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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiofrequency Ablation

PVI using RF ablation

Group Type ACTIVE_COMPARATOR

RF PVI Ablation

Intervention Type DEVICE

Radiofrequency ablation

Visually Guided Ablation

PVI using visually guided ablation with an endoscopic ablation system

Group Type EXPERIMENTAL

Endoscopically guided PVI Ablation

Intervention Type DEVICE

Endoscopically Guided Ablation using the EAS-AC

Interventions

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Endoscopically guided PVI Ablation

Endoscopically Guided Ablation using the EAS-AC

Intervention Type DEVICE

RF PVI Ablation

Radiofrequency ablation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No