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

Phase 4TerminatedNCT01057394

CardioFocus21 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Paroxysmal Atrial Fibrillation

Interventions

Endoscopically guided PVI AblationDEVICE

Endoscopically Guided Ablation using the EAS-AC

RF PVI AblationDEVICE

Radiofrequency ablation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

* Symptomatic, Paroxysmal Atrial Fibrillation (AF) * 18 to 75 Years of age * Generally good overall health as determined by multiple criteria * Willing to participate in a study * Others

Locations (2)

Institute for Clinical and Experimental Medicine (IKEM)

Prague, Czechia

Catholic University of the Sacred Heart

Rome, Italy

Outcomes

Primary Outcomes

Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation

Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).

Time frame: 3 Months

Data from ClinicalTrials.gov

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