Clinical trials: PFA
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
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.
Osteoarthritis, Knee, Patellofemoral Knee Arthroplasty
Study of Knee Replacements for Patellofemoral Osteoarthritis
This is a randomized comparison of PFA and TKR in treatment of isolated patellofemoral osteoarthritis.
- Trial name
- PFA/TKR (NCT01326156)
- Testing
- Knee arthroplasty
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- University of Aarhus
Effect of Drug
PFA 100 Evaluation and Reference Interval HOACNY
The purpose of this research is to evaluate instrument functionality and develop a reference range of normal data by healthy volunteers.
- Trial name
- NCT06100510
- Testing
- Aspirin 325mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hematology Oncology Associates of Central New York
Paroxysmal Atrial Fibrillation
3-Dimensional Mapping System: The PULSTAR Study
The purpose of this study is to verify the safety and efficacy of the cardiac pulse ablation system in paroxysmal atrial fibrillation to provide the basis for product registration and clinical application.
- Trial name
- NCT05618340
- Testing
- Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation Catheter
- Where
- China
- Volunteers
- 149 people
- Sponsor
- Shanghai Shangyang Medical Technology Co., Ltd.
Paroxysmal Atrial Fibrillation (PAF)
Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation
This is a prospective, randomized clinical trial, which will be conducted in selected European centers. The objective is to compare two commonly used strategies to guide pulsed-field ablation (PFA) in patients with paroxysmal…
- Trial name
- PFA-VISION (NCT07772518)
- Testing
- In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping.
- Where
- 8 sites in Croatia, Czechia and 6 more
- Volunteers
- 292 people
- Sponsor
- Mitera Hospital
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
Kidney Failure, Acute, Kidney Failure, Chronic
Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy?
The kidneys are highly vascular organs and any trauma or surgery poses risk of severe bleeding. Platelet function is an integral part of the blood clotting during the initial, so-called vascular phase.
- Conditions
- Kidney Failure, Acute, Kidney Failure, Chronic, Blood Platelet Disorders, Hemorrhage
- Trial name
- NCT00334204
- Testing
- measuring Platelet Function Analyser-100 (PFA-100) platelet function before kidney biopsy
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- University of Mississippi Medical Center
Atrial Fibrillation (AF)
Efficacy and Safety of Pulsed Field Ablation in Refractory Mitral Isthmus-dependent Atrial Flutter: Pulsed Field Ablation Vs. Radiofrequency Ablation: a Preliminary Randomized Controlled Study
Efficacy and safety of pulsed field ablation in refractory mitral isthmus-dependent atrial flutter: pulsed field ablation vs. radiofrequency ablation: a preliminary randomized controlled study
- Trial name
- NCT06850064
- Testing
- Pulse Field Ablation (PFA), Radiofrequency ablation
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Shanghai Chest Hospital
Atrial Fibrillation (AF), Persistent Atrial Fibrillation
Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)
Conquer-AF is a prospective, multi-center, interventional, non-randomized clinical study that will enroll up to 400 subjects at up to 30 sites across the United States, Europe, and Australia.
- Conditions
- Atrial Fibrillation (AF), Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation (PAF)
- Trial name
- Conquer-AF (NCT07298473)
- Testing
- Sphere-9 Catheter Ablation
- Where
- 30 sites in United States, Australia and 4 more
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Plantar Fasciitis
A Study to Assess Collagenase Clostridium Histolyticum (CCH) in the Treatment of Plantar Fasciitis (PFA)
This study will assess the efficacy, safety, and tolerability of 2 different doses of collagenase clostridium histolyticum (CCH) (previously known as EN3835) compared to placebo.
- Trial name
- NCT06169319
- Testing
- Collagenase Clostridium Histolyticum (CCH)
- Where
- 39 sites in United States
- Volunteers
- 231 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Paroxysmal Supraventricular Tachycardia, Catheter Ablation
Outcomes of PFA Vs. RFA for Patients with PSVT: a Retrospective and Propensity Score Matching Study
The goal of this retrospective study is to compare the long-term follow-up outcomes of pulses field ablation (PFA) Vs. radiofrequency ablation (RFA) for the patients with paroxysmal supraventricular tachycardia (PSVT).
