Clinical trials: Pulsed Field Ablation
Paroxysmal Atrial Fibrillation
The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon…
- Trial name
- ADVENT (NCT04612244)
- Testing
- FARAPULSE Pulsed Field Ablation System, RadioFrequency and Cryoballoon Ablation
- Where
- 34 sites in United States
- Volunteers
- 706 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF), Pulsed Field Ablation
3D-Guided Pulsed Field Ablation for Paroxysmal AF
Atrial fibrillation (AF) is a common arrhythmia, especially in the elderly, and can lead to severe complications like stroke and heart failure.
- Trial name
- NCT07023237
- Testing
- pulsed field ablation
- Volunteers
- 430 people
- Sponsor
- Beijing Anzhen Hospital
NSCLC
Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field Ablation Devices in the Treatment of Lung Tumors
The goal of this clinical trial is to verify the efficacy and safety of pulsed electric field (PEF) treatment of early-stage unreseectable non-small cell lung cancer(NSCLC) patients.
- Trial name
- NCT06739031
- Testing
- PEF Treatment
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Energenx Medical LTD.
Atrial Fibrillation, Left Atrial Appendage Occlusion
Pulsed Field Ablation for Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion
This is a single-center, prospective, single-arm clinical trial designed to evaluate the safety and efficacy of pulsed field ablation (PFA) after left atrial appendage occlusion (LAAO) in patients with non-valvular atrial…
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Occlusion, Pulsed Field Ablation
- Trial name
- PFA after LAAO (NCT07313228)
- Testing
- Pulsed Field Ablation
- Volunteers
- 70 people
- Sponsor
- First Affiliated Hospital of Ningbo University
Atrial Fibrillation, Persistent Atrial Fibrillation
Feasibility Study of the FARAFLEX Mapping and PFA System
The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or…
- Conditions
- Atrial Fibrillation, Persistent Atrial Fibrillation, Paroxysmal AF
- Trial name
- ELEVATE-PF (NCT06510556)
- Testing
- FARAFLEX Ablation Treatment, ELEVATE-COR Sub-study
- Where
- 4 sites in Belgium, Croatia and 2 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias
The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the FARAPULSE catheter system (FARAWAVE catheter used in combination with the FARASTAR generator), to treat patients with atrial…
- Conditions
- Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Long-standing Persistent Atrial Fibrillation
- Trial name
- PROSPECT (NCT06765356)
- Testing
- Farapulse Catheter System, Low-dose Colchicine
- Where
- 9 sites in United States
- Volunteers
- 275 people
- Sponsor
- Vivek Reddy
Atrial Fibrillation, Arrhythmia
First-time Ablation of Atrial Fibrillation Registry
Atrial fibrillation (AF) is a prevalent cardiac arrhythmia affecting millions globally, with projections indicating a doubling of cases by 2050.
- Trial name
- DIPE (NCT06381245)
- Testing
- PPG-based remote heart rhythm/rate monitoring, ECG-based remote heart rhythm/rate monitoring, Transthoracic and transesophageal echocardiography examination
- Where
- Poland
- Volunteers
- 340 people
- Sponsor
- Medical University of Warsaw
Atrial Fibrillation
A Study to Predict Atrial Fibrillation (AF) Burden in Participants With PAF and PsAF Treated With the VARIPULSE™ PFA Catheter
The purpose of this study is to evaluate how safe VARIPULSE™ Catheter is and how well it works in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and…
- Trial name
- SPECTRA-AF (NCT07788989)
- Testing
- VARIPULSE Catheter System (PVI), VARIPULSE Catheter System (PVI and PWI)
- Where
- United States
- Volunteers
- 2,300 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation (AF)
Measuring Local Potentials in PFA. MULTI PFA (EU)
The study is a prospective, multi-center, exploratory, observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the Affera Sphere 9, FaraWave, PulseSelect, Volt or VariPulse PFA systems.
- Trial name
- MULTI PFA (NCT07379697)
- Volunteers
- 30 people
- Sponsor
- CathVision ApS
Persistent Atrial Fibrillation
FIH Study of PFLotus in Persistent Atrial Fibrillation
Single-shot pulsed-field ablation (PFA) catheters maximize pulmonary vein isolation (PVI) efficiency but are limited for focal or linear ablation.
- Trial name
- PFLotus- FIH (NCT07301190)
- Testing
- Pulse field ablation with the PFLotus catheter
- Where
- China
- Volunteers
- 40 people
- Sponsor
- The Third People's Hospital of Chengdu
Atrial Fibrillation (AF)
The Added Value of Three-dimensional Electroanatomic Mapping For Accurate Delivery Of Pulsed Field Ablation In The Pulmonary Veins Compared To Pulsed Field Ablation With Fluoroscopy And/Or Intracardiac Echocardiography Alone In The Treatment Of Atrial Fibrillation: MAP-PFA Study
This is a randomized control trial that aims to evaluate the added value of electro-anatomical mapping to improve the quality of pulse field ablation lesions during Atrial fibrillation ablation.
