Clinical trials: Atrial Fibrillation, completed
Paroxysmal Atrial Fibrillation
STOP AF First Post-Approval Study
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
- Trial name
- NCT05227053
- Testing
- Arctic Front™ Cardiac Cryoablation Catheter
- Where
- 11 sites in United States
- Volunteers
- 142 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial…
- Trial name
- PulseSmart (NCT06272981)
- Testing
- Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
- Where
- 7 sites in Australia, Canada
- Volunteers
- 136 people
- Sponsor
- Biosense Webster, Inc.
Arrhythmias, Cardiac, Atrial Fibrillation
To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.
The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode…
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Heart Diseases
- Trial name
- NCT06358391
- Testing
- TS-RF Transseptal Needle, BRK Transseptal Needle
- Where
- South Korea
- Volunteers
- 70 people
- Sponsor
- Starmed
Atrial Fibrillation, Renal Dysfunction
A Real World Evidence Retrospective Data Collection Study of Edoxaban and Rivaroxaban
This study aims to evaluate the recommended once-daily dosing of edoxaban and rivaroxaban in patients with atrial fibrillation (AF) and renal dysfunction in South Korea and Taiwan.
- Trial name
- NCT07874555
- Testing
- Edoxaban, Rivaroxaban
- Where
- 2 sites in South Korea, Taiwan
- Volunteers
- 8,265 people
- Sponsor
- Daiichi Sankyo
Atrial Fibrillation, Stroke Prevention
The GLACE Study: Evaluating CLAAS With ICE Guided LAA Closure
The CLAAS® device will be evaluated for safety and performance in the reduction of stroke in subjects with non-valvular atrial fibrillation under intracardiac echocardiography (ICE) imaging for left atrial appendage closure.
- Trial name
- NCT06580275
- Testing
- CLAAS
- Where
- 4 sites in Czechia, Denmark and 1 more
- Volunteers
- 67 people
- Sponsor
- Conformal Medical, Inc
Atrial Fibrillation
A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of…
- Trial name
- Omny-IRE (NCT05971693)
- Testing
- OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
- Where
- 13 sites in Belgium, Canada and 6 more
- Volunteers
- 188 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation, Tachycardia, Supraventricular
Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial
The clinical study is intended to implement and test the collection and analysis of paired ECG data from the HeartWatch and two comparator devices, an Event Recorder and Holter.
- Conditions
- Atrial Fibrillation, Tachycardia, Supraventricular, Bradyarrhythmia, Ventricular Arrythmia
- Trial name
- PRE-ALERT (NCT05357716)
- Testing
- HeartWatch, Event Recorder, Holter Monitor
- Where
- Canada
- Volunteers
- 7 people
- Sponsor
- HelpWear Inc.
Acute Heart Failure (AHF), Cardiac Arrhythmia
Arrhythmia Detection With MEMO Patch Plus in Patients With Acute Heart Failure
This prospective, multicenter, open-label, single-group exploratory clinical trial evaluates the clinical effectiveness of extended electrocardiographic monitoring with MEMO Patch Plus for detecting clinically significant…
- Trial name
- MMPP-HF (NCT07792772)
- Testing
- MEMO Patch Plus
- Where
- 3 sites in South Korea
- Volunteers
- 45 people
- Sponsor
- HUINNO Co., Ltd
Atrial Fibrillation
Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation
This study is an open-label Phase Ib clinical study with the primary objective of evaluating the safety and tolerability of multiple subcutaneous injections of SHR-2004 injection in patients with atrial fibrillation, and the…
- Trial name
- NCT06280768
- Testing
- SHR-2004 injection
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
Persistent Atrial Fibrillation
iCLAS™ for Persistent Atrial Fibrillation
Clinical study to evaluate the safety and efficacy of the Adagio AF Cryoablation System (iCLAS™) in the ablation treatment of symptomatic, persistent atrial fibrillation (PsAF).
- Trial name
- NCT04061603
- Testing
- Adagio AF Cryoablation System (iCLAS™)
- Where
- 21 sites in United States, Belgium and 2 more
- Volunteers
- 215 people
- Sponsor
- Adagio Medical
Atrial Arrhythmia, Atrial Fibrillation
VOLT-AF IDE Clinical Study
This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™…
- Conditions
- Atrial Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- NCT06223789
- Testing
- Pulsed Field Ablation
- Where
- 40 sites in United States, Australia and 9 more
- Volunteers
- 392 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
POLARx Post Approval Study (POLARx PAS)
To collect clinical data on safety, effectiveness and procedural success of Boston Scientific's Cardiac Cryoablation System (includes all BSC commercially available POLARx/POLARx Fit catheters) when used to perform pulmonary vein…
- Trial name
- NCT06170606
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
AF - Atrial Fibrillation, Complication
Esophageal Protection Study: A Multicenter Study
Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability.
- Conditions
- AF - Atrial Fibrillation, Complication, Atrio-Esophageal Fistula
- Trial name
- NCT04577859
- Testing
- ensoETM. Esophageal cooling during AF ablation, Esophageal temperature monitoring probe
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 152 people
- Sponsor
- Advanced Cooling Therapy LLC, d/b/a Attune Medical
Atrial Fibrillation
High Gastrointestinal Bleed Risk Outcomes in Patients With Non-valvular Atrial Fibrillation (NVAF) in France
This study is a retrospective analysis of observational cohorts using data from prospectively collected administrative/claims data to investigate treatment patterns, and safety and effectiveness outcomes in patients with NVAF…
- Trial name
- HELIOS-AF (NCT05038228)
- Testing
- Apixaban, Rivaroxaban, Dabigatran
- Where
- United Kingdom
- Volunteers
- 1 people
- Sponsor
- Pfizer
Deep Vein Thrombosis, Atrial Fibrillation
Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device
Comparison of capillary whole blood INR determined by LumiraDx Instrument to venous plasma INR determined by laboratory reference method (IL ACL ELITE PRO) for method comparison and assessment of accuracy and bias by regression…
- Conditions
- Deep Vein Thrombosis, Atrial Fibrillation, Post-Myocardial Infarction Syndrome, Pulmonary Embolism
- Trial name
- OPTIMAL (NCT03682419)
- Testing
- VKA Patients, Non-VKA Patients
- Where
- 3 sites in United Kingdom
- Volunteers
- 420 people
- Sponsor
- LumiraDx UK Limited
Non-Valvular Atrial Fibrillation (NVAF)
A Study Evaluating the Associations Between Clinical Characteristics and Use of Oral Anticoagulants in Italian Elderly Participants With Non-Valvular Atrial Fibrillation
The purpose of this study is to provide real-world data useful to address the factors associated to the administration of oral anticoagulants in the elderly population affected by non-valvular atrial fibrillation (NVAF), in…
- Trial name
- PRESBUS (NCT05232643)
- Where
- Italy
- Volunteers
- 636 people
- Sponsor
- Bristol-Myers Squibb
Atrial Fibrillation (AF), Atrial Arrhythmia
A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:
The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and…
- Conditions
- Atrial Fibrillation (AF), Atrial Arrhythmia, Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation
- Trial name
- FlexPulse IDE (NCT06676072)
- Testing
- PFA Ablation catheter
- Where
- 32 sites in United States, Austria and 2 more
- Volunteers
- 188 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent
Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study
This is a prospective, non-randomized, multi-center, real-world post-market study to collect and evaluate data regarding the performance of the enhanced atrial fibrillation detection algorithm of the Assert-IQTM Implantable…
- Conditions
- Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Cardiac Arrhythmia, Ablation
- Trial name
- Assert-IQ (NCT06172699)
- Testing
- Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device
- Where
- 11 sites in United States
- Volunteers
- 151 people
- Sponsor
- Abbott Medical Devices
Cardiac Arrhythmias, Symptoms and Signs
Confirm Rx Insertable Cardiac Monitor SMART Registry
The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a 12 month period.
- Conditions
- Cardiac Arrhythmias, Symptoms and Signs, Atrial Fibrillation
- Trial name
- NCT03505801
- Testing
- Confirm Rx ICM insertion procedure
- Where
- 113 sites in United States, Algeria and 22 more
- Volunteers
- 1,826 people
- Sponsor
- Abbott Medical Devices
Symptomatic Paroxysmal Atrial Fibrillation (PAF)
FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.
- Trial name
- NCT01490814
- Testing
- Electrical isolation of the pulmonary veins, Electrical isolation of pulmonary veins
- Where
- 19 sites in Czechia, France and 6 more
- Volunteers
- 769 people
- Sponsor
- Medtronic Cardiac Ablation Solutions