Clinical trials: Implantable Cardiac Monitor
Atrial Fibrillation
Radiofrequency vs Cryoballoon Ablation for Atrial Fibrillation Assessed by Implantable Cardiac Monitor
The study is a prospective randomized comparison of two methods of catheter ablation of atrial fibrillation: Radiofrequency ablation which is the standard of care will be compared to Cryoballoon ablation to perform pulmonary vein…
- Trial name
- RACE-AF (NCT03805555)
- Testing
- Radiofrequency ablation, Cryoballoon ablation
- Where
- Denmark
- Volunteers
- 105 people
- Sponsor
- University Hospital, Gentofte, Copenhagen
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
Atrial Fibrillation
Comparison of External Event Recorders for Atrial Fibrillation Monitoring
Ablation of atrial fibrillation is a well established treatment method to restore normal sinus rhythm and eliminate the need for continued antiarrhythmic therapy and anticoagulation.
- Trial name
- NCT00863382
- Testing
- Standard Event Monitor, Sleuth Monitor
- Where
- United States
- Sponsor
- Dhanunjaya Lakkireddy, MD, FACC
Embolic Stroke of Undetermined Source
AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM
This study investigates patients with Embolic Stroke of Undetermined Source (ESUS) who have received an Implantable Cardiac Monitor (ICM).
- Trial name
- SMART-ESUS (NCT07347691)
- Where
- 5 sites in South Korea
- Volunteers
- 92 people
- Sponsor
- Inha University Hospital
Atrial Fibrillation, Stroke
Follow-up of Kryptogenic Stroke Patients With Implantable vs. Non-invasive Devices to Detect Atrial Fibrillation.
Prospective mono-center diagnostic study determining potential discrepancies in identifying atrial fibrillation by intraindividually comparing different types of follow-up strategies: 1.
- Trial name
- TRACK-AF (NCT02641678)
- Testing
- Implantation of cardiac monitor
- Volunteers
- 106 people
- Sponsor
- University Hospital Muenster
Atrial Fibrillation, Supraventricular Arrhythmia
Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors
This study will enroll patients initiating Bruton Tyrosine Kinase (BTK) inhibitors without history of documented arrhythmia while on therapy using the Medtronic LINQ-2 insertable cardiac monitor (ILR).
- Conditions
- Atrial Fibrillation, Supraventricular Arrhythmia, Ventricular Arrhythmias and Cardiac Arrest, Chronic Lymphocytic Leukemia
- Trial name
- NCT05643235
- Testing
- Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Northwell Health
Atrial Fibrillation
Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study
Observational, multi-center, retrospective study to evaluate the use of ICM (implantable cardiac monitor) versus traditional, non-ICM (non-implantable cardiac monitor) methods such as ECGs (electrocardiogram), Holter, and mobile…
- Trial name
- NCT06352060
- Testing
- No intervention or administration will be performed due to the observational nature of the study
- Where
- 7 sites in United States
- Volunteers
- 598 people
- Sponsor
- Kansas City Heart Rhythm Research Foundation
Cardiac Arrythmias, Syncope
Confirm Rx™ Versus Reveal LINQ™ - Which is More Reliable in Data Transmission? A Randomized Clinical Study
This study will compare the reliability and timeliness in data transmission of the Abbott Confirm Rx™ loop recorder with the Medtronic Reveal LINQ™ loop recorder.
- Conditions
- Cardiac Arrythmias, Syncope, Atrial Fibrillation, Atrial Flutter
- Trial name
- NCT03720639
- Testing
- Abbott, Inc Confirm Rx™ versus Medtronic, Inc Reveal LINQTM
- Where
- 2 sites in United States
- Volunteers
- 209 people
- Sponsor
- Sparrow Clinical Research Institute
Atrial Fibrillation, Overweight and Obesity
Semaglutide for the Reduction of Arrhythmia Burden in Overweight AF Patients
The purpose of this pilot study is to assess the feasibility of a double-blind, randomized placebo-controlled trial of semaglutide 2.4 mg subcutaneously once weekly on top of standard care compared to standard care alone.
- Trial name
- SOCRATES-AF (NCT04885634)
- Testing
- Semaglutide Injectable Product
- Sponsor
- Axel Brandes
Persistent Atrial Fibrillation
Evaluation of the Efficacy of Pulmonary Vein Isolation by Pulsed-field Ablation in Persistent Atrial Fibrillation: a Multicenter Study With Follow-up by Implantable Cardiac Monitor
Atrial fibrillation (AF) is the most common sustained arrhythmia in adult population. According to current guidelines for the management of AF, radiofrequency (RF) ablation (including at least pulmonary vein isolation [PVI]) is a…
- Trial name
- PersAF ICM (NCT06985901)
- Testing
- Persistent atrial fibrillation ablation using Pulsed-field ablation
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
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
Paroxysmal Atrial Fibrillation, Cardiac Rhythm Disorder
Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke
Cryptogenic stroke (CS) causes about 30% of admissions to a stroke unit. Silent paroxysmal atrial fibrillation (PAF) is believed to be the underlying cause of a significant proportion of patients.
- Conditions
- Paroxysmal Atrial Fibrillation, Cardiac Rhythm Disorder, Left Atrial Dilatation, Cryptogenic Stroke
- Trial name
- CRIPTO-FAST (NCT06542770)
- Testing
- Early implant of cardiac monitor
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Parc de Salut Mar
Obstructive Sleep Apnea, Cardiovascular Diseases
Obstructive Sleep Apnoea and Cardiac Arrhythmias
This study is a prevelance trial looking at how sleep apnoea affects the heart especially heart rhythms. Previous research shows that patients suffering from sleep apnoea are much more likely to get heart disease and abnormal…
- Conditions
- Obstructive Sleep Apnea, Cardiovascular Diseases, Arrhythmia, Atrial Fibrillation New Onset
- Trial name
- OSCA (NCT03866148)
- Testing
- Reveal LINQ
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
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
Effects of Catheter Ablation on Burden of Atrial Fibrillation (MRICEMAN)
The study will assess the atrial fibrillation burden recorded By implantable loop recorder at 12 and 24 months compared to baseline.
- Trial name
- MRICEMAN (NCT02639793)
- Testing
- catheter ablation
- Where
- 2 sites in Finland
- Volunteers
- 300 people
- Sponsor
- Heikki Huikuri
Congestive Heart Failure
Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices
A relatively new and promising development in the area of cardiovascular implantable electronic device therapy is remote patient monitoring (RPM).
- Trial name
- REMOTE-CIED (NCT01691586)
- Testing
- Remote patient monitoring, In-Clinic check-ups
- Where
- Netherlands
- Volunteers
- 600 people
- Sponsor
- UMC Utrecht
Atrial Fibrillation
Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation
The investigators hypothesized that very lenient rate control is not inferior to strict or lenient rate control assessed by implantable continuous ECG monitor for preventing cardiovascular hospitalization and mortality in…
- Trial name
- REVEAL (NCT01444573)
- Testing
- implantable continuous monitor
- Where
- Russia
- Volunteers
- 90 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
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
Stroke, Implantation of an Implantable Cardiac Monitor
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Atrial fibrillation is a cardiac arrhythmia most often originating in the left atrium, causing anarchic electrical activity and thus a loss of atrial contraction.
- Trial name
- FIBROSIS-MRI (NCT06047782)
- Testing
- Cardiac MRI (with contrast agent)
- Where
- France
- Volunteers
- 157 people
- Sponsor
- Centre Hospitalier Universitaire Dijon