Clinical trials: Magnetic Resonance Imaging (MRI); Cardiac Pacing
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
Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the…
- Conditions
- Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM), Restrictive Cardiomyopathy
- Trial name
- AINICM (NCT06607471)
- Testing
- Support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation, Support treatment, cardiac medical treatment, aetiology-specific treatment
- Where
- Italy
- Volunteers
- 15,000 people
- Sponsor
- Scientific Institute San Raffaele
Heart Failure, Systolic
Effects of CRT Optimization as Assessed by Cardiac MR
Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical…
- Trial name
- NCT04763460
- Testing
- Programming of CRT device settings
- Where
- 2 sites in United States
- Sponsor
- Minneapolis Heart Institute Foundation
Heart Failure, AV Block
Synchrony in Cardiac Conduction: Assessing the Effects of Pacing on Cardiac Performance Through Magnetic Resonance Imaging and Advanced ECG-imaging
Rationale Right ventricular pacing (RVP) is an established and effective therapy for patients with atrioventricular (AV) block. However, frequent RVP has been associated with left ventricular (LV) dyssynchrony and may progess…
- Trial name
- HARMONY (NCT06843135)
- Testing
- Ventricular pacing
- Volunteers
- 88 people
- Sponsor
- Amsterdam UMC, location VUmc
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
Heart Failure, Left Ventricular Dysfunction
Predicting Response to Cardiac Resynchronization Therapy in Heart Failure
This study will explore which characteristics of patients with heart failure will likely predict improvement after cardiac resynchronization (CRT), implantation of a pacemaker to improve heart function.
- Trial name
- NCT00359372
- Where
- 3 sites in United States
- Volunteers
- 180 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Cardiac Rhythm Disorder
3T MRI CIED Post-Approval Study
The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure.
- Trial name
- NCT02969395
- Where
- 204 sites in United States, Belgium and 20 more
- Volunteers
- 41 people
- Sponsor
- Medtronic
Magnetic Resonance Imaging (MRI); Cardiac Pacing
ProMRI Study of the Entovis Pacemaker System (Phase B)
The objective of the ProMRI Study (Phase B) is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone.
- Trial name
- NCT02009696
- Testing
- Patients with a ProMRI Pacemaker System, Magnetic Resonance Imaging (MRI) scan
- Where
- 32 sites in United States
- Volunteers
- 221 people
- Sponsor
- Biotronik, Inc.
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
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
Systolic Heart Failure, Dysynchrony
Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy
This randomized controlled trial will assess a cardiac MRI derived 4D digital cardiac model to optimized left and right ventricular lead delivery to improve response to cardiac resynchronization therapy.
- Conditions
- Systolic Heart Failure, Dysynchrony, Image Guidance, Digital Twins
- Trial name
- NCT01640769
- Testing
- 4D Model guided delivery of cardiac pacing leads, Standard CRT lead delivery
- Where
- 5 sites in Canada
- Volunteers
- 210 people
- Sponsor
- Libin Cardiovascular Institute of Alberta
Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs
ProMRI PROVEN Master Study
This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker…
- Trial name
- NCT01809665
- Testing
- ICD/CRT-P therapy, MRI
- Where
- 23 sites in Australia, Austria and 6 more
- Volunteers
- 174 people
- Sponsor
- Biotronik SE & Co. KG