Clinical trials: Pulsed Field Ablation
Persistant Atrial Fibrillation
Ablation With the PFA System With a Large-Area Focal Catheter for the Treatment of Persistent Atrial Fibrillation
The study evaluates the safety and effectiveness of the investigational QuickShot Nav configuration of the CardioWave System for focal catheter ablation of persistent atrial fibrillation (PerAF).
- Trial name
- Quick AF (NCT07281521)
- Testing
- pulsed field ablation
- Where
- 3 sites in Croatia, Czechia
- Volunteers
- 200 people
- Sponsor
- CardioFocus
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation
The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with…
- Trial name
- NEXT PULSE (NCT07575828)
- Testing
- PulseSelect Pulse Field Ablation (PFA) System
- Volunteers
- 320 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation (PFA) by Balloon Catheter With TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
The purpose of this study is to explore preliminary safety and acute effectiveness of pulsed field ablation by the ablation system (pulsed field ablation balloon catheter and TRUPULSE generator) when used for isolation of the…
- Trial name
- ZephIRE (NCT06495216)
- Testing
- Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation (AF)
A Prospective Observational Study Evaluating the Incidence of Silent Cerebral Lesions and Procedural Safety Following Atrial Fibrillation Ablation Using the VARIPULSE™ Pulsed Field Ablation System
Study Type: Observational Study Goal: The goal of this study is to evaluate the incidence and burden of silent cerebral lesions (SCLs) detected on brain magnetic resonance imaging (MRI) after pulsed field ablation (PFA) for…
- Trial name
- VARIACE (NCT07363278)
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Seoul National University Hospital
Atrial Fibrillation (AF), Catheter Ablation
PulseSelect Based Pulmonary Vein Isolation and Ablation in Patients With Atrial Fibrillation
Electroanatomical mapping (EAM) based pulmonary vein isolation (PVI) by means of PulseSelect catheter and deep sedation will be compared to fluoroscopy based pulmonary vein isolation in patients with atrial fibrillation in the…
- Conditions
- Atrial Fibrillation (AF), Catheter Ablation, Pulmonary Vein Isolation
- Trial name
- PVI-PVA (NCT07035288)
- Testing
- EAM based Pulmonary Vein Isolation, Fluoro based pulmonary vein ablation
- Where
- Greece
- Volunteers
- 40 people
- Sponsor
- Tsiachris Dimitrios
Persistent Atrial Fibrillation
Optimized Posterior Left Atrial Wall Ablation Strategy for PeAF
This is an open-label, multicenter, randomized parallel-controlled clinical trial. The study aims to investigate the optimal ablation method for the posterior left atrial wall in patients with persistent atrial fibrillation…
- Trial name
- NCT06633523
- Testing
- PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM), PVI + Posterior Wall Isolation (PWI), Pulmonary Vein Isolation (PVI) alone
- Volunteers
- 384 people
- Sponsor
- Shanghai Chest Hospital
Atrial Fibrillation, Atrial Tachycardia
Empiric Pulsed Field Pulmonary Vein Isolation During Atrial Tachycardia Ablation in Adults With Congenital Heart Disease
This is a prospective, single-arm intervention trial whereby we will test the safety and efficacy of performing pulmonary vein isolation (PVI) using pulsed field ablation (PFA) in adult patients with congenital heart disease…
- Conditions
- Atrial Fibrillation, Atrial Tachycardia, Atrial Flutter, Congenital Heart Disease
- Trial name
- NCT06969378
- Testing
- Pulsed field ablation using a pentaspline ablation catheter
- Sponsor
- Boston Children's Hospital
Paroxysmal Atrial Fibrillation, Pulsed Field Ablation
Pulsed Field Ablation for Paroxysmal Atrial Fibrillation: Clinical Efficacy and Left Atrial Function Protection
This is a prospective clinical study aiming to evaluate the clinical efficacy and safety of a novel domestic pulsed field ablation (PFA) system in the treatment of paroxysmal atrial fibrillation (PAF), and to specifically assess…
- Conditions
- Paroxysmal Atrial Fibrillation, Pulsed Field Ablation, Catheter Ablation, Left Atrial Function
- Trial name
- NCT07865221
- Testing
- Novel Pulsed Field Ablation System, Radiofrequency Ablation Catheter
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Tianjin Medical University General Hospital
Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System
Application-Based Integrated Care in Patients After Pulse Field Ablation
"Atrial fibrillation (AF) is known as the most common sustained arrhythmia observed in clinical situation. Pulse Field Ablation (PFA) is a recently introduced, effective atrial fibrillation (AF) ablation modality.
