Paroxysmal Atrial Fibrillation Clinical Trial
Official title:
Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation With the Synaptic Compliant Cryoablation Balloon and System
Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI. All subjects will be followed for twelve (12) months after completion of the index ablation procedure.
A multi-center, open-label, prospective, single-arm, pre-market clinical study. Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI. All subjects will be followed for twelve (12) months after completion of the index ablation procedure. Data will be collected at enrollment, procedure, discharge, 1, 3, 6 and 12- months to assess the safety and effectiveness of the System. Testing for recurrence of atrial fibrillation will include a 12-lead ECG at 1, 3, 6 and 12-months post-ablation, weekly event recorder transmissions after the 3- month follow-up visit through the 12-month follow up, and a 24-h continuous Holter ECG recording at 6 and 12-months post ablation. Symptom triggered rhythm monitoring will be used throughout the effectiveness post-ablation period. ;
| 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 | |
| Active, not recruiting |
NCT05534581 -
SINGLE SHOT CHAMPION
|
Phase 4 | |
| Active, not recruiting |
NCT05618340 -
PFA for Paroxysmal Atrial Fibrillation
|
N/A | |
| 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| Withdrawn |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 | |
| Completed |
NCT05043883 -
Automated Assessment of PVI Using a Novel EP Recording System
|
N/A | |
| 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 |