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

Paroxysmal Atrial Fibrillation Clinical Trial

— En-GARDE  

Official title:

Post-Market Randomized Controlled Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation GuideD by Electroanatomical Mapping to Achieve Permanent Pulmonary Vein Isolation (En-GARDE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01057394
• Other study ID #: 25-2758
• Status: Terminated
• Phase: Phase 4
• First received: January 26, 2010
• Last updated: July 27, 2016
• Start date: December 2009
• Est. completion date: June 2011

Study information

• Verified date: July 2016
• Source: CardioFocus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Europe: Post-market study
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Endoscopically guided PVI Ablation
Endoscopically Guided Ablation using the EAS-AC
• RF PVI Ablation
Radiofrequency ablation

Locations

Country	Name	City	State
Czech Republic	Institute for Clinical and Experimental Medicine (IKEM)	Prague
Italy	Catholic University of the Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
CardioFocus

Countries where clinical trial is conducted

Czech Republic,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3 Months	No

External Links

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