Atrial FibrillationPhase 3ABLATENCT00560885

AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation

A Phase 3 study testing AtriCure Bipolar System in people with Atrial Fibrillation, run by AtriCure, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: AtriCure Bipolar System
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 9 sitesUnited States
Study dates: Nov 2007to Dec 2012
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is greater than or equal to 18 years of age
Subject has history of permanent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines
Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
Mitral valve repair or replacement
Aortic valve repair or replacement
Tricuspid valve repair or replacement

Show all 12Show fewer

Coronary Artery Bypass procedures
Atrial Septal Defect Repair
Patent Foramen Ovale closure
Subject's Left Ventricular Ejection Fraction ≥ 30%
Subject is able and willing to provide written informed consent and comply with study requirements
Subject has life expectancy of at least 1 year

Who cannot join

Stand alone AF without indication(s) for concomitant CABG, valve surgery, ASD repair, or PFO closure
Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
Wolff-Parkinson-White syndrome
Prior cardiac surgery (Redo)
Class IV NYHA heart failure symptoms
Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit

Show all 17Show fewer

Documented MI within 6 weeks prior to study enrollment
Need for emergent cardiac surgery (i.e. cardiogenic shock)
Known carotid artery stenosis greater than 80%
LA size greater than or equal to 8cm
Current diagnosis of active systemic infection
Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
Pregnancy or desire to get pregnant within 12-months of the study enrollment
Preoperative need for an intra-aortic balloon pump or intravenous inotropes
Renal failure requiring dialysis or hepatic failure
Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Baylor Heart Hospital
Dallas, Texas, 75230
Inova Fairfax
Falls Church, Virginia, 22042
Spectrum Health
Grand Rapids, Michigan, 49503
Heart Center of Indiana
Indianapolis, Indiana, 46290
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
Mercy Heart Institute
Sacramento, California, 95819
Sutter Health
Sacramento, California, 95819
Munson Medical Center
Traverse City, Michigan, 49684

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About this study

Official title: AtriCure Synergy Bipolar RF Energy Lesions for Permanent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

Conditions: Atrial Fibrillation
Being tested: AtriCure Bipolar System
Keywords: atrial fibrillation, af, ablation, arrhythmia, racing heart, afib, surgical ablation
Medical subject headings: Atrial Fibrillation, Arrhythmias, Cardiac, Tachycardia

What participants receive

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

AtriCure Bipolar SystemDevice
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System

Study groups in NCT00560885
Study group	Role	What they receive
AtriCure Bipolar System	Experimental	The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure. Receives: Device: AtriCure Bipolar System

What is being measured

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

Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.
Measured: 6 Months Post Procedure
Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events.
Measured: 30 days Post Procedure

Secondary outcomes (2)

Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.
Measured: 6 Months Post Procedure
Composite 6-month Post-procedure Major Adverse Event Rate.
Measured: 6 Months Post Procedure

Timeline

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

Nov 2007Dec 2012

First posted20 Nov 2007 (estimated)
Study startNov 2007
Primary completionDec 2009
Study completionDec 2012

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00560885
Sponsor's protocol ID: CP2007-1
Acronym: ABLATE
Status last verified: Mar 2013
First submitted: 19 Nov 2007
Last updated: 29 Mar 2013
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 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AtriCure Synergy Bipolar RF Energy Lesions for Permanent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
ClinicalTrials.gov ID: NCT00560885
Acronym / sponsor ID: ABLATE / CP2007-1
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation, af, ablation, arrhythmia, racing heart, afib, surgical ablation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: AtriCure, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Dec 2009 (actual)
Study completion: Dec 2012 (actual)
First posted: 20 Nov 2007 (estimated)
Results: Posted 14 Mar 2013

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AtriCure Bipolar System	Experimental	Device: AtriCure Bipolar SystemThe AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.

Who may qualify

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

Key inclusion criteria (12 listed)

Subject is greater than or equal to 18 years of age
Subject has history of permanent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines
Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
Subject's Left Ventricular Ejection Fraction ≥ 30%
Subject is able and willing to provide written informed consent and comply with study requirements

Key exclusion criteria (17 listed)

Stand alone AF without indication(s) for concomitant CABG, valve surgery, ASD repair, or PFO closure
Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
Wolff-Parkinson-White syndrome
Prior cardiac surgery (Redo)
Class IV NYHA heart failure symptoms

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
AtriCure Bipolar SystemSurgical bipolar radiofrequency ablation using the AtriCure Bipolar System	Device	AtriCure Bipolar System

Primary outcome

Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.
Time frame: 6 Months Post Procedure
Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
Time frame: 30 days Post Procedure
Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events.

2 secondary outcomes

Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.
Time frame: 6 Months Post Procedure
Composite 6-month Post-procedure Major Adverse Event Rate.
Time frame: 6 Months Post Procedure

Results and safety

Results posted to the registry on 14 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AtriCure Bipolar System	55	47

Primary outcome: Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.

Time frame: 6 Months Post Procedure. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	AtriCure Bipolar System n = 50
Value	74 (60 to 100)

Population analysed: The analysis population included subjects that were evaluable for the Primary Efficacy Endpoint. The completer population excluded 5 subjects. These were 2 post op deaths, 2 deaths beyond 3 months but less than 6 months and 1 subject that withdrew at the 30 day visit.

Primary outcome: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge

Time frame: 30 days Post Procedure. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	AtriCure Bipolar System n = 55
Value	9.1 (0 to 17.9)

Population analysed: Safety was evaluated in all subjects enrolled and treated with the device.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AtriCure Bipolar System	45 of 55 (81.8%)	51 of 55 (92.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
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.

The record lists no contact. Use the official record to reach the sponsor.

9 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 AtriCure Bipolar System in people with Atrial Fibrillation, run by AtriCure, Inc. at 9 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 12 inclusion and 17 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: finished, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 14 Mar 2013). 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?

Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months. (time frame: 6 Months Post Procedure). The study lists 2 primary outcomes in all. 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 NCT00560885.

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 29 Mar 2013.