Paroxysmal Atrial Fibrillation Clinical Trial
Official title:
Automated Assessment of Pulmonary Vein Isolation (PVI) Using a Novel EP Recording System (CathVision Cube® System)
A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.
Subjects with paroxysmal or persistent atrial fibrillation (AF) who are indicated to undergo first pulmonary vein isolation (PVI) procedure and meet all eligibility criteria will be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision Cube® System in parallel with the conventional (CE marked) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy. The validation of the automated algorithm for PVI will be performed offline The primary objective is to validate the PVI Analyzer software with a novel EP recording system (CathVision Cube® System) for assisting assessment of isolation status following PVI ablation. The secondary objective is to determine the feasibility of "real-time" assessment of PVI analysis and rhythm dependent performance using the PVI Analyzer and CathVision Cube® System. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05970120 -
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
|
N/A | |
| Recruiting |
NCT06014996 -
Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation.
|
N/A | |
| Completed |
NCT03624881 -
Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
|
Phase 4 | |
| Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
| Recruiting |
NCT05905835 -
Treatment of PAF With the Synaptic System
|
N/A | |
| Active, not recruiting |
NCT05618340 -
PFA for Paroxysmal Atrial Fibrillation
|
N/A | |
| Active, not recruiting |
NCT05534581 -
SINGLE SHOT CHAMPION
|
Phase 4 | |
| Not yet recruiting |
NCT05024630 -
Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Patients With Atrial Fibrillation and hypErtension
|
N/A | |
| Completed |
NCT02610803 -
Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke
|
N/A | |
| Completed |
NCT01913522 -
Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration
|
N/A | |
| Withdrawn |
NCT01917981 -
Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation
|
Phase 3 | |
| Terminated |
NCT01925885 -
Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF)
|
N/A | |
| Completed |
NCT01693107 -
Atrial Fibrillation Force Contact Ablation Study
|
||
| Completed |
NCT01842529 -
Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery
|
Phase 2 | |
| Completed |
NCT00971204 -
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
|
Phase 2 | |
| Recruiting |
NCT05172765 -
Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)
|
N/A | |
| Recruiting |
NCT04529785 -
Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable PV Isolation
|
N/A | |
| Completed |
NCT04022954 -
HD Mapping of Atrial Fibrillation in Asia Pacific
|
||
| Completed |
NCT00964392 -
NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
|
Phase 4 | |
| Recruiting |
NCT03912324 -
Computed Tomogram Myocardial Thickness Map Guided pulmOnary Vein iSolaTion vs. Empirical Pulmonary Vein Isolation in Cryoballoon Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF II)
|
N/A |