Clinical trials: PFA
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, 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
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.
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
Concomitant Procedures, Atrial Fibrillation
cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and…
- Conditions
- Concomitant Procedures, Atrial Fibrillation, PFA, LAAC
- Trial name
- OPTION-A (NCT06686485)
- Testing
- FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
- Where
- 37 sites in China, Hong Kong and 4 more
- Volunteers
- 433 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal AF, Atrial Arrhythmia
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF
This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in…
- Conditions
- Paroxysmal AF, Atrial Arrhythmia, Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- BLAST-OFF (NCT07181590)
- Testing
- Pulsed Field Ablation
- Where
- 22 sites in Austria, Belgium and 10 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation (PAF)
A Clinical Study on the Use of a Domestically Produced Cryoablation System Combined With Balloon Cryoablation Technology for the Treatment of Paroxysmal Atrial Fibrillation
To validate the safety and efficacy of balloon cryoablation technology and the accompanying disposable intracardiac mapping electrode catheter and adjustable guide sheath for the treatment of paroxysmal atrial fibrillation.
- Trial name
- Balloon cryoab (NCT07036068)
- Testing
- IceMagic™ CryoAblation Catheter
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Atrial Fibrillation (AF)
Local Potential Measurement In PFA: A Pilot Study
This is a pilot study to collect unipolar signal data during a pulsed field ablation study for the treatment of atrial fibrillation and to test the performance of an algorithm designed to measure the local potential of the…
- Trial name
- NCT06877156
- Where
- Croatia
- Volunteers
- 9 people
- Sponsor
- CathVision ApS
Sun Protection
Determination of Sun Protection in Sunscreen Formulas (Study SR09-15)(P08236)(COMPLETED)
Study to determine the sunscreen protection factor (SPF) and ultraviolet A protection factor (PFA) of 2 sunscreen products containing the combination of zinc oxide and avobenzone with and without ensulizole.
- Trial name
- PFA and SPF (NCT01001975)
- Testing
- Sunscreen Test Code: V53-028, Sunscreen Test Code: V53-030, Standard SPF 4 Sunscreen
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Bayer
Paroxysmal Atrial Fibrillation (PAF)
A Clinical Study on the Use of a Domestically Produced Three-dimensional Cardiac Electrophysiological Mapping System Combined With Pressure Monitoring Technology and Star Mapping Technology for the Treatment of Paroxysmal Atrial Fibrillation.
Validating the safety and efficacy of pressure monitoring technology and star-shaped marking technology for the treatment of paroxysmal atrial fibrillation
- Trial name
- paroxysmal at (NCT07039032)
- Testing
- FireMagic™ Magbot Ablation Catheter 、FireMagic™ TrueForce™ Ablation Catheter
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Persistent Atrial Fibrillation
A Dual Energy Catheter (PFA and RFA) and a PFA Catheter for the Treatment of PeAF
The goal of this clinical trial is to treatment of patients with persistent atrial fibrillation with PFA/RFA. 10 patients will be treated by PFA/RFA catheter or PFA catheter only.
- Trial name
- PFA，RFA，PeAF (NCT06232798)
- Testing
- a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter, catheter ablation
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Paroxysmal AF
AblaView® Unipolar PFA OCR-guided Feasibility Study - First in Man
Exploratory Clinical Investigation to evaluate the feasibility and safety of the AblaView® Unipolar Percutaneous Ablation Irrigated Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation using Polarization…
- Trial name
- NCT06700226
- Testing
- AblaView® Unipolar PFA System
- Where
- Uzbekistan
- Volunteers
- 10 people
- Sponsor
- Medlumics
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.
Ventricular Tachycardia
Evaluation of the DuoVT PFA System for Ventricular Tachycardia
This study is a prospective, non-randomized, single-arm, multicenter study to evaluate the safety and effectiveness of the DuoVT Pulsed Field Ablation (PFA) System.
- Trial name
- EXACT-VT (NCT07706712)
- Testing
- Ablation procedure with DuoVT PFA system
- Where
- 5 sites in Croatia, Czechia and 2 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
PULSED AF Post-Approval Study
PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.
- Trial name
- NCT06578104
- Testing
- PulseSelect™ PFA system
- Where
- 23 sites in United States, Canada and 1 more
- Volunteers
- 580 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
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
Paroxysmal AF
CENTAURI Post-Market Clinical Registry
The objective of this post-market clinical registry is to collect realworld clinical experience across multiple European centers regarding the safety and efficacy of the CENTAURI System
- Trial name
- CENTAURI Regis (NCT07874048)
- Testing
- CENTAURI System in conjunction with commercially available ablation catheters
- Volunteers
- 300 people
- Sponsor
- CardioFocus
Atrial Arrhythmia, Atrial Fibrillation
AcQForce Pulsed Field Ablation-CE
The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
- Trial name
- PFA-AF (NCT05113056)
- Testing
- Acutus Medical Pulsed Field Ablation System
- Where
- Czechia
- Volunteers
- 24 people
- Sponsor
- Acutus Medical
Prostate Cancer
A Prospective, Single-Arm, Pilot Study of the ALPFA BPH PFA System in Men With Low, Intermediate and High-Risk Prostate Cancer
The primary objective of this study is to evaluate the safety and effectiveness of PFA in patients with localized prostate cancer.
- Trial name
- NCT07492381
- Testing
- ALPFA BPH PFA System
- Volunteers
- 50 people
- Sponsor
- ALPFA Medical