Clinical trials: Implantable Cardiac Monitor
Ischemic Stroke, Ischemia
Biomarkers of Acute Stroke in Clinic
The proposed study will investigate the clinical use of the ISCDX test that may differentiate between diverse stroke etiologies as listed below: Aim 1: Differentiate between cardioembolic and large artery atherosclerotic ischemic…
- Conditions
- Ischemic Stroke, Ischemia, Atrial Fibrillation, Transient Ischemic Attack
- Trial name
- BASIC (NCT03897478)
- Testing
- ISCDX blood test
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Ischemia Care LLC
Heart Failure, Defibrillators, Implantable
Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an…
- Conditions
- Heart Failure, Defibrillators, Implantable, Monitoring, Physiologic, Cardiac Resynchronization Therapy
- Trial name
- PREEMPT-HF (NCT03579641)
- Testing
- HeartLogic Sensors
- Where
- 88 sites in United States, Australia and 11 more
- Volunteers
- 2,184 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart Failure Management
The objective of the HARMONY trial is to evaluate the safety and efficacy of implantable left atrial pressure sensor and interatrial shunt system for the treatment of chronic heart failure with reduced left ventricular ejection…
- Trial name
- NCT07402239
- Testing
- NOVAtria System, Control
- Where
- 15 sites in China
- Volunteers
- 330 people
- Sponsor
- United Innomed(Shanghai) Limited
Arrhythmia, Syncope
Feasibility Study: Sleuth Monitoring System
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.
- Trial name
- PULSE (NCT00719277)
- Testing
- Sleuth Implantable ECG Monitoring System
- Where
- Panama
- Volunteers
- 40 people
- Sponsor
- Transoma Medical
Atrial Fibrillation
DEFINE AFib (Atrial Fibrillation)
DEFINE AFib is a prospective, observational, post-market clinical study administered to patients via the Medtronic Discovery app platform.
- Trial name
- DEFINE AFib (NCT04926857)
- Testing
- Non-Interventional
- Where
- 26 sites in United States
- Volunteers
- 973 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Tachycardia, Atrial Fibrillation
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up.
- Conditions
- Tachycardia, Atrial Fibrillation, Syncope, Bradycardia
- Trial name
- BIOSTREAM-ICM (NCT04075084)
- Where
- 31 sites in Australia, Czechia and 7 more
- Volunteers
- 1,400 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation, Syncope
BIO|CONCEPT.BIOMONITOR III
The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the…
- Conditions
- Atrial Fibrillation, Syncope, Tachyarrhythmia
- Trial name
- NCT03850327
- Testing
- BIOMONITOR III
- Where
- 7 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Biotronik SE & Co. KG
Tachyarrhythmias, Syncope
Study of New Implantable Loop Recorder
The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor (device).
- Trial name
- NCT00746564
- Testing
- SJM Confirm
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Abbott Medical Devices
Cryptogenic Stroke
Cryptogenic Stroke Study
The purpose of this study is to determine whether the Sleuth Implantable Loop Recorder will enhance detection of latent atrial fibrillation in patients after cryptogenic stroke.
- Trial name
- NCT00861133
- Testing
- Sleuth AT Implantable ECG Monitoring System
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Transoma Medical
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 Diseases
ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices
The registry is an international, multicenter, non-randomized, non-invasive study to assess the safety, performance and usability of the Occlutech Accessories "Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP)…
- Trial name
- NCT05174442
- Where
- 36 sites in Germany, Turkey (Türkiye)
- Volunteers
- 685 people
- Sponsor
- Occlutech International AB
Heart Failure, Left-Sided Heart Failure
CardioMEMS HF System Post Approval Study
The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.
- Conditions
- Heart Failure, Left-Sided Heart Failure, Congestive Heart Failure
- Trial name
- NCT02279888
- Testing
- CardioMEMS HF System
- Where
- United States
- Volunteers
- 1,214 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM) and pressure sensor lead.
- Trial name
- NCT00643279
- Testing
- Chronicle Implantable Hemodynamic Monitor, Standard of Care
- Where
- 28 sites in United States
- Volunteers
- 277 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy
The purpose of this clinical study is to evaluate the safety and clinical effectiveness of use of a physician-directed, patient self-management system, guided by left atrial pressure measurements, for use in patients with heart…
- Trial name
- LAPTOP-HF (NCT01121107)
- Testing
- Left Atrial Pressure Monitoring System, Patient Advisory Module
- Where
- 64 sites in United States, New Zealand
- Volunteers
- 486 people
- Sponsor
- Abbott Medical Devices
ATRIAL FIBRILLATION, Syncope
BioMonitor Master Study
The BioMonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation.
- Trial name
- BioMonitor (NCT01725568)
- Testing
- BioMonitor
- Where
- Germany
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Chagas Disease, Heart Diseases
Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients With Chagas Disease
The study "Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients with Chagas Disease" is a prospective, multicenter, randomized study that is being conducted at several centers in Latin America with…
- Trial name
- NCT01539161
- Testing
- Implantable Cardiac Monitor, Standard of Care
- Where
- 4 sites in Argentina, Colombia
- Volunteers
- 12 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure