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

• Sponsor: CardioFocus (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00477230
• Collaborator: (none)
• Enrollment: 64
• Locations: 18
• Arms: 2
• Duration (Months): 26
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation. The treatments being compared are:

• A single catheter ablation procedure with the investigational EAS, a visually-guided, light-energy catheter

• Standard drug therapy (antiarrhythmic drugs)

To learn more about the CardioFocus ENABLE investigational clinical study, please contact the study site closest to you.

Eligibility Criteria

Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study eligibility criteria include:

• 18 to 80 years of age

• Frequent episodes of AF

• Failed at least 1 drug treatment for AF (beta-blockers or standard AADs)

• Other criteria

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: Endoscopic Ablation System; Drug: Standard Anti-arrhythmic Drug (AAD) Therapy	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF)
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Single ablation procedure with Endoscopic Ablation System	Device: Endoscopic Ablation System; Single ablation procedure with Endoscopic Ablation System
Active Comparator: 2 Medication	Drug: Standard Anti-arrhythmic Drug (AAD) Therapy; Medication as prescribed by physician.

Outcome Measures

Primary Outcome Measures

1. Freedom for Symptomatic Episode of Atrial Fibrillation at One Year [One Year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 to 80 years old

• Paroxysmal atrial fibrillation (AF)

• Frequent episodes of AF

• Failed at least 1 drug treatment

• Others

Exclusion Criteria:

• Others

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Arrhythmia Consultants	Scottsdale	Arizona	United States	85260
2	Mercy General Hospital	Sacramento	California	United States	95819-3633
3	University of California at San Francisco	San Francisco	California	United States	94143
4	St. John's Health Center	Santa Monica	California	United States
5	Palm Beach Heart Research Institute	Atlantis	Florida	United States	33462
6	Florida Hospital	Orlando	Florida	United States
7	Indiana University, Krannert Institute of Cardiology	Indianapolis	Indiana	United States	46202
8	Genesis Medical Center	Davenport	Iowa	United States
9	University of Michigan	Ann Arbor	Michigan	United States	48109
10	William Beaumont Hospital	Royal Oak	Michigan	United States
11	St. Luke's-Roosevelt	New York	New York	United States
12	Strong Memorial Hosptial - University of Rochester	Rochester	New York	United States	14627
13	Ohio State University	Columbus	Ohio	United States	43210
14	University of Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19096
15	Texas Cardiac Arrhythmia Research	Austin	Texas	United States	78705
16	The Methodist Hospital	Houston	Texas	United States	77030
17	University of Virginia	Charlottesville	Virginia	United States
18	Sentara Cardiovascular Research Institute	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• CardioFocus

Investigators

• Principal Investigator: Vivek Reddy, MD, University of Miami
• Principal Investigator: Andrea Natale, MD, Texas Cardiac Arrhythmia
• Study Director: Burke Barrett, CardioFocus, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CardioFocus
• ClinicalTrials.gov Identifier: NCT00477230
• Other Study ID Numbers: ENABLE 25-2064
• First Posted: May 23, 2007
• Last Update Posted: Jun 27, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by CardioFocus: AF; PAF; paroxysmal atrial fibrillation; ablation; failed drugs
• Additional relevant MeSH terms: Atrial Fibrillation; Anti-Arrhythmia Agents

Study Results

Participant Flow

Recruitment Details	The study was terminated early by the decision of the Sponsor after 64 participants were enrolled and 25 were treated.
Pre-assignment Detail	None outside of the protocol.

Arm/Group Title	Single Ablation Procedure With Endoscopic Ablation System	Standard Anti-arrhythmic Drug Therapy
Arm/Group Description	Single ablation procedure with Endoscopic Ablation System	Medication as prescribed by physician.
Period Title: Overall Study
STARTED	32	32
COMPLETED	12	1
NOT COMPLETED	20	31

Baseline Characteristics

Arm/Group Title	Single Ablation Procedure With Endoscopic Ablation System	Standard Anti-arrhythmic Drug Therapy	Total
Arm/Group Description	Single ablation procedure with Endoscopic Ablation System	Medication as prescribed by physician.	Total of all reporting groups
Overall Participants	32	32	64
Age, Customized (Number) [Number]
Less than 18 Years	0 0%	0 0%	0 0%
Greater than or equal to 18 Years	32 100%	32 100%	64 100%
Sex/Gender, Customized (Number) [Number]
Male	0 0%	0 0%	0 0%
Female	0 0%	0 0%	0 0%
Unknown	32 100%	32 100%	64 100%
Region of Enrollment (participants) [Number]
United States	32 100%	32 100%	64 100%

Outcome Measures

1. Primary Outcome

Title	Freedom for Symptomatic Episode of Atrial Fibrillation at One Year
Time Frame	One Year

Outcome Measure Data

Analysis Population Description

Early study termination before one year.

Arm/Group Title	Single Ablation Procedure With Endoscopic Ablation System	Standard Anti-arrhythmic Drug Therapy
Arm/Group Description	Single ablation procedure with Endoscopic Ablation System	Medication as prescribed by physician.
Measure Participants	0	0

Adverse Events

Time Frame	After treatment and during up to 1 year follow-up.
Arm/Group Title	Single Ablation Procedure With Endoscopic Ablation System		Standard Anti-arrhythmic Drug Therapy
Arm/Group Description	Single ablation procedure with Endoscopic Ablation System		Medication as prescribed by physician.
All Cause Mortality
	Single Ablation Procedure With Endoscopic Ablation System		Standard Anti-arrhythmic Drug Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Single Ablation Procedure With Endoscopic Ablation System		Standard Anti-arrhythmic Drug Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/32 (15.6%)		0/32 (0%)
Cardiac disorders
Mechanical Perforation	4/32 (12.5%)		0/32 (0%)
Pericarditis	1/32 (3.1%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Single Ablation Procedure With Endoscopic Ablation System		Standard Anti-arrhythmic Drug Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/32 (12.5%)		5/32 (15.6%)
Ear and labyrinth disorders
chest pain	2/32 (6.3%)		0/32 (0%)
Injury, poisoning and procedural complications
Medication Intolerance	0/32 (0%)		5/32 (15.6%)
Respiratory, thoracic and mediastinal disorders
diaphragmatic paralysis	2/32 (6.3%)		0/32 (0%)

Limitations/Caveats

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.

More Information

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.