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

NCT01057394 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-08-01

Study results available
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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

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

Endoscopically guided PVI Ablation

Endoscopically Guided Ablation using the EAS-AC

DEVICE

RF PVI Ablation

Radiofrequency ablation

Sponsors & Collaborators

  • CardioFocus

    lead INDUSTRY

Principal Investigators

  • Vivek Reddy, MD · The Mount Sinai Hospital, New York City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Czechia
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01057394 on ClinicalTrials.gov