Clinical Trials Logo
  1. Home
  2. Paroxysmal Atrial Fibrillation
  3. NCT01057394

Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation — En-GARDE  

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
Post-Market Randomized Controlled Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation GuideD by Electroanatomical Mapping to Achieve Permanent Pulmonary Vein Isolation (En-GARDE)

Clinical Trial Summary

To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.

1. visually guided ablation (VGA) using the EAS-AC and

2. radiofrequency ablation

Clinical Trial Description

The goal of the study was to compare two interventions, visually-guided endoscopic ablation to standard-of-care radiofrequency (RF) ablation. The study was terminated early by the Sponsor for business reasons before any participants were randomized or treated with RF ablation. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01057394
Study type Interventional
Source CardioFocus
Contact
Status Terminated
Phase Phase 4
Start date December 2009
Completion date June 2011
View Details
See also
  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 NCT01913522 - Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration N/A
Completed NCT02610803 - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke N/A
Terminated NCT01925885 - Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF) N/A
Withdrawn NCT01917981 - Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation Phase 3
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