Clinical trials: Insertable Cardiac Monitor
Cryptogenic Symptomatic Transient Ischemic Attack, Cryptogenic Ischemic Stroke
Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke
The 2006 American Heart Association / American Stroke Association Council on Stroke Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic recommended that patients with cryptogenic stroke take…
- Trial name
- CRYSTAL-AF (NCT00924638)
- Testing
- Reveal® XT Insertable Cardiac Monitor
- Where
- 55 sites in United States, Austria and 12 more
- Volunteers
- 447 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent
Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study
This is a prospective, non-randomized, multi-center, real-world post-market study to collect and evaluate data regarding the performance of the enhanced atrial fibrillation detection algorithm of the Assert-IQTM Implantable…
- Conditions
- Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Cardiac Arrhythmia, Ablation
- Trial name
- Assert-IQ (NCT06172699)
- Testing
- Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device
- Where
- 11 sites in United States
- Volunteers
- 151 people
- Sponsor
- Abbott Medical Devices
Persistent Atrial Fibrillation
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial…
- Trial name
- AVANT GUARD (NCT06096337)
- Testing
- FARAPULSE™ Pulsed Field Ablation (PFA) System, Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone
- Where
- 61 sites in United States, Australia and 11 more
- Volunteers
- 484 people
- Sponsor
- Boston Scientific Corporation
Heart Failure NYHA Class II, Heart Failure NYHA Class III
Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
The ALLEVIATE-HF study is a prospective, randomized, controlled, blinded, multi-site, interventional, investigational device exemption (IDE) pivotal study.
- Trial name
- ALLEVIATE-HF (NCT04452149)
- Testing
- Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download, Medication intervention, Not Randomized to Device or Medication Intervention
- Where
- 53 sites in United States
- Volunteers
- 826 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Coronary Artery Disease
The Holding Area LINQ (Reveal LINQ Insertable Cardiac Monitor) Trial is a Prospective, Non-randomized, Single Center Post-market Clinical Trial
The Holding Area LINQ Trial is a clinical trial designed to compare the benefits in conducting impant procedures in the holding area of a hospital operating room vs cardiac catheterization/electrophysiology laboratory.
- Trial name
- HALT (NCT02493205)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Holy Cross Hospital, Florida
Arrhythmias, Cardiac
Reveal LINQ Registry
The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information.
- Trial name
- NCT02746471
- Testing
- Reveal LINQ
- Where
- 48 sites in United States, Belgium and 7 more
- Volunteers
- 1,604 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ischemic Stroke
Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke
The purpose of this study is to determine the incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation.
- Trial name
- NCT02232022
- Testing
- Reveal LINQ Insertable Cardiac Monitor
- Where
- 2 sites in United States
- Volunteers
- 53 people
- Sponsor
- Northwell Health
Atrial Fibrillation
Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors
The goal of this clinical trial is to screen all types of electrocardiographic changes and rhythm disorders in adult patients with a hematologic malignancy requiring a treatment by Bruton's tyrosine kinase (BTK) inhibitor…
- Trial name
- IRAF-ISCM (NCT06029166)
- Testing
- Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Caen
Cardiac Arrhythmias, Symptoms and Signs
Confirm Rx Insertable Cardiac Monitor SMART Registry
The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a 12 month period.
- Conditions
- Cardiac Arrhythmias, Symptoms and Signs, Atrial Fibrillation
- Trial name
- NCT03505801
- Testing
- Confirm Rx ICM insertion procedure
- Where
- 113 sites in United States, Algeria and 22 more
- Volunteers
- 1,826 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Heart Failure
Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients
Patients with heart failure (HF) represent a large population of patients who are at high risk for complications related to undiagnosed atrial fibrillation (AF).
- Trial name
- ASSERT-AF (NCT04818645)
- Testing
- ASSERT Insertable Cardiac Monitor, Conventional Management and monitoring
- Where
- United States
- Volunteers
- 477 people
- Sponsor
- University of Rochester
Hypertrophic Cardiomyopathy
Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is associated with sudden cardiac death and an increased risk of atrial fibrillation and subsequent embolic event.