- Trial name
- MAP-PFA (NCT07014423)
- Testing
- The Pulsed Field Ablation to Isolate the Pulmonary Vein with the utilization of FARAVIEW mapping software., The Pulsed Field Ablation to Isolate the Pulmonary Vein without the utilization of FARAVIEW mapping software.
- Where
- 2 sites in Netherlands
- Volunteers
- 32 people
- Sponsor
- University Medical Center Groningen
Atrial Fibrillation
A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation
This study is being done to see if a new method for treating a heart rhythm problem called paroxysmal atrial fibrillation (AFib) is safe and works well.
- Trial name
- CSPFA (NCT07572253)
- Testing
- CARTO SOUND™ FAM System with Varipulse™ PFA Catheter
- Volunteers
- 70 people
- Sponsor
- China National Center for Cardiovascular Diseases
Paroxysmal AF
Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation
The VARIFY study is designed to find out how durable pulmonary vein isolation (PVI) is after treatment with the VARIPULSE pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation (AF).
- Trial name
- VARIFY (NCT07236619)
- Testing
- Pulmonary vein isolation with the VariPulse catheter
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Erasmus Medical Center
Atrial Fibrillation
PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study
This study is a prospective, multicenter, randomized, open-label, blinded end-point, controlled clinical trial to investigate the impact of first line pulsed field ablation during 12 months follow-up in patients with early-stage…
- Trial name
- PULSE (NCT07621003)
- Testing
- Ablation of atrial fibrillation (AF)
- Where
- 10 sites in Germany
- Volunteers
- 264 people
- Sponsor
- Asklepios proresearch
Persistent Atrial Fibrillation
Pulsed Field Ablation for the Treatment of Persistent Atrial Fibrillation: Pulmonary Vein Plus Superior Vena Cava Isolation Versus Pulmonary Vein Isolation Alone-A Prospective, Multicenter, Randomized Controlled Study
his study is for people aged 18 to 75 who have persistent atrial fibrillation (AFib) that has lasted less than one year and who are having their first catheter ablation procedure.
- Trial name
- NCT07819175
- Testing
- Pulsed Field Ablation - pulmonary vein isolation, Pulsed Field Ablation - Pulmonary Vein Isolation + Superior Vena Cava Isolation
- Where
- China
- Volunteers
- 340 people
- Sponsor
- Ruijin Hospital
Atrial Fibrillation
Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation
A prospective, two-arm, multi-center, randomized, open-label, pre-market, First-in-Human clinical study designed to provide safety and performance data regarding the use of the Adagio PFA and PFCA Systems in the treatment of PsAF.
- Trial name
- PARALELL (NCT05408754)
- Testing
- Atrial ablation for subject scheduled for a de novo endocardial ablation of symptomatic, drug-refractory PsAF.
- Where
- 6 sites in Belgium, Canada and 4 more
- Volunteers
- 89 people
- Sponsor
- Adagio Medical
Paroxysmal Atrial Fibrillation
ADVENT Post Approval Study
The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.
- Trial name
- ADVENTPAS (NCT06431815)
- Testing
- FARAPULSE™ Pulsed Field Ablation System
- Where
- 30 sites in United States, Brazil and 2 more
- Volunteers
- 228 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Supraventricular Tachycardia
Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）
The purpose of this study was to explore the safety and efficacy of a Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia.
- Trial name
- NCT05770921
- Testing
- Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Ningbo No. 1 Hospital
Nonvalvular Atrial Fibrillation
First in Man Study of Left Atrial Appendage Pulsed Field Ablation Occluder
This is the first in man study of E-SeaLATM developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can achieve pulsed field ablation and mechanical closure of the Left Atrial Appendage simultaneously, this…
- Trial name
- NCT05731882
- Testing
- E-SeaLA, CardioPulse PFA system
- Where
- 3 sites in China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd
Pancreatic Neoplasm, Pancreatic Neuroendocrine Tumor
Endoscopic Ultrasound-Guided Pulsed Electric Field Ablation for the Treatment of Pancreatic Neoplasms
This clinical trial tests the safety and feasibility of endoscopic ultrasound-guided pulsed electric field ablation for the treatment of pancreatic neoplasms.
- Trial name
- NCT07619417
- Testing
- Clinical Intervention or Procedure, Electronic Health Record Review, Endoscopic Ultrasound-Guided Fine-Needle Aspiration of the Pancreas
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Ohio State University Comprehensive Cancer Center