- Trial name
- NCT07119528
- Testing
- AF application enhancing AF education, AF application without enhancing AF education and drug adhrence
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- Yonsei University
Persistent Atrial Fibrillation
Evaluation of the Efficacy of Pulmonary Vein Isolation by Pulsed-field Ablation in Persistent Atrial Fibrillation: a Multicenter Study With Follow-up by Implantable Cardiac Monitor
Atrial fibrillation (AF) is the most common sustained arrhythmia in adult population. According to current guidelines for the management of AF, radiofrequency (RF) ablation (including at least pulmonary vein isolation [PVI]) is a…
- Trial name
- PersAF ICM (NCT06985901)
- Testing
- Persistent atrial fibrillation ablation using Pulsed-field ablation
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Atrial Fibrillation
Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA
The study is a prospective, exploratory observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the FaraPulse PFA system.
- Trial name
- REFINE-PFA (NCT07275151)
- Testing
- Pulmonary vein isolation ablation
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- CathVision ApS
Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF)
A Global Randomized Trial Evaluating the FARAFLEX™ Mapping and Pulsed Field Ablation System With Electrographic Flow Mapping in Patients Undergoing Repeat Ablation for Atrial Fibrillation
The goal of the ReDEFINE-AF Clinical Study is to evaluate the safety and effectiveness of the FARAFLEX™ Mapping and Pulsed Field Ablation System with electrographic flow mapping in subjects undergoing repeat ablation for atrial…
- Conditions
- Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF), Paroxysmal Atrial Fibrillation (PAF)
- Trial name
- ReDEFINE-AF (NCT07820930)
- Testing
- FARAFLEX Mapping and Pulsed Field Ablation System
- Volunteers
- 650 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF)
FARAPULSE Workflow Assessment Registry
The study is designed to determine the best practices in the patient pathway, and to analyze pre-procedural, procedural and follow-up workflow data related with ablation of atrial fibrillation where the FARAPULSE™ Pulsed Field…
- Trial name
- FARAWAY (NCT06656884)
- Where
- 28 sites in Austria, Belgium and 8 more
- Volunteers
- 524 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study
The (ADVENT LTO) is an observational, non-significant risk study to assess the progression of atrial fibrillation in subjects who received ablation treatment with either the FARAPULSE Pulsed Field Ablation System or thermal…
- Trial name
- ADVENT LTO (NCT06526546)
- Where
- 25 sites in United States
- Volunteers
- 364 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation, Paroxysmal Atrial Fibrillation (PAF)
Pulsed Field Ablation of SVC and PV in Paroxysmal Atrial Fibrillation (PASPA Study)
The PASPA study is a multicenter, randomized trial comparing Pulmonary Vein Isolation (PVI) alone versus PVI plus Superior Vena Cava Isolation (SVCI) using Pulsed Field Ablation (PFA) in patients with paroxysmal atrial…
- Trial name
- PASPA (NCT07191626)
- Testing
- PFA - PV + SVCI, PFA - PVI only
- Where
- China
- Volunteers
- 650 people
- Sponsor
- Changhai Hospital
Atrial Fibrillation (Paroxysmal)
A Study Evaluating the Effectiveness and Safety of Pulsed Field Ablation Using the FARAPULSE™ System for Electrical Isolation of Pulmonary Veins and Superior Vena Cava
This study is a prospective, single-center, single-arm clinical trial planning to screen and enroll 200 subjects. It aims to evaluate the efficacy and safety of pulsed field ablation (PFA) using the FARAPULSE™ system for…
- Trial name
- NCT07162597
- Testing
- Pulsed Field Ablation
- Volunteers
- 200 people
- Sponsor
- Shanghai Zhongshan Hospital
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
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic…
- Trial name
- OMNY-AF (NCT06455098)
- Testing
- OMNYPULSE™ Catheter with the TRUPULSE Generator
- Where
- 41 sites in United States, Australia
- Volunteers
- 354 people
- Sponsor
- Biosense Webster, Inc.
Combined Pulsed-field Ablation (PFA)
Combined Pulsed-field Ablation (PFA) and Left Atrial Appendage Occlusion Using Watchman Flx or Amulet
AF ablation is an established treatment option for non-valvular atrial fibrillation (NVAF). While AF ablation helps to maintain cardiac rhythm in sinus, the stroke risk associated with AF persists after ablation.
- Trial name
- COMPAWA (NCT05560204)
- Testing
- Combined Pulsed-field Ablation (PFA) + Left Atrial Appendage Occlusion (LAAO)
- Where
- Hong Kong
- Volunteers
- 200 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Atrial Fibrillation (AF)
COCONUT Study Concomitant PVI and LAAC
In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and…
- Trial name
- COCONUT (NCT06861673)
- Testing
- Pulmonary vein isolation
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Asklepios proresearch