N/A N=24 Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
TTR Cardiac Amyloidosis
Primary: Sudden Death — 0 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=598 Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study
Atrial Fibrillation
Primary: Number of Patients With Freedom From AF, OAC and AAD Use — 257; 185; 208; 118 Participants
N/A N=81 Monitoring in Dialysis -- a Prospective, Multi-center, Single-arm, Non-randomized, Observational Study in Patients Who Are Undergoing Hemodialysis.
End Stage Renal Disease
Primary: Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM…
N/A N=151 Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System
Syncope · Recurrent Symptomatic Atrial Fibrillation
Primary: Success of Wireless Transmissions — 73.1 percentage of successful transmissions
N/A N=75 Study of New Implantable Loop Recorder
Tachyarrhythmias · Syncope
Primary: Sensitivity for R Waves During In-Clinic Recordings at Rest — 100 percentage of recordings
N/A N=66 Reveal In-Office Implants
Arrhythmias, Cardiac
Primary: Procedure-related Complications Rate Requiring Resolution by Surgical Intervention — 2 participants
N/A N=1,999 InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry
Heart Failure · Cardiomyopathy
Primary: Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant. — 450; 213 participants
N/A N=55 Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
ACC/AHA/NASPE Class 1, IIa or IIb Indications
Primary: Conversion of Induced Ventricular Fibrillation — 52 Participants
N/A N=38 Assessing Arrhythmias After Ablation Using Implantable Recorders
Atrial Fibrillation
Primary: Arrhythmia Burden — 7; 18; 18; 5 Participants
N/A N=727 LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
Atrial Fibrillation · Syncope · Cryptogenic Stroke
Primary: ICM System-related Complication-free Rate at 30 Days Post-implant — 99.9 Percentage of participants
N/A N=195 Home Telemonitoring In Patients After Myocardial Infarction
Myocardial Infarction · Heart Attack
Primary: Emergency Room Visits — 40; 33 Emergency Room Visits
N/A N=77 BioMonitor 2 In-Office Setting Insertion Safety and Feasibility Evaluation With Device Functionality Assessment
Insertable Cardiac Monitor
Primary: Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve — 0 participants with a Primary Objective…
N/A N=521 Medtronic Reveal LINQ™ In-Office 2 (RIO 2) Study United States
Arrhythmia
Primary: Untoward Event Rate Associated With LINQ™ Insertions Performed — 2; 2 Participants — p=<0.001
N/A N=30 Electronic Device Implantation Through Remote Guidance
Telemedicine · Heart Failure · Defibrillators
Primary: Percentage of Participants With Interventional Procedures Successfully Completed — 10; 20 Participants
N/A N=24 Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
Atrial Fibrillation · Heart Failure
Primary: Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events — 5; 2; 2; 7 participants
N/A N=26 Extravascular ICD Pilot Study
Tachycardia · Ventricular Arrythmia
Primary: Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation — 18 Participants
N/A N=1,509 Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices
Arrhythmias, Cardiac
Primary: Device Malfunction — 24; 52 Participants
N/A N=1,744 REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
Device Replacement · Elective Replacement (ERI) · Device Advisory
Primary: Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With…
N/A N=400 Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)
Heart Failure
Primary: Percent of Subjects With an Attempted Implant of the Chronicle ICD System Free From System-related Chronicle ICD Complications at 6-months Post-implant. — 90.5…
N/A N=162 Detect Fluid Early From Intra-thoracic Impedance Monitoring
Heart Failure
Primary: False Positive Rate — 1.8; 1.49 departures from device threshold
N/A N=189 SJM MRI Diagnostic Imaging Registry (IDE)
Cardiac Arrhythmia
Primary: The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. — 129 MRI Scans
N/A N=49 mobiCARE™ ECG Monitoring System
ECG Monitoring
Primary: Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions — 49; 49; 49; 49 Participants
N/A N=195 Leadless Electrocardiogram (ECG) Evaluation Study
Heart Failure
Primary: Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure. — 0.99; 0.98; 0.98; 0.96 proportion
N/A N=120 Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study
Sudden Cardiac Death · Heart Failure
Primary: Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients — 14.4 milli volt (mV)
N/A N=1,064 Myocardial Infarction, COmbined-device, Recovery Enhancement Study
Acute Myocardial Infarction · Coronary Artery Disease · Acute Coronary Syndrome
Primary: Number of Participants Readmitted Within 30-days Post Hospital Discharge — 13; 145 Participants — p=0.018
N/A N=40 Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)
Stroke
Primary: Completion of Clinical Follow-up as a Measure of Feasibility — 20; 18 participants
N/A N=242 The IPED (Investigation of Palpitations in the ED) Study
Presyncope · Arrhythmias, Cardiac · Tachycardia, Supraventricular
Primary: Number of Participants With Symptomatic Rhythm Detection up to 90 Days — 69; 11 Participants
N/A N=167 Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
Tachyarrhythmia · Atrial Fibrillation (AF) · Syncope
Primary: SADE-free Rate Until the 3-month Follow-up — 141 Participants — p=0.05
N/A N=446 REVEAL AF: Incidence of AF in High Risk Patients
Atrial Fibrillation
Primary: 18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes — 29.3 percent of participants
N/A N=128 Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds
Heart Failure · Ventricular Arrythmias
Primary: Percentage of Participants Free of System-related Complications at 3-months Post Implant — 93.6 Percentage of Participants