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

Phase 4

Terminated

• Conditions: Paroxysmal Atrial Fibrillation

• Registration Number: NCT01057394
• Lead Sponsor: CardioFocus

Brief 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

Detailed 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 Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Study First Posted: 2010-01-27
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2016-04-18
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-27
• Last Update Submitted: 2016-07-27
• Results First Posted: 2016-08-01
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation	3 Months	Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).

Trial Locations

Locations (2)

Institute for Clinical and Experimental Medicine (IKEM); 🇨🇿 Prague, Czech Republic

Catholic University of the Sacred Heart; 🇮🇹 Rome, Italy