Clinical trials: Arrhythmia
Cardiac Arrhythmia
Qualitative Analysis of Photoplethysmography Waveforms for the Detection of Cardiac Arrhythmias
Single-lead electrocardiography (ECG) technologies and photoplethysmography (PPG) deriving smartphone apps are gaining interest in the heart rhythm detection space since these apps have the potential to capture and assess heart…
- Trial name
- INTERPRET-AF I (NCT04374344)
- Testing
- Qualitative analysis of PPG, single-lead ECG, and 12-lead ECG measurements
- Where
- Belgium
- Volunteers
- 76 people
- Sponsor
- Qompium NV
Ventricular Tachycardia, Ventricular Fibrillation
DF4 Connector System Post-Approval Study
The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT01638897
- Where
- 78 sites in United States, Canada and 1 more
- Volunteers
- 1,778 people
- Sponsor
- Medtronic
Heart Failure, Congestive, Ventricular Fibrillation
Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation
The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.
- Conditions
- Heart Failure, Congestive, Ventricular Fibrillation, Tachycardia, Ventricular
- Trial name
- NCT00387803
- Testing
- Cardiac Resynchronization Therapy with Defibrillation
- Where
- United States
- Volunteers
- 581 people
- Sponsor
- Boston Scientific Corporation
Tachyarrhythmia
Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study
Following product approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained…
- Trial name
- NCT02849769
- Testing
- Implant of an MR-conditional Tachy device system
- Volunteers
- 10,979 people
- Sponsor
- Medtronic
Tachyarrhythmia
Lead Evaluation for Defibrillation and Reliability Post Approval Study
Medtronic is sponsoring the LEADR PAS to provide continuing evaluation and periodic reporting of safety and effectiveness of the OmniaSecure™ defibrillation lead following commercial release.
- Trial name
- LEADR PAS (NCT07005232)
- Testing
- defibrillation lead
- Where
- 97 sites in United States, Austria and 7 more
- Volunteers
- 2,000 people
- Sponsor
- Medtronic
Ventricular Tachyarrhythmia
Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead. The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD…
- Trial name
- NCT04863664
- Testing
- Defibrillation (RV Implant), Defibrillation (LBBAP Implant)
- Where
- 55 sites in United States, Australia and 18 more
- Volunteers
- 1,007 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Pacemaker, Bradycardia
Adapta Pacing System Clinical Study
Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow).
- Trial name
- NCT00307073
- Testing
- Implantable Pulse Generator
- Where
- 7 sites in Austria, Czechia and 4 more
- Volunteers
- 120 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Bradycardia
Study for Atrial Fibrillation Reduction (SAFARI)
Atrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the heart, is the world's most common kind of irregular heart beat.
- Trial name
- NCT00267137
- Testing
- Pacing Algorithms
- Where
- 34 sites in United States
- Volunteers
- 540 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Acute Coronary Syndrome, Venous Thrombosis
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Sweden)
This prospective cohort study will provide information about: Characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed standard of care for the first…
- Conditions
- Acute Coronary Syndrome, Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation
- Trial name
- NCT02468102
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of care drugs
- Where
- Sweden
- Volunteers
- 99,999 people
- Sponsor
- Bayer
Heart Failure, Cardiac Arrhythmia
MediGuide Registry
The goal of this registry/observational study is to collect data on the clinical utility of MediGuide™ system in cardiac resynchronization therapy (CRT) implantation and electrophysiology (EP) procedures.
- Trial name
- NCT02470312
- Testing
- CRT implantation, MediGuide, EP
- Where
- 16 sites in United States, Australia and 6 more
- Volunteers
- 578 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
The purpose of the study is to compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for Stroke…
- Trial name
- BROTHER (NCT02864758)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonists, dabigatran (Pradaxa)
- Where
- France
- Volunteers
- 99,999 people
- Sponsor
- Bayer
Alzheimer's Disease
A Cardiac Safety Study of Galantamine in the Treatment of Alzheimer's Disease.
The objective of this trial was to investigate the effect of galantamine (an acetylcholinesterase inhibitor) on heart rate and PR interval (the time it takes for the heart's electrical impulse to get from the atria to the…
- Trial name
- NCT00309725
- Testing
- galantamine
- Volunteers
- 139 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ventricular Tachycardia, Ventricular Fibrillation
DAVID II (Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial II)
The DAVID II Clinical Study evaluates the hypothesis that, in patients needing an ICD but without overt indications for pacing, AAI pacing with maximal concomitant drug therapy will not increase the rate of the combined endpoint…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Congestive Heart Failure
- Trial name
- DAVIDII (NCT00187187)
- Testing
- Implantable Defibrillator (ICD)
- Volunteers
- 600 people
- Sponsor
- Abbott Medical Devices
Bradycardia
SureScan Post-Approval Study
The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling.
- Trial name
- NCT01299675
- Where
- 61 sites in United States, Canada
- Volunteers
- 2,483 people
- Sponsor
- Medtronic
Bradycardia, Slow Heart Beat
EMRI SureScan™ Clinical Study
The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan…
- Trial name
- NCT00433654
- Testing
- Implantable Pulse Generator (IPG) and Pacing Leads (wires), Magnetic Resonance Imaging (MRI) scan
- Where
- 45 sites in United States, Austria and 9 more
- Volunteers
- 484 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Topera E-FIRM Registry
This is a registry to assess the safety and effectiveness of FIRM guided procedures for the treatment of symptomatic any type of atrial fibrillation.
- Trial name
- NCT02386345
- Where
- 9 sites in Germany, Netherlands
- Volunteers
- 299 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation (AF)
COCONUT Study Concomitant PVI and LAAC
In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and…
- Trial name
- COCONUT (NCT06861673)
- Testing
- Pulmonary vein isolation
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Asklepios proresearch
Arrhythmia, Cardiac
Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development
Record cutaneous Electrocardiogram (ECG) data from positions corresponding to the expected subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using existing, approved ECG recording devices.
- Trial name
- NCT02991716
- Testing
- recorded patients
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- NewPace Ltd
Arrhythmia, Bradycardia
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival…
- Conditions
- Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia
- Trial name
- PPR (NCT00271180)
- Testing
- Device
- Where
- 338 sites in United States, Australia and 33 more
- Volunteers
- 20,000 people
- Sponsor
- Medtronic
Atrial Fibrillation
Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe
This is a descriptive, observational, multi-country European cross-sectional study of new users of dabigatran etexilate that aims to characterise on- and off-label status and other medical characteristics at the time of the first…
- Trial name
- NCT02240654
- Where
- Spain
- Volunteers
- 36,573 people
- Sponsor
- Boehringer Ingelheim