Clinical trials: Arrythmia, Cardiac
Atrial Fibrillation, Atrial Flutter
A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke
The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of…
- Trial name
- GUARD-AF (NCT04126486)
- Testing
- Zio®XT Monitor
- Where
- 176 sites in United States
- Volunteers
- 11,931 people
- Sponsor
- Bristol-Myers Squibb
Coronary Arteriosclerosis, Atrial Fibrillation
A(f)MAZE-CABG Study
Concomitant AF ablation with HIFU in patients with persistent or long standing persistent AF undergoing CABG will be superior in restoring SR, compared with patients with persistent or long standing persistent AF undergoing CABG…
- Conditions
- Coronary Arteriosclerosis, Atrial Fibrillation, Coronary Artery Bypass Graft Surgery
- Trial name
- AFMAZE-CABG (NCT00735722)
- Testing
- HIFU AF Ablation
- Where
- 10 sites in Canada, Finland and 4 more
- Volunteers
- 188 people
- Sponsor
- Abbott Medical Devices
Arrhythmias, Cardiac, Atrial Fibrillation and Flutter
Aino ECG Ambulatory Study
The study includes collection of data from patients referred to a therapeutic evaluation in Tays Sydänkeskus Oy (Heart Center Co, Tampere University Hospital) or another unit of Sydänkeskus (hereafter the Heart Hospital) due to…
- Trial name
- NCT05008601
- Testing
- Wrist-word optical heart rate and ECG measurement device
- Where
- Finland
- Volunteers
- 31 people
- Sponsor
- PulseOn Oy
Anticoagulant Therapy
In Vitro Diagnostic Test for DOAC in Urine
This trial is conducted to assess the performance and handling of the in vitro diagnostic (IVD) device for oral direct factor Xa and thrombin inhibitors from urine samples of patients on treatment with direct oral anticoagulants…
- Trial name
- PADOASU (NCT03182829)
- Testing
- DOAC Dipstick
- Where
- 18 sites in Germany
- Volunteers
- 880 people
- Sponsor
- Doasense GmbH
Atrial Fibrillation
Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy
Primary Objective: Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization…
- Trial name
- PALLAS (NCT01151137)
- Testing
- Dronedarone
- Where
- 37 sites in United States, Argentina and 35 more
- Volunteers
- 3,236 people
- Sponsor
- Sanofi
Arrhythmias, Cardiac
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
The purpose of this study is to collect information about how safe Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter with TRUPULSE™ Generator is and how effective a specific procedural workflow is when this ablation system…
- Trial name
- DEVA (NCT07727057)
- Testing
- Radiofrequency/Pulsed Field Ablation System
- Where
- 6 sites in Austria, Belgium and 1 more
- Volunteers
- 90 people
- Sponsor
- Biosense Webster, Inc.
Fibrillation, Atrial
Evaluation of Fondaparinux in Patients With a Heart Rhythm Disturbance Who Undergo Restoration of Normal Heart Rhythm
The purpose of this study is to test whether Fondaparinux is effective and safe to prevent thromboembolic events (like for example strokes) and bleeding events in patients who undergo a normalisation of their heart rhythm…
- Trial name
- NCT00911300
- Testing
- fondaparinux, unfractionated heparin, Vitamin-K-Antagonist
- Where
- 34 sites in France, Germany
- Volunteers
- 349 people
- Sponsor
- GlaxoSmithKline
Atrial Fibrillation
Safety & Clinical Performance Study of Catheter Ablation With the Centauri System for Patients With Atrial Fibrillation
This study is a prospective, single-arm, open-label study following patients to 1 year, to evaluate the safety and performance of the Centauri System for catheter ablation of atrial fibrillation (AF).
- Trial name
- ECLIPSE AF (NCT04523545)
- Testing
- cardiac ablation
- Where
- Croatia
- Volunteers
- 200 people
- Sponsor
- Galaxy Medical, Inc.
