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

This study has been terminated.

(Sponsor stopped study for business reasons; not for clinical or clinical outcomes reasons.)

Sponsor:

Information provided by (Responsible Party):

CardioFocus

ClinicalTrials.gov Identifier:

NCT01057394

First received: January 26, 2010

Last updated: July 27, 2016

Last verified: July 2016

History of Changes

Results First Received: April 18, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Paroxysmal Atrial Fibrillation
Interventions:	Device: Endoscopically guided PVI Ablation Device: RF PVI Ablation

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Sponsor stopped the study for business reasons before any participants were enrolled in the RF arm.

Reporting Groups

	Description
Radiofrequency Ablation	Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
Visually Guided Ablation	Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation

Participant Flow: Overall Study

	Radiofrequency Ablation	Visually Guided Ablation
STARTED	0	21 ^[1]
COMPLETED	0	19 ^[2]
NOT COMPLETED	0	2
Not eligible	0	2

[1]	21 enrolled participants
[2]	19 treated participants

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Visually Guided Ablation	Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation

Baseline Measures

	Visually Guided Ablation
Number of Participants [units: participants]	21
Age [units: years] Mean (Standard Deviation)	59 (8)
Gender [units: participants]
Female	9
Male	12
Region of Enrollment [units: participants]
Czech Republic	16
Italy	5

Outcome Measures

1. Primary:

Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation [ Time Frame: 3 Months ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Burke Barrett, VP, Regulatory & Clinical Affairs
Organization: CardioFocus, Inc.
phone: 508 658-7200
e-mail: bbarrett@cardiofocus.com

Responsible Party:	CardioFocus
ClinicalTrials.gov Identifier:	NCT01057394 History of Changes
Other Study ID Numbers:	25-2758
Study First Received:	January 26, 2010
Results First Received:	April 18, 2016
Last Updated:	July 27, 2016
Health Authority:	Europe: Post-market study

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