Paroxysmal Atrial Fibrillation Clinical Trial
Official title:
The Canadian Atrial Fibrillation Force Contact Ablation Study
This study will be divided into two phases. The purpose of the Phase I registry is to assess
the current force being used for ablation of symptomatic paroxysmal AF in a wide range of
operators in different Canadian centres with the operators being blinded to the contact force
data.
In Phase II of the study, operators will have open use of the force contact data. Phase I and
II data will be compared in order to assess the efficiency of using the THERMOCOOL®
SMARTTOUCH™ catheter.
Atrial fibrillation (AF) is the most common arrhythmia affecting over 5% of the population
above the age of 65 years. The use of percutaneous catheter ablation for symptomatic
management has increased over the last decade. It is well established that AF ablation is
superior to anti-arrhythmic drugs for symptomatic recurrence of AF. Despite this, success
rates with a single procedure for paroxysmal AF is approximately 80% with the majority of
recurrence due to recovery of lesions or "gaps" found at repeat procedures.
In this study, patients with symptomatic paroxysmal atrial fibrillation (AF) will undergo
ablation using a newly Health Canada approved catheter with SmartTouch technology that
enables the measurement of catheter tip contact force and direction inside the heart. The
purpose of Phase I of the study is to assess the current force being used for ablation of
symptomatic paroxysmal AF in a wide range of operators in different Canadian centres with the
operators being blinded to the contact force data.
The secondary objective will be to assess whether lesion recovery, as assessed in redo
procedures, corresponds to contact force measurements. It is hypothesized that gaps found on
repeat procedures will correspond to ablation lesions associated with a lower contact force.
In Phase II, operators will have open use of the force contact data. Phase I and II data will
be compared in order to assess the efficiency of using the SmartTouch catheter. It is
hypothesized that the open use of contact force data will decrease the procedural time and
number of lesions to achieve bidirectional pulmonary vein isolation.
;
| 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 |
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 |