Clinical trials: Atrial Fibrillation (AF)
Bradycardia, Right Ventricular Pacing
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
The objective of this study is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.
- Conditions
- Bradycardia, Right Ventricular Pacing, Heart Failure, Atrial Fibrillation (AF)
- Trial name
- LBBAP PMCF (NCT07217392)
- Testing
- LBBAP lead
- Where
- 15 sites in Brazil, France and 7 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation (AF)
Single-Use Spherical Pulsed Ablation Catheter for Paroxysmal Atrial Fibrillation
The goal of this clinical trial is to learn if the cardiac pulsed field ablation system, composed of the cardiac pulsed field ablation device, the single-use spherical pulsed ablation catheter, and the optional cardiac…
- Trial name
- NCT07811934
- Testing
- Investigational Cardiac Pulsed Field Ablation (PFA) System, Conventional Radiofrequency (RF) Catheter Ablation System
- Volunteers
- 284 people
- Sponsor
- Shanghai Shineyo Medical Co., Ltd.
Atrial Fibrillation, Maze Procedure
CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation
The primary objective of this Pivotal study is to demonstrate the safety and effectiveness of the Pulse Biosciences nsPFA™ Cardiac Surgery System in treating atrial fibrillation during concomitant cardiac surgical procedures.
- Conditions
- Atrial Fibrillation, Maze Procedure, AF, Ablation
- Trial name
- NANOCLAMP-AF (NCT06959121)
- Testing
- CellFX® nsPFA™ Cardiac Surgery System
- Where
- 3 sites in United States
- Volunteers
- 135 people
- Sponsor
- Pulse Biosciences, Inc.
Paroxysmal AF
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives.
- Trial name
- Horizon 360 (NCT07308847)
- Testing
- Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
- Where
- 24 sites in United States
- Volunteers
- 300 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation (AF), Paroxysmal AF
Dose Escalation Study to Assess Safety, Tolerability, and Efficacy of Budiodarone Treatment With Non-permanent Atrial Fibrillation
This multicenter, open-label study aims to assess the safety, tolerability and efficacy of budiodarone in treating participants with non-permanent AF, in particular paroxysmal atrial fibrillation (PAF).
- Trial name
- Harbor-AF (NCT07792239)
- Testing
- Budiodarone 200 mg BID, Budiodarone 400 mg BID, Budiodarone 600 mg BID
- Where
- 4 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Xyra, LLC
Atrial Fibrillation (AF)
Detection of Atrial Fibrillation Using PPG From Smartphone Cameras
The protocol is designed to enroll patients from at least 3 diverse clinical sites with smartphones who are being evaluated for the presence or absence of atrial fibrillation (AF) using the Heart Rhythm Software algorithm running…
- Trial name
- FLASH AF (NCT07779213)
- Testing
- 12 Lead ECG is compared to a smartphone based PPG
- Where
- 5 sites in United States, Netherlands
- Volunteers
- 554 people
- Sponsor
- Happitech BV
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Hummingbird ICE Study
The goals of this observational study are to collect data and ultrasound images using the Philips VeriSight Pro intracardiac echocardiography (ICE) catheter to assess safety and effectiveness and to support development efforts of…
- Conditions
- ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF), Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT07552272
- Testing
- ICE Image Guidance
- Volunteers
- 1,000 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Atrial Fibrillation (AF), Stoke
Abbott Medical - VERITAS Study
The primary objective of this study is to evaluate the safety and effectiveness of Abbott's Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients who have non-valvular atrial fibrillation and who are…
- Trial name
- NCT06707688
- Testing
- Amulet™ 2 Left Atrial Appendage (LAA) Occluder
- Where
- 35 sites in United States, Belgium and 7 more
- Volunteers
- 458 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation (AF)
Study to Evaluate the effIcacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral Anticoagulation
This OLE part is an optional, single arm, multicenter, open-label extension (OLE) added to the core part to assess the long-term safety, tolerability, the incidence of ischemic stroke or SE and bleeding events of abelacimab in…
- Trial name
- LILAC-TIMI 76 (NCT07739888)
- Testing
- Abelacimab
- Volunteers
- 2,500 people
- Sponsor
- Novartis Pharmaceuticals
