Clinical trials: Atrial Fibrillation, Paroxysmal
Atrial Fibrillation
Vimecon CAI Trial for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)
This study is a prospective, non-randomized, single arm, multicenter, CE marking trial for patients with paroxysmal atrial fibrillation to undergo an ablation of the cardiac tissue near the PV.
- Trial name
- CAI (NCT02770989)
- Testing
- Vimecon Laser CAI percutaneous cardiac ablation
- Where
- 3 sites in Belgium, Czechia and 1 more
- Volunteers
- 1 people
- Sponsor
- Vimecon GmbH
Paroxysmal Atrial Fibrillation
Safety-and-effectiveness Clinical Evaluation of Nanosecond-pulse Ablation for Atrial Fibrillation
This study is expected to include 166 subjects and Conducted at 11 research centers；The expected 12 month treatment success rate of using research instruments is 65%. Principle evaluation indexes： 1.
- Trial name
- SCENA-AF (NCT06039722)
- Testing
- Pulse ablation catheter
- Where
- China
- Volunteers
- 166 people
- Sponsor
- Shenzhen Pulsecare Medical Technology Co., Ltd.
Atrial Fibrillation, Afib
Clinical Performance of the AFGen1 Device Over a 7-day Period
AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib.
- Conditions
- Atrial Fibrillation, Afib, Irregular Heart Beat, Arrhythmias, Cardiac
- Trial name
- NCT05295056
- Testing
- AFGen1 Device Wear Test, AFGen 1 Device Single Use
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- TriVirum, Inc.
Paroxysmal Atrial Fibrillation
Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)
The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.
- Trial name
- IRASE-AF (NCT01056328)
- Testing
- SJM Irrigated Cardiac Ablation System, FDA approved Open Irrigated RF Ablation System
- Where
- 30 sites in United States, Canada and 1 more
- Volunteers
- 324 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory…
- Trial name
- TactiSense (NCT03354663)
- Testing
- TactiCath SE
- Where
- 21 sites in United States, Australia and 2 more
- Volunteers
- 156 people
- Sponsor
- Abbott Medical Devices
Paroxysmal AF
FARAPULSE™ Pulsed Field Ablation System
To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.
- Trial name
- NCT06762717
- Testing
- FARAPULSE™ Pulsed Field Ablation system
- Where
- China
- Volunteers
- 501 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation
IMPULSE is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Endocardial Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.
- Trial name
- NCT03700385
- Testing
- IOWA Approach Endocardial Ablation System
- Where
- 2 sites in Czechia, France
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (Paroxysmal)
Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF
This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF).
- Trial name
- VISION AF (NCT06828939)
- Testing
- pulsed field ablation
- Where
- Czechia
- Volunteers
- 100 people
- Sponsor
- CardioFocus
Fibrillation, Atrial
Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.
- Trial name
- NCT00402363
- Testing
- omega-3-acid ethyl esters
- Where
- 178 sites in United States
- Volunteers
- 663 people
- Sponsor
- GlaxoSmithKline
Atrial Fibrillation
Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System
To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal…
- Trial name
- AdmIRE (NCT05293639)
- Testing
- Pulse Field Ablation
- Where
- 30 sites in United States
- Volunteers
- 362 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
- Trial name
- STELLAR (NCT03683030)
- Testing
- Multi-Electrode RF Balloon Catheter
- Where
- 41 sites in United States, China and 1 more
- Volunteers
- 397 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
A Multicenter Feasibility Study With the VERAFEYE Imaging and Guidance System as Anatomical Navigation System
PRISM: A Multicenter Feasibility Study with the VERAFEYE Imaging and Guidance System as Anatomical Navigation System
- Trial name
- PRISM (NCT07686328)
- Testing
- Catheter Ablation
- Volunteers
- 50 people
- Sponsor
- LUMA Vision Ltd.
Paroxysmal Atrial Fibrillation
Pilot Study Evaluating the Toray Satake Balloon Thermal Ablation System for Treatment of Paroxysmal Atrial Fibrillation
The purpose of this study is to collect preliminary safety and effectiveness data evaluating the Toray Satake Balloon Thermal Ablation System (TSB)to treat subjects with symptomatic paroxysmal atrial fibrillation that is…
- Trial name
- NCT01997736
- Testing
- Ablation
- Where
- 4 sites in United States
- Volunteers
- 41 people
- Sponsor
- Toray Industries (America), Inc.
Paroxysmal Atrial Fibrillation
Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation
To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.
- Trial name
- INTERRUPT AF (NCT03729830)
- Testing
- Boston Scientific Open Irrigated Ablation Catheters
- Where
- 26 sites in United States, Germany and 4 more
- Volunteers
- 415 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)
The purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3 system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation Catheter® (PVAC®) guided ablation for the…
- Trial name
- CLARITY-AF (NCT01116557)
- Testing
- Radiofrequency Ablation procedure
- Volunteers
- 79 people
- Sponsor
- Biosense Webster, Inc.
Arrhythmias, Cardiac, Atrial Fibrillation
Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-in-Human Study)
This study is a first-in-human, prospective, multi-center, pre-market single-arm clinical trial to evaluate the Future Cardia™ ICM.
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Bradycardia, Ventricular Tachycardia
- Trial name
- NCT06167434
- Testing
- Future Cardia™ Insertable Cardiac Monitoring (ICM) System
- Where
- Croatia
- Volunteers
- 30 people
- Sponsor
- Future Cardia, Inc
Atrial Fibrillation
A Trial to Determine the Safety, Pharmacokinetics, and Efficacy of OPC-108459 Administered as a Single Intravenous Dose to Patients With Paroxysmal or Persistent Atrial Fibrillation (AF)
To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to patients with paroxysmal or persistent atrial…
- Trial name
- NCT02069119
- Testing
- OPC-108459
- Where
- Japan
- Volunteers
- 48 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Symptomatic Paroxysmal Atrial Fibrillation Without Clinically Significant Heart Diseases
Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation
The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI) performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line therapy in comparison with antiarrhythmic…
- Trial name
- NCT01803438
- Testing
- cryoballoon ablation system, Antiarrhythmic Drugs
- Where
- 19 sites in Argentina, Australia and 7 more
- Volunteers
- 220 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
PRECISION GOLD Post Market Study in Europe of Pulmonary Vein Ablation Catheter (PVAC GOLD)
PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post market clinical study conducted in Europe.
- Trial name
- NCT01767558
- Testing
- Ablation / MRI
- Where
- 11 sites in Belgium, France and 4 more
- Volunteers
- 56 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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.