- Trial name
- PFA*RFA*PSVT (NCT06573853)
- Testing
- Focal Pulsed Field Ablation (PFA), Focal Radiofrequecy Ablation (RFA)
- Where
- China
- Volunteers
- 428 people
- Sponsor
- Caijie Shen
Persistent Atrial Fibrillation, Atrial Fibrillation (AF)
Atrial Remodeling After PFA Substrate Modification for Persistent AF (PeAF)
Atrial fibrillation (AF) is associated with both electrical and structural remodeling of the left atrium. While successful catheter ablation has been shown to reverse some aspects of atrial remodeling, the impact of pulsed-field…
- Conditions
- Persistent Atrial Fibrillation, Atrial Fibrillation (AF), Atrial Remodeling, Pulsed Field Ablation
- Trial name
- NCT07675395
- Testing
- Pulsed-Field Ablation with FARAWAVE Catheter System
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Taipei Veterans General Hospital, Taiwan
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, PFA Ablation and LAAC Procedures
Left Atrial Appendage Closure With Versus Without Pulsed Field Ablation in Atrial Fibrillation Patients With Mild Symptoms and High Stroke Risk
This study is a prospective, multicenter, single-blinded, randomized controlled trial to investigate whether concomitant left atrial appendage closure (LAAC) and pulsed field ablation (PFA) is more effective than LAAC alone in…
- Trial name
- REVERSE-OPTION (NCT07453940)
- Testing
- LAAC plus PFA for persistent AF with high risk of stroke, LAAC for persistent AF with high risk of stroke
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Sir Run Run Shaw Hospital
Posterior Fossa Ependymal Tumor
Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma
This is a multi-site study of the pharmacodynamic effects and efficacy of metformin in children and young adults with recurrent or progressive Posterior Fossa Group A (PFA) ependymoma.
- Trial name
- PNOC041 (NCT07226453)
- Testing
- Metformin, Planned Surgical Resection, Magnetic Resonance Imaging (MRI)
- Where
- 12 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of California, San Francisco
Benign Prostatic Hyperplasia (BPH)
To Establish the Safety and Effectiveness of the ALPFA GRAIL PFA System for Treating Symptomatic Benign Prostate Hyperplasia (BPH) Also Known as an Enlarged Prostate.
The main goal of this study is to evaluate the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System for treatment of enlarged prostate (BPH) symptoms.
- Trial name
- REBOUND (NCT07592299)
- Testing
- Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- ALPFA Medical
Atrial Fibrillation
A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF
The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial…
- Trial name
- DISRUPT-AF (NCT06335082)
- Testing
- Pulsed Field Ablation
- Where
- 36 sites in United States
- Volunteers
- 10,000 people
- Sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
Benign Prostatic Hyperplasia
A Pilot Study Of The ALPFA Benign Prostatic Hyperplasia (BPH) Pulsed Field Ablation (PFA) System
The ALPFA Medical BPH Pilot Study is a prospective, open label, single arm pilot study to assess the use of the ALPFA BPH PFA System in the treatment of men over the age of 45 with obstructive urinary symptoms associated with…
- Trial name
- NCT06965582
- Testing
- ALPFA BPH PFA System
- Where
- 4 sites in Czechia, Italy and 1 more
- Volunteers
- 100 people
- Sponsor
- ALPFA Medical
Atrial Fibrillation (AF)
Safety and Efficacy of Pulmonary Vein Isolation Using Pulsed-field Ablation (PFA) Combined with Either PFA-based Left Atrial Posterior Wall Isolation or Vein of Marshall Ethanol Ablation in Patients with Persistent Atrial Fibrillation
This study is designed to directly compare the safety and efficacy of PFA-based PVI+PWI vs PFA-based PVI+ VoM alcohol ablation in patients with Persistent AF.
- Trial name
- SAVIOR (NCT06878924)
- Volunteers
- 162 people
- Sponsor
- Texas Cardiac Arrhythmia Research Foundation
Atrial Fibrillation (AF), Bleeding
Concomitant PFA Bsaed PVI Plus LAAC
A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy…
- Conditions
- Atrial Fibrillation (AF), Bleeding, Stroke
- Trial name
- COCONUT_2 (NCT07450755)
- Testing
- Interventional LAA Closure, Pulmonary vein isolation
- Volunteers
- 150 people
- Sponsor
- Asklepios proresearch