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

CardioFocus

Status and phase: Terminated; Phase 4

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: RF PVI Ablation; Device: Endoscopically guided PVI Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01057394

25-2758

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Radiofrequency Ablation

Active Comparator group

Description:

PVI using RF ablation

Treatment:

Device: RF PVI Ablation

Visually Guided Ablation

Experimental group

Description:

PVI using visually guided ablation with an endoscopic ablation system

Treatment:

Device: Endoscopically guided PVI Ablation