Clinical trials: Arrhythmias
Atrial Fibrillation
Affera Global Registry
The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with…
- Trial name
- NCT06026345
- Testing
- Affera Platform
- Where
- 20 sites in Austria, Belgium and 11 more
- Volunteers
- 540 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation, Atrial Flutter
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial
- Trial name
- IMPACT (NCT00559988)
- Testing
- Home Monitoring Guided OAC, Physician-Directed OAC
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,718 people
- Sponsor
- Biotronik, Inc.
Paroxysmal Atrial Fibrillation (PAF)
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.
- Trial name
- ZERO-AF (NCT01687166)
- Testing
- Blazer Open-Irrigated Ablation Catheter (Boston Scientific), FDA Approved Open-Irrigated Ablation Catheter
- Where
- 38 sites in United States, Australia and 7 more
- Volunteers
- 398 people
- Sponsor
- Boston Scientific Corporation
Ventricular Tachycardia
Unpinning Termination Therapy for VT (US)
This observation study evaluates the safety and performance of UPT therapy in subjects during either an indicated ventricular tachycardia ablation procedure or an ICD implant procedure.
- Trial name
- NCT03093051
- Testing
- Unpinning Termination therapy
- Where
- 7 sites in United States
- Volunteers
- 6 people
- Sponsor
- Cardialen, Inc.
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
Ventricular Tachycardia, Ventricular Fibrillation
OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator
This study evaluates the date of the first appropriate and/or inappropriate therapy in patients implanted with a Guidant PRIZM or VITALITY defibrillator and is evaluating eventual predictive risk factors for…
- Trial name
- NCT00180375
- Testing
- Prizm, Vitality, Renewal
- Where
- 33 sites in France
- Volunteers
- 636 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Exploring the Efficacy of Once Daily Oral Rivaroxaban for Treatment of Thrombus in Left Atrial/Left Atrial Appendage in Subjects With Nonvalvular Atrial Fibrillation or Atrial Flutter
A study for subjects with atrial fibrillation (AF) or atrial flutter who are diagnosed with left atrial (LA) or left atrial appendage (LAA) thrombus. The study will assign subjects to rivaroxaban for treatment of thrombi.
- Trial name
- X-TRA (NCT01839357)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 31 sites in Bulgaria, France and 5 more
- Volunteers
- 60 people
- Sponsor
- Bayer
Bradycardia
Micra Transcatheter Pacing System Continued Access Study Protocol
Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).
- Trial name
- NCT02488681
- Testing
- Micra Pacemaker Implant
- Where
- 29 sites in United States
- Volunteers
- 285 people
- Sponsor
- Medtronic
Cardiac Arrhythmia
FibriCheck Data Registry
The goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (PPG) measurements with simultaneously recorded electrocardiography (ECG) data to evaluate the…
- Trial name
- FDR (NCT06282393)
- Testing
- FibriCheck recordings
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- Qompium NV
Paroxysmal Atrial Fibrillation
Electrical Coupling Information From The RHYTHMIA HDx Mapping System and DIRECTSENSE Technology In The Treatment of Paroxysmal Atrial Fibrillation (LOCALIZE CF)
The objective of this study is to evaluate whether local impedance (DIRECTSENSE™) drop on the INTELLANAV STABLEPOINT™ ablation catheter is associated with late pulmonary vein (PV) reconnections and durable conduction block in…
- Trial name
- LOCALIZE CF (NCT04740801)
- Testing
- Ablation procedure
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.
- Trial name
- NCT00971204
- Testing
- CardioFocus HeartLight Endoscopic Ablation System
- Where
- 10 sites in United States
- Volunteers
- 100 people
- Sponsor
- CardioFocus
Ventricular Fibrillation, Ventricular Tachycardia
Shockless Implant Evaluation
This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks.
- Trial name
- SIMPLE (NCT00800384)
- Testing
- Implantable defibrillator
- Where
- 85 sites in Australia, Austria and 16 more
- Volunteers
- 2,500 people
- Sponsor
- Boston Scientific Corporation
Tachycardia, Ventricular Arrythmia
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
The study is designed to characterize the acute safety and performance of the EV ICD System for Japanese patients.
- Trial name
- NCT07091916
- Testing
- Defibrillation using the Extravascular ICD
- Where
- Japan
- Volunteers
- 14 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch
The goal of this study is to validate the Fitbit ECG software algorithm's ability to detect atrial fibrillation using data derived from a Fitbit wrist-worn consumer device that features a single lead ECG.
- Trial name
- NCT04176926
- Testing
- Electrocardiogram
- Where
- 10 sites in United States, Greece
- Volunteers
- 472 people, healthy volunteers welcome
- Sponsor
- Fitbit LLC
Hypertension Resistant to Conventional Therapy, Bradycardia
Safety and Performance Study of the Moderato System
The purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce…
- Conditions
- Hypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular Block
- Trial name
- NCT02282033
- Testing
- The Moderato System
- Where
- 10 sites in Austria, Chile and 5 more
- Volunteers
- 57 people
- Sponsor
- BackBeat Medical Inc
Heart Failure, Arrhythmias, Cardiac
Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement in Japan (J-HomeCARE II)
The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Home Monitoring technology.
- Trial name
- NCT01221649
- Testing
- ICD/CRT-D
- Where
- 4 sites in Japan
- Volunteers
- 198 people
- Sponsor
- Biotronik Japan, Inc.
Rapid Arrhythmia, Atrial Fibrillation (AF)
Safety and Efficacy Study of the First Domestically Produced FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter Therapy for Rapid Arrhythmia With Tissue Temperature Measurement Function
This project aims to evaluate the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.
- Conditions
- Rapid Arrhythmia, Atrial Fibrillation (AF), Paroxysmal Supraventricular Tachycardia (PSVT)
- Trial name
- NCT07032948
- Testing
- FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System
- Volunteers
- 300 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Ventricular Tachycardia, Monomorphic
Fast VT Episodes Are Terminated by ATP One Shot
Many arrhythmias detected in the ventricular fibrillation (VF)-zone picture monomorphic ventricular tachycardia (VT) and, hence, could be terminated by antitachycardia pacing (ATP) treatment.
- Trial name
- FavoriteATP (NCT00617578)
- Testing
- ATP One Shot ON, ATP One Shot OFF
- Where
- 14 sites in Austria, Finland and 2 more
- Volunteers
- 194 people
- Sponsor
- Biotronik SE & Co. KG
Sick Sinus Syndrome, Paroxysmal Atrial Fibrillation
Optimal Sensing in Atrial Tachyarrhythmia's Study
The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT), and the rejection of far field sensing of…
- Trial name
- OSAT (NCT01074749)
- Testing
- Accent Pacemaker
- Where
- Netherlands
- Volunteers
- 111 people
- Sponsor
- Abbott Medical Devices
Arrhythmia, Sinus Node Disease
PANORAMA Observational Study
To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with or without cardiac resynchronization therapy)…
- Conditions
- Arrhythmia, Sinus Node Disease, Heart Failure, Heart Block
- Trial name
- NCT00382525
- Testing
- Cardiac Rhythm Management device
- Where
- 27 sites in Belgium, India and 4 more
- Volunteers
- 8,586 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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