Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs (ENABLE)

This study has been terminated.

(Study terminated based on decision of Sponsor.)

Sponsor:

Information provided by (Responsible Party):

CardioFocus

ClinicalTrials.gov Identifier:

NCT00477230

First received: May 21, 2007

Last updated: June 26, 2012

Last verified: June 2012

History of Changes

Results First Received: June 26, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Atrial Fibrillation
Interventions:	Device: Endoscopic Ablation System Drug: Standard Anti-arrhythmic Drug (AAD) Therapy

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
The study was terminated early by the decision of the Sponsor after 64 participants were enrolled and 25 were treated.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None outside of the protocol.

Reporting Groups

	Description
Single Ablation Procedure With Endoscopic Ablation System	Single ablation procedure with Endoscopic Ablation System
Standard Anti-arrhythmic Drug Therapy	Medication as prescribed by physician.

Participant Flow: Overall Study

	Single Ablation Procedure With Endoscopic Ablation System	Standard Anti-arrhythmic Drug Therapy
STARTED	32	32
COMPLETED	12	1
NOT COMPLETED	20	31

Baseline Characteristics

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Reporting Groups

	Description
Single Ablation Procedure With Endoscopic Ablation System	Single ablation procedure with Endoscopic Ablation System
Standard Anti-arrhythmic Drug Therapy	Medication as prescribed by physician.
Total	Total of all reporting groups

Baseline Measures

	Single Ablation Procedure With Endoscopic Ablation System	Standard Anti-arrhythmic Drug Therapy	Total
Number of Participants [units: participants]	32	32	64
Age, Customized [units: Participants]
Less than 18 Years	0	0	0
Greater than or equal to 18 Years	32	32	64
Gender, Customized [units: Participants]
Male	0	0	0
Female	0	0	0
Unknown	32	32	64
Region of Enrollment [units: participants]
United States	32	32	64

Outcome Measures

1. Primary:

Freedom for Symptomatic Episode of Atrial Fibrillation at One Year [ Time Frame: One Year ]

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Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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
This study was terminated early due to Sponsor decision. Therefore, full patient assignement to treatments post-randomziation did not occur. Results and other measures cannot be determined because most patients exited the study before completion.

Results Point of Contact:

Name/Title: Burke T. Barrett, Study Director
Organization: CardioFocus, Inc.
phone: 508 658-7200
e-mail: bbarrett@cardiofocus.com

No publications provided

Responsible Party:	CardioFocus
ClinicalTrials.gov Identifier:	NCT00477230 History of Changes
Other Study ID Numbers:	ENABLE 25-2064
Study First Received:	May 21, 2007
Results First Received:	June 26, 2012
Last Updated:	June 26, 2012
Health Authority:	United States: Food and Drug Administration

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