Atrial FibrillationPhase 3ENABLENCT00477230

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

A Phase 3 study testing Endoscopic Ablation System and Standard Anti-arrhythmic Drug (AAD) Therapy in people with Atrial Fibrillation, run by CardioFocus at 18 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Atrial Fibrillation
What is being tested?: Endoscopic Ablation System and Standard Anti-arrhythmic Drug (AAD) Therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 18 sitesUnited States
Study dates: Mar 2007to May 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 to 80 years old
Paroxysmal atrial fibrillation (AF)
Frequent episodes of AF
Failed at least 1 drug treatment
Others

Who cannot join

Others

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

University of Michigan
Ann Arbor, Michigan, 48109
Palm Beach Heart Research Institute
Atlantis, Florida, 33462
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705
University of Virginia
Charlottesville, Virginia
Ohio State University
Columbus, Ohio, 43210
Genesis Medical Center
Davenport, Iowa
The Methodist Hospital
Houston, Texas, 77030
Indiana University, Krannert Institute of Cardiology
Indianapolis, Indiana, 46202
St. Luke's-Roosevelt
New York, New York
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
Florida Hospital
Orlando, Florida
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19096
Strong Memorial Hosptial - University of Rochester
Rochester, New York, 14627
William Beaumont Hospital
Royal Oak, Michigan
Mercy General Hospital
Sacramento, California, 95819-3633
University of California at San Francisco
San Francisco, California, 94143
St. John's Health Center
Santa Monica, California
Arizona Arrhythmia Consultants
Scottsdale, Arizona, 85260

Other trials in United States

About this study

Official title: Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF)

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

Conditions: Atrial Fibrillation
Being tested: Endoscopic Ablation System, Standard Anti-arrhythmic Drug (AAD) Therapy
Keywords: AF, PAF, paroxysmal atrial fibrillation, ablation, failed drugs
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endoscopic Ablation SystemDevice
Single ablation procedure with Endoscopic Ablation System
Standard Anti-arrhythmic Drug (AAD) TherapyDrug
Medication as prescribed by physician.

Study groups in NCT00477230
Study group	Role	What they receive
1	Experimental	Single ablation procedure with Endoscopic Ablation System Receives: Device: Endoscopic Ablation System
2	Active comparator	Medication Receives: Drug: Standard Anti-arrhythmic Drug (AAD) Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Freedom for Symptomatic Episode of Atrial Fibrillation at One Year
Measured: One Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007May 2009

First posted23 May 2007 (estimated)
Study startMar 2007
Primary completionMay 2009
Study completionMay 2009

Why it stopped: Study terminated based on decision of Sponsor.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00477230
Sponsor's protocol ID: ENABLE 25-2064
Acronym: ENABLE
Status last verified: Jun 2012
First submitted: 21 May 2007
Last updated: 27 Jun 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF)
ClinicalTrials.gov ID: NCT00477230
Acronym / sponsor ID: ENABLE / ENABLE 25-2064
Conditions: Atrial Fibrillation
Keywords: AF, PAF, paroxysmal atrial fibrillation, ablation, failed drugs
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated based on decision of Sponsor.
Enrolment: 64 participants (actual)
Lead sponsor: CardioFocusIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 23 May 2007 (estimated)
Results: Posted 27 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Device: Endoscopic Ablation SystemSingle ablation procedure with Endoscopic Ablation System
2	Active comparator	Drug: Standard Anti-arrhythmic Drug (AAD) TherapyMedication

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18 to 80 years old
Paroxysmal atrial fibrillation (AF)
Frequent episodes of AF
Failed at least 1 drug treatment
Others

Key exclusion criteria (1 listed)

Others

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Endoscopic Ablation SystemSingle ablation procedure with Endoscopic Ablation System	Device	1
Standard Anti-arrhythmic Drug (AAD) TherapyMedication as prescribed by physician.	Drug	2

Primary outcome

Freedom for Symptomatic Episode of Atrial Fibrillation at One Year
Time frame: One Year

Results and safety

Results posted to the registry on 27 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Ablation Procedure With Endoscopic Ablation System	32	12
Standard Anti-arrhythmic Drug Therapy	32	1

Primary outcome: Freedom for Symptomatic Episode of Atrial Fibrillation at One Year

Time frame: One Year. Number. Unit: participants

Population analysed: Early study termination before one year.

Adverse events

Time frame: After treatment and during up to 1 year follow-up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Ablation Procedure With Endoscopic Ablation System	5 of 32 (15.6%)	4 of 32 (12.5%)	Not reported
Standard Anti-arrhythmic Drug Therapy	0 of 32 (0%)	5 of 32 (15.6%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vivek Reddy, MD principal investigator

University of Miami

Andrea Natale, MD principal investigator

Texas Cardiac Arrhythmia

Burke Barrett study director

CardioFocus, Inc.

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Endoscopic Ablation System and Standard Anti-arrhythmic Drug (AAD) Therapy in people with Atrial Fibrillation, run by CardioFocus at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom for Symptomatic Episode of Atrial Fibrillation at One Year (time frame: One Year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00477230.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2012.