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

Phase 4

Terminated

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: RF PVI Ablation; Device: Endoscopically guided PVI Ablation

• 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

Arm && Interventions

Group	Intervention	Description
Radiofrequency Ablation	RF PVI Ablation	PVI using RF ablation
Visually Guided Ablation	Endoscopically guided PVI Ablation	PVI using visually guided ablation with an endoscopic ablation system

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