Clinical trials: Implantable Cardiac Monitor
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
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
TTR Cardiac Amyloidosis
Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
Researchers are gathering information to see if using an FDA approved implantable device can help with monitoring of your heart arrhythmias.
- Trial name
- NCT04421040
- Testing
- Biotronik Biomonitor 3 implant of device, Biotronik Biomonitor 3 explant of device
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Mayo Clinic
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
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
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, 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
Postoperative Atrial Fibrillation
Multiparametric MRI Assessment of Atrial Heart Disease as a Predictor of Atrial Fibrillation After Myocardial Revascularization Surgery
Postoperative atrial fibrillation (POAF) occurs in 20-40% of patients undergoing coronary artery bypass grafting (CABG) and is a marker of atrial vulnerability.
- Trial name
- IRM-FAPO (NCT04657835)
- Testing
- 4D cardiac MRI with gadoteric acid, Blood sample, Implantable Loop Recorder (ILR)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Atrial Fibrillation, Heart Failure
"De Novo" Atrial Fibrillation in Patients With Heart Failure: Incidence; Predictors and Relevance.
Atrial fibrillation (AF) represents a problem of great implications to patients with heart failure (HF). Therefore, the risk of having AF increases up to 4,5 -5,9 times with the presence of HF.
- Trial name
- FAISCA (NCT04755010)
- Testing
- Linq II implantable cardiac monitor
- Where
- Spain
- Volunteers
- 300 people
- Sponsor
- Hospital Clinico Universitario de Santiago
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
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
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
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
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
Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation
The objective is to compare the progression of Atrial Fib (AF) burden by continuous monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation (PVI) versus anti-arrhythmic drug (AAD) therapy.
- Trial name
- CABAL (NCT01505296)
- Testing
- Antiarrhythmic drug, Catheter ablation
- Where
- 2 sites in United States, Russia
- Sponsor
- Valley Health System
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
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