Clinical trials: Cardiac Magnetic Resonance
Cardiac Disease
ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads
This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS pacemaker system when used under specific MRI conditions.
- Trial name
- ProMRIAFFIRM (NCT01460992)
- Testing
- Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions
- Where
- 9 sites in Austria, Czechia and 3 more
- Volunteers
- 121 people
- Sponsor
- Biotronik SE & Co. KG
Coronary Artery Disease, Left Ventricular Dysfunction
DEfibrillators To REduce Risk by MagnetIc ResoNance Imaging Evaluation
This trial is a prospective, multi-center, randomized study of patients with coronary artery disease (CAD) and mild to moderate left ventricular (LV) dysfunction.
- Conditions
- Coronary Artery Disease, Left Ventricular Dysfunction, Sudden Cardiac Death
- Trial name
- DETERMINE (NCT00487279)
- Testing
- Defibrillator, Control
- Where
- 56 sites in United States
- Volunteers
- 81 people
- Sponsor
- Abbott Medical Devices
Magnetic Resonance Imaging, Cardiac Pacemaker, Artificial
Advisa MRI Clinical Study
The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR)…
- Trial name
- NCT01110915
- Testing
- Medtronic Advisa MRI Implantable Pulse Generator (IPG), Medtronic CapSureFix MRI™ active fixation MRI lead
- Where
- 37 sites in United States, Australia and 11 more
- Volunteers
- 269 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
Accent Cardiac MRI Study
The aim of this study was to assess safety and efficacy of SJM MRI conditional pacing system. The study hypothesized that cardiac MRI scan would not affect performance of SJM MRI conditional pacing system.
- Trial name
- Accent Cardiac (NCT02041702)
- Testing
- Non-Diagnostic Cardiac MRI scan
- Where
- 13 sites in China, Hong Kong and 3 more
- Volunteers
- 283 people
- Sponsor
- Abbott Medical Devices
Cardiac Disease
DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY
This is a Phase 3, prospective, open-label, multicenter study to evaluate Left Ventricular Ejection Fraction (LVEF) measurement accuracy and reproducibility of DEFINITY® contrast-enhanced and unenhanced echocardiography as…
- Trial name
- BENEFIT1 (NCT03571672)
- Testing
- DEFINITY
- Where
- 9 sites in United States
- Volunteers
- 153 people
- Sponsor
- Lantheus Medical Imaging
Single Ventricle Heart Disease
Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness
A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.
- Trial name
- FALD (NCT03430583)
- Testing
- Udenafil
- Where
- 17 sites in United States, Canada
- Volunteers
- 88 people
- Sponsor
- Mezzion Pharma Co. Ltd
Atrial Flutter Typical
Atrial Flutter Ablation in the iCMR
The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial.
- Trial name
- VISABL-AFL (NCT05904548)
- Testing
- RF Ablation
- Where
- 6 sites in United States, France and 2 more
- Volunteers
- 91 people
- Sponsor
- Imricor Medical Systems
Coronary Artery Disease
Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)
Participants being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study.
- Trial name
- GadaCAD 1 (NCT01890421)
- Testing
- Gadobutrol (Gadovist, Gadavist, BAY86-4875)
- Where
- 23 sites in United States, France and 5 more
- Volunteers
- 426 people
- Sponsor
- Bayer
Bradycardia, Slow Heart Beat
EMRI SureScan™ Clinical Study
The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan…
- Trial name
- NCT00433654
- Testing
- Implantable Pulse Generator (IPG) and Pacing Leads (wires), Magnetic Resonance Imaging (MRI) scan
- Where
- 45 sites in United States, Austria and 9 more
- Volunteers
- 484 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Non-valvular Atrial Fibrillation (AF)
Watchman FLX Pro CT Pilot Study
The primary objective of this study is to measure device tissue coverage post-implantation of the WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device (WATCHMAN FLX Pro) using the serial advanced imaging modalities of…
- Trial name
- NCT05567172
- Testing
- Left atrial appendage closure device WM FLX Pro
- Where
- Denmark
- Volunteers
- 43 people
- Sponsor
- Boston Scientific Corporation
Magnetic Resonance Imaging (MRI), Cardiac Pacing
Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment
The purpose of this study is to test the safety and effectiveness of the Medtronic CapSureFix Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and undergo an MRI scan.
- Trial name
- NCT01755143
- Testing
- Magnetic Resonance Imaging scan sequences of the head, neck, and chest, Pacemaker System
- Where
- 36 sites in Australia, Austria and 17 more
- Volunteers
- 266 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI
The INFINITE MRI Study is a prospective, non-randomized, multicenter, single arm study aimed at collecting data on ImageReady™ MR Conditional Pacing System (consisting of an INGENIO™ MRI or ADVANTIO™ MRI pacemaker with FINELINE™…
- Trial name
- INFINITE-MRI (NCT01890512)
- Where
- 2 sites in Netherlands
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Congenital Heart Defect
Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire
This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety and performance of magnetic resonance imaging conditional guide wire and the acceptability of identified risks in the…
- Trial name
- MRWIREPMCF (NCT02493634)
- Testing
- pressure gradient measurement, MRWire
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 25 people
- Sponsor
- Nano4Imaging GmbH