Atrial Fibrillation (AF), Atrial Fibrillation With Rapid Ventricular Response
Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
The purpose of this retrospective study is to evaluate the clinical performance of SMD-RVECG, an artificial intelligence-based medical device software that analyzes single-lead electrocardiogram data to predict the risk of atrial…
- Trial name
- AFRVR (NCT07722039)
- Testing
- SMD-RVECG
- Volunteers
- 348 people
- Sponsor
- HUINNO Co., Ltd
Atrial Fibrillation (AF), Atrial Fibrillation New Onset
Clinical Validation of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours Using Single-Lead ECG Data
The purpose of this retrospective study is to evaluate the clinical performance of SMD-AFECG, an artificial intelligence-based medical device software that predicts the risk of atrial fibrillation occurring within 2 hours using…
- Trial name
- NCT07722078
- Volunteers
- 797 people
- Sponsor
- HUINNO Co., Ltd
Atrial Fibrillation (AF), Paroxysmal AF
PulseMagic™ TrueForce™ PAF NMPA Study
This clinical investigation is intended to demonstrate safety and effectiveness of the PulseMagic™ TrueForce™ Ablation Catheter and the PulseMagic™Pulse Field Ablation (PFA) Generator, and Columbus™ 3D EP Navigation System with…
- Conditions
- Atrial Fibrillation (AF), Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation, Atrial Arrhythmia
- Trial name
- PFATrueForce (NCT07720557)
- Testing
- PFA Ablation catheter
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Atrial Fibrillation (AF), Persistant Atrial Fibrillation
Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
- Conditions
- Atrial Fibrillation (AF), Persistant Atrial Fibrillation, Paroxysmal AF
- Trial name
- COHERENT-AF (NCT06784466)
- Testing
- Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
- Where
- 27 sites in United States, Belgium and 4 more
- Volunteers
- 360 people
- Sponsor
- Arga Medtech SA
Atrial Fibrillation (AF), Mitral Valve (MV) Regurgitation
EPX-HTG for Structural Heart Procedures
To investigate and evaluate the benefits of adding EchoPixel Holographic Therapy Guidance to the current standard of care in Structural Heart (SH) procedures.
- Trial name
- EPX-HTG-2026 (NCT07705425)
- Testing
- Left Atrial Appendage Occlusion, Mitral Valve Transcatheter Edge to Edge Repair
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- EchoPixel, Inc.
Atrial Fibrillation (AF)
Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)
A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their…
- Trial name
- LILAC-TIMI 76 (NCT05712200)
- Testing
- Abelacimab
- Where
- 789 sites in United States, Argentina and 33 more
- Volunteers
- 2,500 people
- Sponsor
- Anthos Therapeutics, Inc.
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
Cardiac Arrhythmia, Diagnostic/Monitoring Devices Related to Adverse Incidents
Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch
Heart rhythm disorders are common and significantly impact the lives of those affected and their families. The main problems can be categorized as: a) atrial fibrillation or AF and atrial flutter, b) supra-ventricular tachycardia…
- Conditions
- Cardiac Arrhythmia, Diagnostic/Monitoring Devices Related to Adverse Incidents, Atrial Fibrillation (AF)
- Trial name
- CATCH (NCT06164808)
- Testing
- HeartWatch
- Where
- Canada
- Volunteers
- 300 people
- Sponsor
- HelpWear Inc.
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), Paroxysmal AF
3-Dimensional Mapping System: The PULSTAR II Study
### Study Overview Study Name In simple terms, this study involves using a new device to treat a heart condition called "Paroxysmal Atrial Fibrillation." Sponsor The study is sponsored by a company called Shanghai Shangyang…
- Conditions
- Atrial Fibrillation (Paroxysmal), Paroxysmal AF, Pulsed Field Ablation
- Trial name
- PAF (NCT07586176)
- Testing
- Nanosecond pulsed electric field ablation system; Cardiac Pulsed Electric Field Ablation Catheter
- Where
- China
- Volunteers
- 152 people
- Sponsor
- Shanghai Shangyang Medical Technology Co., Ltd.
Bradycardia Sinus, AV Block
The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG
The goal of this observational study is to assess inter-/intra- ventricular synchrony and ECG characteristics in relation to Micra tip location.
- Conditions
- Bradycardia Sinus, AV Block, Atrial Fibrillation (AF)
- Trial name
- NCT06910059
- Testing
- Observational
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure