Clinical trials: Arrythmia, Cardiac
- Condition Arrythmia, Cardiac
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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
Arrhythmia, Bradycardia
CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
This study compares the pacemaker's automatic pacing threshold measurements to the manual measurements conducted by a health care provider.
- Trial name
- NCT00275769
- Testing
- Pacemaker
- Where
- 57 sites in United States, Canada
- Volunteers
- 860 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Paroxysmal Atrial Fibrillation
Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation
The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory…
- Trial name
- NEwTON AF (NCT04580914)
- Testing
- Treatment with IntellaNav StablePoint Ablation Catheter
- Where
- 47 sites in United States, Austria and 11 more
- Volunteers
- 321 people
- Sponsor
- Boston Scientific Corporation
Cardiomyopathies, Cardiac Arrest
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
WILLEM is a multi-center, prospective and retrospective cohort study. The study will assess the performance of a cloud-based and AI-powered ECG analysis platform, named Willem™, developed to detect arrhythmias and other abnormal…
- Conditions
- Cardiomyopathies, Cardiac Arrest, Cardiac Arrhythmias, Sudden Cardiac Death
- Trial name
- WILLEM (NCT05890716)
- Testing
- AI-powered ECG analysis to detect cardiac arrhythmic episodes
- Where
- 13 sites in Netherlands, Spain
- Volunteers
- 5,342 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Ventricular Fibrillation, Ventricular Tachycardia
Left Ventricular Capture Management Study
Primary Objective: To characterize left ventricular (LV) threshold behavior over time using daily left ventricular capture management (LVCM) measurements.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia, Bradyarrhythmia
- Trial name
- LEARN (NCT01089634)
- Where
- Canada
- Volunteers
- 151 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Adverse Effect of MRI on an Implanted Pacemaker Lead, Adverse Effect of MRI on an Implanted Pacemaker
Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI…
- Trial name
- NCT01576016
- Testing
- Accent MRI system (lead safety), Accent MRI system (with MRI scan)
- Where
- 70 sites in United States, Australia and 3 more
- Volunteers
- 950 people
- Sponsor
- Abbott Medical Devices
Sudden Cardiac Death
Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
- Trial name
- Prediction (NCT00560768)
- Testing
- Ovatio VR 6250 or DR6550
- Where
- 30 sites in United States, Canada and 2 more
- Volunteers
- 198 people
- Sponsor
- LivaNova
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
Atrial Fibrillation
Topera C-FIRM Registry
This is a control registry to the E-FIRM registry to track conventional atrial fibrillation (AF) procedures in terms of clinical usage, handling, and the safety and effectiveness for the treatment of symptomatic atrial…
- Trial name
- NCT02407249
- Where
- 9 sites in Germany, Netherlands
- Volunteers
- 73 people
- Sponsor
- Abbott Medical Devices
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 (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
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
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
Arrhythmia, Bradycardia
MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY
The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices.
- Trial name
- NCT01076374
- Where
- 129 sites in United States, Austria and 10 more
- Volunteers
- 2,927 people
- Sponsor
- Medtronic
Cardiac Rhythm Disorder
EP Device Registry
This study will provide ongoing, high quality data on the safety, performance, and clinical benefits of Abbott's EP devices in a real-world setting.
- Trial name
- NCT04460209
- Testing
- Standard of Care
- Where
- 26 sites in Austria, Czechia and 8 more
- Volunteers
- 5,003 people
- Sponsor
- Abbott Medical Devices
Arrhythmias, Cardiac
An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense…
- Trial name
- SECURE (NCT04750798)
- Testing
- BWI Medical Device, Varipulse Catheter, Dual Energy THERMOCOOL SMARTTOUCH SF Catheter
- Where
- 47 sites in Austria, Belgium and 13 more
- Volunteers
- 8,000 people
- Sponsor
- Biosense Webster, Inc.
Neonates
NICU-TECH RM9L-RS Probe ME Feasibility Study
Use of a new ultrasound device designed for babies to look at the catheters in veins and arteries as well as the blood vessel itself.
- Trial name
- NCT01181596
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- GE Healthcare
Atrial Fibrillation, Bradycardia
Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class
This registry is a data collection on patients who are implanted for more than 6 months with a pacemaker. Frequency and distribution of right ventricular pacing, NYHA class and left ventricular ejection fraction shall be…
- Conditions
- Atrial Fibrillation, Bradycardia, Heart Block, Sick Sinus Syndrome
- Trial name
- NCT00292539
- Testing
- Any pacemaker with right ventricular pacing option
- Where
- Germany
- Volunteers
- 600 people
- Sponsor
- Guidant Corporation
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
Atrial Fibrillation
Japanese Pradaxa PMS, Long Term
The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab
- Trial name
- NCT03175198
- Testing
- Prazaxa® Capsules
- Where
- Japan
- Volunteers
- 5,660 people
- Sponsor
- Boehringer Ingelheim