Clinical trials: Cardiac Flow
Coronary Artery Disease
PMCF Study for Cardiology Access Procedures
This Post-market clinical follow-up (PMCF) study is designed as retrospective, multi-center study to collect real-life data. A multi-center design is used to ensure a representative sample of the physicians who have performed the…
- Trial name
- NCT05543096
- Testing
- Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Catheters, Cordis Guidewires
- Where
- 8 sites in Austria, Belgium
- Volunteers
- 200 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease, Coronary Disease
Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for Physiological Measurements
TruePhysio pressure microcatheter is a novel device for evaluating the functional significance of coronary stenosis, and its safety and efficacy on the measurement of hyperemic index have been validated in the previous SUPREME…
- Conditions
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
- Trial name
- SUPREME II (NCT05417763)
- Testing
- Randomized physiological measurements by the two systems
- Where
- 11 sites in China
- Volunteers
- 487 people
- Sponsor
- Insight Lifetech Co., Ltd.
Heart Failure
Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.
- Trial name
- ALT-FLOW US (NCT03523416)
- Testing
- Edwards APTURE transcatheter shunt system
- Where
- 19 sites in United States
- Volunteers
- 90 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
The primary objective of this study is to collect data to confirm the performance and safety of the True™ Flow Valvuloplasty Perfusion Catheter during dilatation of the aortic valve in the preparation for Transcatheter Aortic…
- Trial name
- True™Flow (NCT02847546)
- Testing
- True™ Flow Valvuloplasty Perfusion Catheter
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- C. R. Bard
Cardiac Bypass Surgery (CABG)
Collect Flow and Ultrasound Images of Coronary Bypass Grafts
This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG).
- Trial name
- CASES (NCT06360224)
- Testing
- MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probes
- Volunteers
- 100 people
- Sponsor
- Medistim ASA
Aortic Valve Stenosis
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial…
- Trial name
- DISCOVER (NCT01845285)
- Testing
- Aortic Valve Replacement
- Where
- 2 sites in Germany, Italy
- Volunteers
- 1,000 people
- Sponsor
- Direct Flow Medical, Inc.
Coronary Artery Disease
Post-Market Registry of the ACIST CPM System and Navvus Catheter in Clinical Practice
This registry will collect real-world clinical evidence on the performance, safety, and usability of the ACIST CPM System and NAVVUS Catheter when used in accordance with approved labeling in a European commercial setting.
- Trial name
- ADVANCE-EU (NCT02060682)
- Testing
- Navvus Catheter FFR
- Where
- 7 sites in France, Germany and 2 more
- Volunteers
- 60 people
- Sponsor
- Acist Medical Systems
Atherosclerosis, Inflammatory Activity in Coronary Arteries
Exploratory Study of Coronary Flow Reserve Measurements, a Non-Invasive Method for Coronary Function Measurements
The aim of this study is to investigate whether the non-invasive ultrasound method for assessment of coronary blood flow, transthoracic Doppler echocardiography-coronary flow reserve (TTDE-CFR), can be used to measure drug…
- Trial name
- NCT00783042
- Testing
- Rosuvastatin
- Where
- Sweden
- Volunteers
- 80 people
- Sponsor
- AstraZeneca
Coronary Artery Disease
User Evaluation Study of SyncVision System With Software v4.X
This is a prospective, single-arm, unblinded, case observation study evaluating a commercially released 'Conformité Européenne' (CE)-mark co-registration software system along-side of a commercially- released CE-mark coronary…
- Trial name
- Prepare II (NCT02915991)
- Where
- 2 sites in Israel
- Volunteers
- 35 people
- Sponsor
- Volcano Corporation
Coronary Disease
The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses
The purpose of this registry is to collect real life information and to document the performance and user friendliness of iFR in daily diagnostic practice and treatment strategies for MVD patients undergoing cardiac…
- Trial name
- DEFINE REAL (NCT02281110)
- Testing
- iFR/FFR
- Where
- Belgium
- Volunteers
- 500 people
- Sponsor
- Volcano Corporation
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation
FLOW EVAL-AF is a prospective, observational, single center pilot trial. The FLOW EVAL-AF trial is designed to identify driver sources in patients with persistent or longstanding persistent AF using EGF mapping and describe the…
- Conditions
- Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent, Arrhythmias, Cardiac
- Trial name
- FLOW EVAL-AF (NCT06260670)
- Testing
- Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Ablacon, Inc.