Sick Sinus Syndrome, Brady-Tachy Syndrome
Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation
The objective of this trial is to show the therapeutic efficacy of the preventive pacing therapies of the Selection 9000 and Vitatron T70 DR pacemakers, dedicated to handle atrial fibrillation (AF).
- Trial name
- NCT00224341
- Testing
- Pacemaker Vitatron Selection 9000, Pacemaker Vitatron T70
- Where
- 37 sites in France
- Volunteers
- 360 people
- Sponsor
- Vitatron France
Paroxysmal Atrial Fibrillation
Evaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)
The purpose of this clinical trial is to evaluate the safety and efficacy of a pulsed field ablation system developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd in the treatment of patients with paroxysmal atrial…
- Trial name
- NCT05114954
- Testing
- CardioPulsesTM pulsed field ablation system
- Where
- China
- Volunteers
- 158 people
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd
Arrhythmias, Cardiac
The MAGiC™ Cardiac Ablation European Study
The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval.
- Trial name
- MAGiC-FESTPMCF (NCT06019845)
- Testing
- MAGiC™
- Where
- 4 sites in Denmark, Lithuania and 2 more
- Volunteers
- 150 people
- Sponsor
- Stereotaxis
Atrial Fibrillation
Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes
Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically and irregularly, out of coordination with the two lower chambers (called ventricles) of the heart.
- Trial name
- NCT02964949
- Testing
- Edoxaban
- Where
- 233 sites in Belgium, Bulgaria and 13 more
- Volunteers
- 607 people
- Sponsor
- Daiichi Sankyo
Atrial Fibrillation
Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)
This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.
- Trial name
- PRECEPT (NCT02817776)
- Testing
- THERMOCOOL SMARTTOUCH® SF catheter
- Volunteers
- 381 people
- Sponsor
- Biosense Webster, Inc.
Tachycardia, Heart Failure
BIO|CONCEPT.CorSky, First in Human Study for the CorSky ICD Family
The goal of this exploratory study is to test the preliminary safety and product performance of the new CorSky ICD family in subjects that require an ICD or cardiac resynchronization therapy with defibrillation (CRT-D).
- Trial name
- NCT06840509
- Testing
- CorSky ICD or CRT-D
- Where
- Australia
- Volunteers
- 52 people
- Sponsor
- Biotronik Australia Pty Ltd.
Severe Respiratory Syncytial Virus Infection
Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease
Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that…
- Trial name
- NCT01075178
- Where
- 37 sites in Austria, Belgium and 8 more
- Volunteers
- 2,036 people
- Sponsor
- Abbott
Tachyarrhythmias, Atrial Fibrillation
OptiSense™ Performance in Detecting Atrial Episodes
The SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave (FFRW).
- Trial name
- SENSE-AF (NCT00870324)
- Testing
- OptiSense Lead, Tendril Lead
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
RandOmised Controlled Trial of STAR Mapping™ Guided Ablation for AF.
Atrial fibrillation (AF) is the most common arrhythmia with an expected rise in prevalence over the next decade. Beyond causing troublesome symptoms AF is associated with increased mortality and morbidity.
- Trial name
- ROC-STAR (NCT04442113)
- Testing
- Pulmonary vein isolation plus ablation guided by novel STAR mapping™, Pulmonary vein isolation
- Sponsor
- Rhythm AI Ltd
Atrial Fibrillation
PulseSelect™ PFA Global Registry
The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.
- Trial name
- NCT06393920
- Where
- 43 sites in Australia, Belgium and 14 more
- Volunteers
- 1,950 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Cardiac Arrhythmia
An Evaluation of the Safety and Performance of the CathVision ECGenius® System.
The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available…
- Trial name
- NCT05301803
- Testing
- Electrophysiology procedure
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- CathVision ApS
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
BIO|MASTER.CSP Study
The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP).
- Conditions
- Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia
- Trial name
- NCT06620237
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 14 sites in Australia, Belgium and 3 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
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