Clinical trials: Insertable Cardiac Monitor
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
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
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
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
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
Insertable Cardiac Monitor
BioMonitor 2 In-Office Setting Insertion Safety and Feasibility Evaluation With Device Functionality Assessment
The purpose of this study is to evaluate the safety and feasibility of performing the BioMonitor 2 insertion procedure in an office setting.
- Trial name
- BioInsight (NCT02756338)
- Testing
- BioMonitor 2 Insertable Cardiac Monitor
- Where
- 6 sites in United States
- Volunteers
- 77 people
- Sponsor
- Biotronik, Inc.
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
Heart Failure
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
- Trial name
- NCT04790344
- Testing
- Investigational LUX-Dx ICM Implant
- Where
- 57 sites in United States
- Volunteers
- 557 people
- Sponsor
- Boston Scientific Corporation
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
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
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
Arrhythmias, Cardiac, Atrial Fibrillation
Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-in-Human Study)
This study is a first-in-human, prospective, multi-center, pre-market single-arm clinical trial to evaluate the Future Cardia™ ICM.
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Bradycardia, Ventricular Tachycardia
- Trial name
- NCT06167434
- Testing
- Future Cardia™ Insertable Cardiac Monitoring (ICM) System
- Where
- Croatia
- Volunteers
- 30 people
- Sponsor
- Future Cardia, Inc
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
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