Heart Diseases, Cardiovascular Diseases
Trial Evaluating New Strategy in the Functional Assessment of 3-vessel Disease Using SYNTAXII Score in Patients With PCI
Clinical study that aims to evaluate a new strategy using the SYNTAX II Score calculator in the functional assessment of patients with new coronary 3-vessel-disease who undergo percutaneous coronary intervention (PCI)
- Conditions
- Heart Diseases, Cardiovascular Diseases, 3 Vessel Coronary Artery Disease
- Trial name
- NCT02015832
- Testing
- Coronary stent, Multi Slice Computed Tomography, instantaneous wave-free ratio
- Where
- 22 sites in Netherlands, Poland and 2 more
- Volunteers
- 454 people
- Sponsor
- ECRI bv
Refractory Angina Pectoris, Ischemic Heart Disease
Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve
The purpose of the study is to assess the feasibility of Cardiac Shock Wave Treatment in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the…
- Conditions
- Refractory Angina Pectoris, Ischemic Heart Disease, Coronary Artery Disease
- Trial name
- NCT03438500
- Testing
- Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)
- Where
- Germany
- Sponsor
- Storz Medical AG
Heart Failure
Study to Evaluate the Effects of AZD3427 in Patients With Heart Failure
The primary purpose of this mechanistic study is to evaluate the vasodilatory effects of AZD3427 in adult patients with heart failure and will be performed at approximately 2 study sites in the United Kingdom.
- Trial name
- NCT04890548
- Testing
- AZD3427
- Sponsor
- AstraZeneca
Congestive Heart Failure (CHF)
Evaluation of Blood Flow Patterns in Lung Blood Vessels Using Ultrasound Technique in Patients With Congestive Heart Failure
Historically, transthoracic Doppler echocardiography has been unable to provide interpretable data of blood flow within the lung parenchyma because of air attenuation of Doppler signals.
- Trial name
- NCT01744210
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Echosense Ltd.
Aortic Valve Stenosis
TranScatheter Aortic Valve RepLacement System US Feasibility Trial
A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve system. This is for people with severe aortic stenosis who are not well enough to undergo a surgical repair.
- Trial name
- SALUS (NCT01932099)
- Testing
- Transcatheter aortic valve replacement
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Direct Flow Medical, Inc.
Atrial Fibrillation (AF), Persistant Atrial Fibrillation
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources)…
- Trial name
- OPTIMIZE (NCT07187115)
- Testing
- FARAPOINT Pulsed Field Ablation System, OptiMap System (non-ablative), FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System
- Where
- 15 sites in United States, Belgium and 2 more
- Volunteers
- 699 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease, Cardiovascular Diseases
Functional Diagnostic Accuracy of Quantitative Flow Ratio in Tandem Lesions and Virtual Stenting
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Virtual stent implantation technique combined with QFR was recently developed to predict the functional significance…
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia, Arterial Occlusive Diseases
- Trial name
- FORTRESS (NCT03405506)
- Testing
- Quantitative Flow Ratio (QFR)
- Where
- China
- Volunteers
- 308 people
- Sponsor
- Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Aortic Stenosis
OpSens PRIME CLASS
In this study it is aimed to determine the diagnostic value of physiological measurements in the presence of aortic stenosis, and whether these are more accurate than angiographic assessment.
- Trial name
- NCT05070130
- Testing
- dPR and FFR
- Where
- 5 sites in Spain
- Volunteers
- 32 people
- Sponsor
- Opsens, Inc.
Multi Vessel Coronary Artery Disease
Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease
This is a prospective, observational, single-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diagnosing hemodynamically…
- Trial name
- NCT03455244
- Testing
- FFRangio
- Where
- Japan
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- CathWorks Ltd.