Clinical trials: Cardiac Flow
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
Coronary Artery Disease
Coronary Flow Reserve Following Orbital Atherectomy
The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting.
- Trial name
- NCT02339545
- Testing
- Coronary Orbital Atherectomy plus Stenting
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
HeartFlowNXT - HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography
To determine the diagnostic performance of FFRCT by coronary computed tomographic angiography (cCTA), as compared to cCTA alone, for non-invasive determination of the presence of a hemodynamically significant coronary lesion…
- Trial name
- HFNXT (NCT01757678)
- Testing
- ICA (Invasive Coronary Angiography), FFR (Fractional Flow Reserve), cCTA (coronary computed tomography angiography)
- Where
- Denmark
- Volunteers
- 276 people
- Sponsor
- HeartFlow, Inc.
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
Coronary Artery Disease, Acute Coronary Syndrome
PRESSUREwire Study
The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice.
- Trial name
- NCT02935088
- Testing
- Fractional Flow Reserve
- Where
- 71 sites in United States, Austria and 13 more
- Volunteers
- 2,217 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.
- Trial name
- NCT01132495
- Testing
- Stenting plus OMT, OMT, Standard of care
- Where
- 29 sites in United States, Belgium and 11 more
- Volunteers
- 1,170 people
- Sponsor
- Abbott Medical Devices
Sleep Disordered Breathing, Congestive Heart Failure
Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep
Respiratory insufficiencies during sleep can lead to reductions in the level of oxygen in the blood during the night, which has been shown to contribute to a range of morbidities.
- Trial name
- NCT02152566
- Testing
- Nasal High flow therapy device
- Where
- 2 sites in New Zealand
- Volunteers
- 6 people
- Sponsor
- Fisher and Paykel Healthcare
Atrial Fibrillation, Persistent, Atrial Fibrillation
AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation
This post-market global registry will evaluate the ability of Electrographic Flow (EGF™) mapping to identify atrial fibrillation (AF) sources and guide ablation therapy in patients with atrial fibrillation in real-world setting.
- Conditions
- Atrial Fibrillation, Persistent, Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases
- Trial name
- NCT05481359
- Testing
- Electrographic Flow™ (EGF) mapping and ablation
- Where
- 5 sites in United States, Netherlands and 1 more
- Volunteers
- 25 people
- Sponsor
- Ablacon, Inc.
Coronary Artery Disease
Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed…
- Trial name
- DeFACTO (NCT01233518)
- Testing
- FFR
- Where
- United States
- Volunteers
- 285 people
- Sponsor
- HeartFlow, Inc.
Coronary Heart Disease
A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients
This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents.
- Trial name
- NCT00655538
- Testing
- dalcetrapib
- Where
- 23 sites in Austria, France and 5 more
- Volunteers
- 476 people
- Sponsor
- Hoffmann-La Roche
Coronary Artery Disease
Observational Study of OCT in a Patients Undergoing FFR
The purpose of this study is to define and evaluate optical coherence tomography (OCT) stent guidance parameters through prospective data collection in percutaneous coronary intervention (PCI) procedures of de novo lesions.
- Trial name
- ILUMIEN I (NCT01663896)
- Testing
- OCT stent guidance
- Where
- 36 sites in United States, Australia and 12 more
- Volunteers
- 418 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Diseases, Multivessel Coronary Artery Disease
SYNTAX III REVOLUTION Trial: A Randomized Study Investigating the Use of CT Scan and Angiography of the Heart to Help the Doctors Decide Which Method is the Best to Improve Blood Supply to the Heart in Patients With Complex Coronary Artery Disease
The SYNTAX III Revolution trial is a randomized diagnostic research study that investigates the use of CT scan and angiogram of the heart to help doctors decide which method is the best to improve blood supply to the heart in…
- Conditions
- Coronary Artery Diseases, Multivessel Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases
- Trial name
- SYNTAX III (NCT02813473)
- Testing
- Coronary Angiography, Computed Tomography (CT) scan
- Where
- 6 sites in Belgium, France and 3 more
- Volunteers
- 223 people
- Sponsor
- ECRI bv
Coronary Artery Disease
SHIELD II Clinical Investigation
The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with…
- Trial name
- SHIELD II (NCT02468778)
- Testing
- HeartMate PHP, Any Abiomed Impella® device approved for use in high-risk PCI
- Where
- 58 sites in United States
- Volunteers
- 54 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Persistent
FLOW-AF: A Study to Evaluate Electrographic Flow™ (EGF) Mapping Technology
This study is to evaluate Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software).
- Trial name
- FLOW-AF (NCT04473963)
- Testing
- Electrographic Flow™ guided ablation
- Where
- 4 sites in Czechia, Germany and 1 more
- Volunteers
- 85 people
- Sponsor
- Cortex