
- 2 sites in United Kingdom
- Volunteers
- 1,000 people
- Sponsor
- Richmond Research Institute
Mitral Valve Regurgitation
Mi-thos® Transcatheter Mitral Valve Replacement Study
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
- Trial name
- NCT04195984
- Testing
- Mi-thos® valve and transapical delivery system
- Where
- 3 sites in China
- Volunteers
- 122 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Hidradenitis Suppurativa
A Real-world Study of Patients With Hidradenitis Suppurativa and High Cardiovascular Risk or Established Coronary Plaque Treated With Secukinumab
The aim of this study is to assess the real-world effects of secukinumab in adult participants with moderate-to-severe Hidradenitis Suppurativa (HS), particularly focusing on its potential impact on coronary atherosclerotic…
- Trial name
- HOPE (NCT07454889)
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Cardiac Surgery Associated - Acute Kidney Injury
Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery
The is a two-stage study. Stage 1 is to evaluate the safety, tolerability, PK and PD of ENN0403 in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass.
- Trial name
- NCT06632613
- Testing
- ENN0403 capsules, low dose, ENN0403 capsules, high dose
- Where
- China
- Volunteers
- 200 people
- Sponsor
- EnnovaBio
High-risk Cardiac Patients
Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform
The WILLEM Registry is a large-scale, single-group, observational, registry study to collect continuous clinical evidence of Willem in real-world settings.
- Trial name
- WILLEMRegistry (NCT07333547)
- Testing
- Willem AI ECG assessment
- Where
- 5 sites in United States, Ecuador and 1 more
- Volunteers
- 200,000 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Mitral Regurgitation
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
- Trial name
- NCT04029363
- Testing
- HighLife Transcatheter Mitral Valve Replacement
- Where
- 50 sites in Australia, Belgium and 5 more
- Volunteers
- 120 people
- Sponsor
- HighLife SAS
Mitral Regurgitation
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
- Trial name
- HighFLO (NCT04888247)
- Testing
- CLARITY
- Where
- 14 sites in Australia, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- HighLife SAS
Coronary Artery Disease (CAD)
BASel Kosten-Effektivitäts-Trial: Drug-coated BALLoon (DCB) vs. Drug-eluting Stent (DES) Strategy in High-risk Patients With Coronary Artery Disease (CAD)
The main objective of this randomized, multicenter, international, open-label clinical trial is to demonstrate that, in the context of percutaneous coronary intervention for complex coronary artery disease, a SeQuent® SCB…
- Trial name
- BASKET BALL (NCT07363161)
- Testing
- PCI
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 2,184 people
- Sponsor
- B. Braun Melsungen AG
Aortic Regurgitation, Aortic Disease
Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR
Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.
- Conditions
- Aortic Regurgitation, Aortic Disease, Calcified Aortic Valve
- Trial name
- MARVELTAVI (NCT07751965)
- Testing
- Myval THV series
- Volunteers
- 164 people
- Sponsor
- Ceric Sàrl
Acute Kidney Injury
Study of the Relaxin Agonist R2R01 in Patients at High Risk for Cardiac Surgery Associated- Acute Kidney Injury
This is a Phase 2, dose-ranging, double-blind, double-dummy, placebo-controlled, randomized study preceded by an open label safety run-in, in patients at high risk for Cardiac Surgery Associated - Acute Kidney Injury (CSA-AKI)…
- Trial name
- CSA-AKI (NCT07625553)
- Testing
- R2R01
- Where
- Italy
- Volunteers
- 430 people
- Sponsor
- River 2 Renal Corp.
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
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
Cardiomyopathies, Cardiac Arrest
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
WILLEM is a multi-center, prospective and retrospective cohort study. The study will assess the performance of a cloud-based and AI-powered ECG analysis platform, named Willem™, developed to detect arrhythmias and other abnormal…
- Conditions
- Cardiomyopathies, Cardiac Arrest, Cardiac Arrhythmias, Sudden Cardiac Death
- Trial name
- WILLEM (NCT05890716)
- Testing
- AI-powered ECG analysis to detect cardiac arrhythmic episodes
- Where
- 13 sites in Netherlands, Spain
- Volunteers
- 5,342 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.