- Trial name
- ElucidateHcm (NCT03259113)
- Testing
- Insertable cardiac monitor
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- Region Gävleborg
Heart Failure NYHA Class II, Heart Failure NYHA Class III
Step and Walking Pattern From Cardiac Monitor Study
To understand the feasibility of characterizing walking patterns in heart failure subjects and subjects at risk for arrhythmias using an investigational wearable monitor called the SWAN study system.
- Conditions
- Heart Failure NYHA Class II, Heart Failure NYHA Class III, Insertable Cardiac Monitor
- Trial name
- SWAN (NCT04971993)
- Testing
- Wearable Cardiac Monitor
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Tachyarrhythmia, Atrial Fibrillation
BIO.MASTER.BioMonitor 2 Study
The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is collected to support the regulatory approval of this product in countries outside the CE region.
- Conditions
- Tachyarrhythmia, Atrial Fibrillation, Syncope
- Trial name
- NCT02565238
- Testing
- BioMonitor 2
- Volunteers
- 92 people
- Sponsor
- Biotronik SE & Co. KG
Ischemic Stroke, Cerebral Infarction
Detection of Silent Atrial Fibrillation aFter Ischemic StrOke
The primary objective of this study is to evaluate whether, in patients with first-ever atherothrombotic or lacunar stroke without any previous history of atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT), the…
- Conditions
- Ischemic Stroke, Cerebral Infarction, Brain Ischemia, Brain Infarction
- Trial name
- SAFFO (NCT02684825)
- Testing
- Reveal LINQTM- LNQ11 Internal Loop Recorder plus standard cardiac monitoring
- Where
- Italy
- Volunteers
- 317 people
- Sponsor
- Danilo Toni
Heart Failure, Systolic, Heart Failure, Diastolic
Physiological Signals, Activity and Posture for Surface Mounted Insertable Cardiac Monitor in Heart Failure Study
To characterize the physiological signals collected from a Wearable Cardiac Monitor (WCM) prototype device in subjects with heart failure and preserved ejection fraction (HFpEF) and compare against signals from subjects with…
- Trial name
- HAPI-HF (NCT04112576)
- Testing
- Wearable cardiac monitor
- Where
- 3 sites in United States, Singapore and 1 more
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Syncope
LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
The LUX-Dx PERFORM Study had two primary objects which were (1) to characterize, in a general patient population, the utilization of the remote programming feature of the Boston Scientific (BSC) Insertable Cardiac Monitor (ICM)…
- Conditions
- Atrial Fibrillation, Syncope, Cryptogenic Stroke
- Trial name
- LUX-Dx PERFORM (NCT04732728)
- Where
- 24 sites in United States
- Volunteers
- 727 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Breathing Exercises
Respiration Patterns With Impedance in LINQ
The purpose of the study is to evaluate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor (ICM) as respiratory rate monitor.
- Trial name
- EPIQ (NCT02828735)
- Testing
- respiration assessment
- Where
- South Africa
- Volunteers
- 20 people
- Sponsor
- Medtronic BRC
Arrhythmias, Cardiac
Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors
Comparative analysis of available ILR devices models Abbot Confirm RxTM, Medtronic Reveal LINQTM, and Biotronik BIOMONITOR., evaluating detection performance and effective of transmission of these devices to better understand the…
- Trial name
- NCT04471584
- Testing
- Insertion of ILR device
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Kansas City Heart Rhythm Research Foundation
Arterial Hypertension, Atrial Fibrillation
Effect of Renal Denervation on Atrial Fibrillation
The purpose of the ERDAF study (Effect of Renal Denervation on Atrial Fibrillation) is to evaluate the renal sympathetic denervation in patients with resistant arterial hypertension and symptomatic paroxysmal or persistent atrial…
- Trial name
- ERDAF (NCT04055285)
- Testing
- Sympathetic Renal Denervation, Implantable Loop Recorder
- Volunteers
- 30 people
- Sponsor
- Hippocration General Hospital
Syncope, Recurrent Symptomatic Atrial Fibrillation
Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System
The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal LINQ insertable cardiac monitor and accompanying system in patients indicated for an insertable cardiac monitor
- Trial name
- NCT01965899
- Testing
- Insertable Cardiac Monitor Implant
- Where
- 16 sites in Australia, Austria and 5 more
- Volunteers
- 151 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure