Clinical trials: Arrhythmia Atrial
Atrial Arrhythmias
The Field PULSE Study
This is a pre-market, first-in-human, pilot, interventional, clinical investigation that aims to evaluate safety and feasibility of the FieldForce™ Ablation system in patients with atrial fibrillation who are indicated for an AF…
- Trial name
- NCT06452589
- Testing
- FieldForce Ablation System
- Where
- Czechia
- Volunteers
- 35 people
- Sponsor
- Field Medical
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
Atrial Arrhythmia, Atrial Fibrillation
VOLT CE Mark 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
- NCT06106594
- Testing
- Pulsed Field Ablation
- Where
- 11 sites in Australia, Austria and 5 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation Paroxysmal, Cardiac Ablation
NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System
The objective of this study is to demonstrate the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Cardiac Catheter Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal…
- Conditions
- Atrial Fibrillation Paroxysmal, Cardiac Ablation, Cardiac Arrhythmia
- Trial name
- NANOPULSE-AF (NCT07018596)
- Testing
- CellFX nsPFA Cardiac Catheter System
- Where
- Czechia
- Volunteers
- 215 people
- Sponsor
- Pulse Biosciences, Inc.
Atrial Fibrillation Paroxysmal, Cardiac Ablation
CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation
The objective of this study is to demonstrate initial safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA or nano-PFA) 360 Catheter Endocardial Ablation System in treating subjects with atrial…
- Conditions
- Atrial Fibrillation Paroxysmal, Cardiac Ablation, Cardiac Arrhythmia
- Trial name
- NCT06696170
- Testing
- CellFX nano-pFA 360 Endocardial Ablation Catheter System
- Where
- 3 sites in Belgium, Czechia and 1 more
- Volunteers
- 60 people
- Sponsor
- Pulse Biosciences, Inc.
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, Arrhythmias, Cardiac
Validation Study of WITHINGS BPM Core for the Detection of Atrial Fibrillation
The proposed clinical study aims to validate the diagnostic performance, compared to a reference ECG, of the electrocardiographic function of the BPM Core developed by Withings for the automatic identification of atrial…
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases
- Trial name
- Core AF (NCT04464499)
- Testing
- ECG measurement
- Where
- 2 sites in France
- Volunteers
- 160 people
- Sponsor
- Withings
Atrial Septal Defect, Atrial Fibrillation
Feasibility Study on the VERAFEYE System
The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure.
- Conditions
- Atrial Septal Defect, Atrial Fibrillation, Atrial Arrhythmia, Left Atrial Appendage Closure
- Trial name
- LUMINIzE (NCT05931835)
- Testing
- VERAFEYE System
- Where
- Ireland
- Volunteers
- 18 people
- Sponsor
- LUMA Vision Ltd.
Atrial Fibrillation Paroxysmal
FOCALFLEX (CE Mark) Study
This clinical investigation is intended to demonstrate safety and effectiveness of the TactiFlex™ Ablation Catheter Sensor Enabled™, the Volt™ Pulse Field Ablation (PFA) Generator, and EnSite™ X EP System with EnSite™ Pulsed…
- Trial name
- NCT06271967
- Testing
- TactiFlex™ Ablation Catheter Sensor Enabled™
- Where
- 24 sites in Australia, Austria and 9 more
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Atrial Arrhythmia
Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation
The goal of this Observational Prospective Multi-center Study is to observe the acute and long-term safety and performance outcomes after spatiotemporal dispersion-based AF/AT ablation utilizing the Volta Medical AI software in…
- Conditions
- Atrial Fibrillation, Atrial Arrhythmia, Arrhythmias, Cardiac
- Trial name
- COMRADE-AI (NCT06083012)
- Testing
- Cardiac mapping
- Where
- 7 sites in France, Germany
- Volunteers
- 186 people
- Sponsor
- Volta Medical
Persistent Atrial Fibrillation, Cardiac Arrhythmia
Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm
To acquire, amplify, digitize, and record atrial intracardiac electrophysiology signals during cardiac electrophysiology studies for the treatment of persistent atrial fibrillation and to use the recorded data to test the…
- Trial name
- NCT05458648
- Testing
- Cardiac Ablation for the treatment of persistent Atrial Fibrillation
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- CathVision ApS
Atrial Arrhythmia, Atrium; Fibrillation
Abbott Atrial Fibrillation Post Approval Study
This post-approval study is designed to provide continued real-world clinical evidence to confirm the safety and long-term effectiveness of atrial fibrillation (AF) radiofrequency (RF) technologies (e.g.
- Conditions
- Atrial Arrhythmia, Atrium; Fibrillation, Atrial Tachycardia
- Trial name
- NCT05434650
- Testing
- electrophysiology study and ablation with an Abbott Ablation Catheter
- Where
- 20 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Paroxysmal or Persistent, Mitral Valve Disease
Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
The study involves endocardial cryoablation of the left and/or right atrium of the heart using the CoolCryo system as an adjunct to mitral valve surgery, with the aim of eliminating atrial fibrillation (AF), which is a common…
- Trial name
- CoolCryo (NCT06557616)
- Where
- 2 sites in Poland
- Volunteers
- 20 people
- Sponsor
- Medinice S.A.
Heart Failure, Arrhythmia
BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software
[Plain language]: Heart failure (HF) patients often experience irregular heartbeats, known as arrhythmias. Atrial fibrillation (AF) is common among HF patients and can worsen their condition, leading to strokes and higher death…
- Conditions
- Heart Failure, Arrhythmia, Decompensated Heart Failure, Atrial Fibrillation
- Trial name
- NCT06989580
- Testing
- BIOMONITOR IV with study software
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 300 people
- Sponsor
- Biotronik SE & Co. KG
Arrhythmias, Cardiac, Paroxysmal Atrial Fibrillation
InsightPFA Trial of the LotosPFA Catheter
This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.
- Trial name
- InsightPFA (NCT06014996)
- Testing
- Pulsed Field Ablation (PFA) Therapy, Radiofrequency Ablation（RAF）Therapy
- Where
- 10 sites in China
- Volunteers
- 292 people
- Sponsor
- Insight Medtech Co., Ltd.
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
Rapid Arrhythmia, PFA
Clinical Study on the Safety and Efficacy of a New Magnetic Navigation Radiofrequency Ablation Catheter for Rapid Arrhythmia
Clinical study on the safety and efficacy of FireMagic™ Magbot Ablation Catheter for rapid arrhythmia
- Conditions
- Rapid Arrhythmia, PFA, Symptomatic Supraventricular Tachycardia
- Trial name
- Rapid arrhythm (NCT07067372)
- Testing
- FireMagic™ Magbot Ablation Catheter
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Healthy Volunteers
Single Ascending Dose, Multiple Ascending Dose, Food Effect Study With AP31969
The primary objective of the study is to evaluate the safety and tolerability of single doses (Part A) and multiple doses (Part B) of AP31969 in healthy participants.
- Trial name
- NCT06066099
- Testing
- AP31969
- Where
- Netherlands
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Acesion Pharma
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